The Gap Analysis Checklist - MinthAmericas - Home€¦ · Web viewIATF 16949:2016 Gap Analysis...

Minth North America

IATF 16949:2016 Gap Analysis Checklist

This gap analysis worksheet is intended to identify an organization’s gaps against the criteria of ISO/TS16949:2009. Since IATF 16949:2016 requires process-based audits; this gap analysis checklist is not designed to substitute for your audit worksheets. Persons using this Checklist shall also have a copy of the IATF 16949:2016 with them when undertaking an evaluation. There are some spaces on the checklist that you will need to fill in from the Standard. You will see these as you review the checklist. You will see questions on the checklist that refer to the specification and highlighted in yellow are the ones that are additions to ISO 9001 and required for IATF 16949:2016 compliance of your Quality Management System.

As you work through the checklist take notes on what is in place, and what needs to be developed. Reference procedures or other documents that you have reviewed and that will provide information for the new QMS. Take notes on the status of the documents, will they need to be revised for the new system? Or can they be used as is. Also note where processes are in place, but documentation is needed.

Focus on what is in place, and what needs to be developed. While you do want to know if procedures and processes are being complied with, compliance is not your main focus for this audit. Remember that the final outcome of this audit should be a list of things that the organization needs to do to conform to IATF 16949:2016.

Date of Gap Analysis: ____________________________________

Minth Location or Supplier Location Analysis was undertaken: ________________________________

Name: _________________________________________________________________________

Address: _______________________________________________________________________

Reason for Gap Analysis: __________________________________________________________

Minth Staff Completing the Analysis: ________________________________________________

_______________________________________________________________________________

Supplier or Minth Location Staff supporting the Analysis: ________________________________

_______________________________________________________________________________

MA-PU-402 Rev 2 Date 11 02 2018 IATF 16949:2016 Gap Analysis Work Sheet


4 QUALITY MANAGEMENT SYSTEM

REQUIREMENTS CURRENTLY IN PLACE(List documents or evidence)

CONFORMING Y/N?

Estimated % Complete

ITEMS NEEDED

4.1 General Requirements

This clause asks you to identify how management applies the process approach to achieve the effective and efficient control of processes, resulting in performance improvement. Specifically this section is looking for an overall process evaluation of all quality related processes and their interrelationships. Look to see that your organizational processes are defined and that consideration is given to the items described below.

Is there a Quality Management System in place that has been established and documented to meet the requirements of the IATF 16949:2016 Technical Specification?

Look for documentation of the processes included in the QMS

Look for information on the relationship and sequence of the QMS processes.

Ask Management if operation and control of processes is effective. How do they know if it is effective?




CONFORMING Y/N?


ITEMS NEEDED

Ask how they are able to know if resources and information needed to support processes have been provided.

Is there any information on the effectiveness of processes?

How are improvements made to processes?

Is there implementation of process measure, monitoring and analysis?

What processes does your organization outsource? How are the process controlled?

4.1.1 General Requirements - supplementalDo the controls over outsourced processes ensure your responsibility to conform to all customer requirements?

4.2 Documentation RequirementsThis section addresses how you use documents and records to support effective and efficient operation of your organization. A review of your processes, procedures, work instructions, and records will determine if the standard requirements are met.4.2.1 General




CONFORMING Y/N?


ITEMS NEEDED

Does your quality system documentation include the documentation required by the technical specification IATF 16949:2016?

Is the documentation sufficient to ensure adequate operation of the QMS?

Is the documentation sufficient to ensure adequacy for the size and type or organization, complexity and interaction of processes and competency of personnel?

Does the quality management system documentation include the following:

Documented statements of a quality policy and quality objectives?

A quality manual?

Documented procedures required by IATF 16949:2016? (there are seven)




CONFORMING Y/N?


ITEMS NEEDED

Documents needed by the organization to ensure the effective planning, operation and control of its processes?

Records required by IATF 16949:2016?

Is there a list or other means of identifying other documentation required by your QMS?

Are the required documents available?

Does the QMS documentation include Quality Records?

4.2.2 Quality ManualReview the Quality Manual if available:What is the scope of your QMS?

What processes have been excluded? Is this appropriate?

Is a description or illustration of the interrelation of the processes included?




CONFORMING Y/N?


ITEMS NEEDED

Does the Quality Manual include a scope?

Does the Quality Manual adequately describe the QMS?

Does the Quality Manual document or reference the required documented procedures?

Do employees understand their responsibilities and the processes they deal?

4.2.3 Control of DocumentsA documented procedure is required.

Do you have a formal procedure regarding the control of documents for your organization?

Are documents approved prior to release?

Are documents updated and re-approved prior to release?




CONFORMING Y/N?


ITEMS NEEDED

How are changes identified?

Are documents available to those that need to use them?How is the most current version kept in the correct locations?

Can users easily identify documents? Can users easily read the documents? Are the documents easy and accessible for the employees use?

If documents such as reference books, user’s manuals and other outside documents are used, how are they controlled?

How are old documents handled? Are they removed from use? Are they labeled? Is a copy maintained for reference? Is there any chance that an old document could be used by accident?




CONFORMING Y/N?


ITEMS NEEDED

Does the organization adequately document (revision level, date, etc.) the revision level, date, etc.?

4.2.3.1 Engineering SpecificationsAudit the process for review, distribution and implementation of engineering specifications:

Have they been completed per the customer schedule?

Do the reviews take place within period of (2) working weeks?

Check for record of change implementation into production.

Check updates to affected documents, e.g. Work Instructions, PPAP, Control Plan, FMEA, etc.

What is their process to ensure that the correct revision levels are at the point of use?

4.2.4 Control of Quality Records




CONFORMING Y/N?


ITEMS NEEDED

A documented procedure is required by this clause of the standard.Is there a documented procedure in place for records control?

Where are records kept? Is this identified somewhere so users can easily find records? Can users identify the records? Are the records legible?

How are the retention times, storage requirements, and their disposition identified?

Are they stored in areas and locations are suitable to prevent loss, damage or deterioration?

Can they be retrieved?

How long does it take?

Are records disposed of according to the retention times?




CONFORMING Y/N?


ITEMS NEEDED

If the documents and or records are in the network or Internet, can they be changed?

Are records available on demand? Is there evidence that records are easily retrievable for the organization?

4.2.4.1 Records RetentionDoes record control management satisfy regulatory and customer requirements? Are minimum retention times maintained?



5 MANAGEMENT RESPONSIBILITY


CONFORMING Y/N?


ITEMS NEEDED

5.1 Management CommitmentThis section asks you to identify how your top management demonstrates its leadership, commitment and involvement. Is management communicating the importance of meeting customer requirements? Verify how this is being done, interview personnel to see if this is actually being done. Is the quality policy signed off by top management, do they know it? Review management review meeting minutes. Ask how resources are determined. Remember resources are not limited to people.

Have employees heard about the importance of meeting customer requirements?

What role did Top Management play in communicating this to employees?

What role did Top Management play in establishing the Quality Policy?

What evidence is there of their role?




CONFORMING Y/N?


ITEMS NEEDED

How were the Quality Objective established? (Have they been established?) What evidence is there of Top Management involvement?

Is there a strong linkage between the quality objectives and the quality policy?

Can you see evidence of Top Management involvement in Management review?

What process is used for Top Management to identify and provide resources necessary for the QMS?

Is the organization headed in the right direction, do the management review minutes show positive trends for key measurables such as customer satisfaction, customer returns, delivery, and other key customer expectations identified in 5.2 Customer Focus?




CONFORMING Y/N?


ITEMS NEEDED

Does management show involvement and take action when things are not going in the right direction?

5.1.1 Process EfficiencyDoes organization’s top management monitor the product realization processes and the support processes to assure their effectiveness and efficiency?

5.2 Customer FocusThis is a requirement that may be defined in a document describing how your organization addresses this clause. If no document is available interview top management for compliance. Top management and other personnel should be involved in this section.

Is there a process in place to identify your customer requirements?

How is Top Management involved?

How does Top Management know if customer requirements are being met?

Is your organization aimed at achieving customer satisfaction?

How?




CONFORMING Y/N?


ITEMS NEEDED

Are all types of customers: consumer, client, end user, retailer, and beneficiary identified?

Does the organization gather the type of information that could be translated into physical (dimensional), sensory (smell, touch, taste), behavioral (courtesy, honesty), temporal (punctuality, reliability), ergonomic (linguistic, physiological, human safety), and functional terms?

Do you include the following expectations: satisfaction/dissatisfaction, customer complaints/rejects, product requirements including regulatory and legal and product failure information?

How do expectations translate into requirements?

How is the organization distinguishing between product and business requirements?




CONFORMING Y/N?


ITEMS NEEDED

How are customer requirements prioritized?

Are customer expectations gathered at least once a year with the business planning cycle?

Is the information gathered suitable for converting into requirements, setting objectives, identifying processes, and for improvement?

Does the process provide confidence that fulfilling the requirements will achieve customer satisfaction?

Is the process conducted from a narrow compliance viewpoint or is it conducted with the idea that customer satisfaction is the goal?

5.3 Quality PolicyReview the quality policy, management, personnel, management review meeting minutes and other documents that might apply to this clause for compliance. Evaluate how the quality policy leads to improvements.




CONFORMING Y/N?


ITEMS NEEDED

Is the quality policy appropriate for the organization and aligned with customer expectations, business environment, and management goals?

Does the quality policy include a “commitment to meeting requirements and to continual improvement”?

How does the quality policy provide a framework for establishing and reviewing quality objectives?

What is the relationship between the quality policy and the objectives that are set?

How is it communicated and deployed to be understood at “appropriate” levels of the organization?

Is the quality policy reviewed at a minimum once a year and do the management reviews evaluate the need for change to the quality policy reference?




CONFORMING Y/N?


ITEMS NEEDED

Does the quality policy inspire and lead organization forward?

5.4 Planning5.4.1 Quality ObjectivesReview your defined quality objectives. Do your quality objectives translate your quality policy into measurable goals? Are they documented so all personnel knows what they are and how the objectives apply to their processes? Are the quality objectives being reviewed? Are they measurable? Do the objectives contain commitment to the continual improvement of the QMS?

Review Quality Objectives:Where are objectives defined for meeting product requirements?

At what levels have quality objectives been established? Department? Process?

How are objectives measured?

How do they contribute to meeting the quality policy?

How are the objectives deployed?




CONFORMING Y/N?


ITEMS NEEDED

Do the quality objectives show continual improvement?

If not, why not?

Do the organization’s objectives target the areas that are important to the customer (refer to 5.2 Customer Focus)?

5.4.1.1 Quality Objectives - supplementalAre deployed objectives included in the organization’s business plan?

5.4.2 Quality Management System PlanningReview the documents or evidence in the QMS complying with this clause. Verify planning includes requirements for continual improvement specified in clause 8.1. Verify quality planning includes resources and takes into account the needs of your organization as changes occur.

What quality planning process is in place?

a) How does the planning process address quality objectives for new processes or products?




CONFORMING Y/N?


ITEMS NEEDED

b) How are business and external changes evaluated and approved?

c) Does this take into account how changes will affect the QMS?

Is there evidence of planning for customer-oriented processes and support processes?

Is there Analysis for each process?

Is there evidence that top management is involved in quality planning?

Do the QMS planning records show a continual improvement plan for the objectives and the QMS?

Is the QMS planning driven and linked to the Management Review process?

Is there a process for controlling changes from QMS planning?




CONFORMING Y/N?


ITEMS NEEDED

Does the planning include all the appropriate processes? (such as: Customer Oriented Processes-COPS, Management Oriented Processes-MOPS, Support Oriented Processes-SOPS)

Are the improvement targets appropriate to achieve customer satisfaction?

Will the plan accomplish the task of meeting the customers’ needs and expectations expressed in 5.2 Customer Focus?

5.5 Responsibility, Authority and Communication5.5.1 Responsibility and AuthorityVerify how top management has defined responsibilities and authorities. This information could be in the form of an organizational chart.

Review documentation on responsibility and authority.

Is it defined?

Do employees clearly understand their roles and the organizational lines of authority?




CONFORMING Y/N?


ITEMS NEEDED

5.5.1.1 Responsibility for QualityWhat is the process to notify management with responsibility and authority for corrective action about nonconforming products and processes?

Do personnel responsible for quality have the authority to stop production to correct problems?

Are all shifts staffed with personnel responsible for ensuring product quality?

5.5.2 Management RepresentativeVerify the appointment of the management representative. The management representative is now responsible for implementing and establishing the QMS. Verify how customer requirements are communicated throughout the organization. If more than one management representative is appointed, how are the responsibilities and authorities handled?

Is the management representative a direct report to the CEO / President / General Manager and a part of top management?

Is the management representative actively involved in the implementation and maintenance of the QMS?




CONFORMING Y/N?


ITEMS NEEDED

Does he/she ensure that the processes of the QMS are established and maintained?

Is the Management Representative knowledgeable of the QMS?

Does he/she report to top management on the performance of the QMS and the need for improvement?

Does he/she promote awareness of customer requirements throughout the organization?

Are there meeting minutes, meeting notices, bulletins, and / or newsletters?

Is he/she promoting the correct/important customer requirements?

5.5.2.1 Customer Representative




CONFORMING Y/N?


ITEMS NEEDED

Verify that Top Management has designated personnel to represent the needs of the customer in different areas of the organization (engineering, quality, sales, etc.).

5.5.3 Internal CommunicationVerify the internal communication processes of your organization. It could be in the form of internal memos, bulletin boards, or meetings. Assess the communication for information on the QMS, effectiveness of the processes, and changes to the system. Verify this information is communicated to all levels within the organization.

Has the organization established communication processes?

Do the communications include the effectiveness of the QMS?

What tools does the organization use for internal communication?

Does the communication communicate both process information and its effectiveness?

What processes are they communicating?




CONFORMING Y/N?


ITEMS NEEDED

How are they communicating effectiveness of processes? Is it appropriate?

Do employees understand the status and effectiveness of the QMS, where the organization is headed, and their role and contribution?

5.6 Management Review5.6.1 GeneralReview your management review records for conformance. The requirements for management review input could be presented in an agenda or written in a document. Verify the input requirements are discussed and recorded in your management review record. Review the management review record for compliance to the requirements. If there is a document defining the management review process then this will need to be assessed for conformance. Also management is required to identify customer needs. If new customer needs are identified does management review identify the improvements made to meet these new customer needs?

Is there a schedule for management review?

Does the review frequency ensure the QMS’s suitability, adequacy, and effectiveness?

Are there records or management reviews?




CONFORMING Y/N?


ITEMS NEEDED

Do the organization’s management reviews include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives?

Are the organization’s records from management reviews maintained?

5.6.1.1 Quality Management System PerformanceDo the management reviews include all elements of the quality management system and its performance trends as an essential part of the continual improvement process?

Are they monitoring quality objectives and cost of poor quality?

Is there evidence of achievement of quality policy and business plan objectives?

Do the plans include customer satisfaction with product supplied?




CONFORMING Y/N?


ITEMS NEEDED

5.6.2 Review InputDoes the Management Review Process address all the required Inputs?

a) Results of audits

b) Customer feedback

c) Process performance and product conformity

d) Status of preventative and corrective actions

e) Follow-up actions from previous management reviews

f) Changes that could affect the quality management system

g) Recommendations for improvements

5.6.2.1 Review Input - supplemental




CONFORMING Y/N?


ITEMS NEEDED

Is the analysis of actual and potential field-failures and their impact on quality, safety or the environment included as inputs?

5.6.3 Review OutputDoes the output of management review include actions related to improvement of the QMS?

Does the output of management review include processes, improvement of product related to customer requirements, and resource needs?

Is there evidence that resources are allocated to meet customer satisfaction and QMS objectives?

How are resources allocated?

Are management review inputs presented in such a fashion that management can easily identify the current performance and improvement opportunities of each of the items presented?




CONFORMING Y/N?


ITEMS NEEDED

If the current performance is inadequate, are actions identified in the output to address improvements needed?



6 RESOURCE MANAGEMENT


CONFORMING Y/N?


ITEMS NEEDED

6.1 Provision of ResourcesVerify that resources are available for the QMS. Assess resources for addressing customer satisfaction, implementing and improving the QMS processes. Are resources available in a timely manner? Resources can be people, information, supplies, equipment, facility, work environment, or financial resources.

Is there evidence to show that resources are being provided as needed to develop, maintain and improve the QMS?

Are resources sufficient to meet customer requirements?

Does the resource allocation process provide resources in a timely manner to implement and improve the processes and to address customer satisfaction?

Has management provided adequate resources to meet the continual improvements targeted?

6.2 Human Resources6.2.1 GeneralVerify the training records of personnel, especially as related to sections 4.0, 5.0, 6.0, 7.0, & 8.0 of the standard. If you have a training document, assess the document for compliance to the standard.




CONFORMING Y/N?


ITEMS NEEDED

Evaluate the competence of personnel:

Do the records indicate that the employees are competent to perform the job based upon education, training, skills and experience?

6.2.2 Competence, Training and AwarenessIf there is a training document, verify conformance to the requirements below. If there is no document, determine how personnel know their activities. The standard places great emphasis on competency. Assess how your organization evaluates the effectiveness of training and how personnel know the importance of their activities. This clause applies to all personnel at all levels.

How is the necessary competence of personnel determined and defined?

Has the determined training been provided? Is there on-going continual education training?

And is this training documented in the employees’ training records?




CONFORMING Y/N?


ITEMS NEEDED

Is the effectiveness of the training evaluated?

How?

Is there sufficient evidence?

Are personnel aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?

Are appropriate records maintained describing employees’ education, training, skills and experience?

Are there competency requirements defined for all types of jobs?

Make sure all types of employees are sampled

Have the competency needs of employees affecting quality been identified?




CONFORMING Y/N?


ITEMS NEEDED

Is there a training plan to satisfy these needs?

Is it followed?

Is there new employee orientation and training?

Does it cover relevance and importance of employee activities, and how they relate to the quality objectives?

Are there records for all employees indicating their training, skills education and experience?

Are competent personnel “effectively” carrying out activities and providing results for the organization through improvement?

Are there weaknesses?

6.2.2.1 Product Design Skills




CONFORMING Y/N?


ITEMS NEEDED

Does the organization ensure that personnel with product design responsibility are qualified to achieve design requirements and are skilled in applicable tools and techniques?

Has the organization identified applicable tools and techniques needed for product design?

6.2.2.2 TrainingA documented procedure is required by this clause. Review records to confirm conformance.

Is there a documented procedure for identifying training needs and achieving competence?

Check personnel records against job qualification requirements. Do they indicate that the employees are competent to perform the job based upon education, training, skills and experience?

Audit qualifications of laboratory personnel.




CONFORMING Y/N?


ITEMS NEEDED

Audit qualifications of personnel making appearance item evaluations.

Audit internal auditor qualifications and servicing personnel training.

Are the Quality Management System responsibilities of personnel involved in general responsibilities?

6.2.2.3 Training on the JobIs on-the-job training provided for new and modified jobs?

Is there a process to inform personnel about the consequences to the customer of nonconformities?

6.2.2.4 Employee Motivation and EmpowermentIs there a process for employee motivation?

Is the process helping employees achieve objectives?




CONFORMING Y/N?


ITEMS NEEDED

Is there promotion of quality and technological awareness?

Is there process for measuring awareness of the importance of the activities and contributions to achievement of quality objectives?

Interview personnel in different areas and audit trails to verify awareness (ask with quality policy).

6.3 InfrastructureThis clause addresses how your organization ensures that the infrastructure is appropriate for the achievement of your objectives. Verify the facilities are maintained to achieve the conformity of the product. Safety, maintenance, management review, and meeting minutes are some of the records to review. Different processes within the organization may have different requirements.

What is your infrastructure?

Does product or service meet requirements when produced or delivered using this infrastructure?

Is there adequate space for non-conforming materials or returned product from customer?




CONFORMING Y/N?


ITEMS NEEDED

Are there adequate facilities (lab) for returned product analysis?

Review the maintenance and prevention maintenance process that is used to maintain the facilities. Is it adequate?

6.3.1 Plant, Facility and Equipment PlanningDoes the organization use a multidisciplinary approach for developing plant, facility and equipment plans?

Is the organization’s plant layouts optimized for material travel, handling and value-added use of floor space and shall facilitate synchronous material flow?

Has the organization developed and implemented methods to evaluate and monitor the effectiveness of existing operations?

6.3.2 Contingency Plans




CONFORMING Y/N?


ITEMS NEEDED

Check contingency plans.

Do they consider all possible scenarios?

(such as utility interruptions, labor shortages, key equipment failures and field failures)

6.4 Work EnvironmentExamples to look at for compliance would be work methods, safety, ergonomics, and temperature and humidity controls. Elements that may also be included in work environment are information, suppliers and partnerships, natural and financial resources.

What work environment is needed to meet product or service requirements?

Has this work environment been provided?

Has the organization identified the human and physical factors of their work environment?Physical factors include heat, noise, light, hygiene, humidity, cleanliness, vibration, pollution, and airflow.




CONFORMING Y/N?


ITEMS NEEDED

Has the organization identified work rules for people involvement, safety rules, and ergonomics?

What process do they use to manage the human and physical factors?

Do records show work environment as a root cause for non-conformances?

While walking through the facility, monitor the level of housekeeping. Is there oil on the floor, chips & dirt, cigarette butts, etc?

What is the general work environment as it relates to noise, air quality, etc?

6.4.1 Personnel Safety to Achieve Conformity to Product RequirementsDoes the organization’s quality policy and practices address product safety and means to minimize potential risks to employees, especially in design and development process and in the manufacturing process activities?

6.4.2 Cleanliness of Premises




CONFORMING Y/N?


ITEMS NEEDED

Is there a process for maintaining premises in a state of order, cleanliness and repair?

(e.g., housekeeping / 5S audits)

7 PRODUCT REALIZATION


CONFORMING Y/N?


ITEMS NEEDED

7.1 Planning or Product RealizationThis section may be addressed in a documented procedure or in the quality manual. Does your organization understand the processes needed to meet product requirements? The planning activity for the processes related to product realization must address the requirements in section 4.1.

For each product/project or contract sampled study the planning of the realization process: Is there a quality plan for the process?

Does the plan include appropriate quality objectives?




CONFORMING Y/N?


ITEMS NEEDED

Do the objectives relate to customer requirements and the business goals established in 5.4 Planning?

Was the need to establish new processes and/or change existing product realization process, documentation, resources, and facilities for product identified?

Does the plan specify verification and validation and criteria of acceptability of the product as it goes through each process?

Does the plan identify the records necessary for process and product conformance?

Is the plan output appropriate to the operation?

7.1.1 Planning of Product Realization - supplementalHave the customer requirement and references to its technical specifications been included in the planning of product realization as a component of the quality




CONFORMING Y/N?


ITEMS NEEDED

plan?

How well was the standardized new-product development and manufacturing process customized to meet the specific needs of the particular product?

7.1.2 Acceptance CriteriaIs acceptance criteria defined and approved by the customer if required?

Is acceptance criteria for attributes data sampling at zero defects?

7.1.3 ConfidentialityLook at the processes to ensure product and project confidentiality (limited access, password protection, etc.).

How is computer hardware and software controlled?

What is the process to dispose of hardware and software that may have customer information?Is there a process to protect customer intellectual property?




CONFORMING Y/N?


ITEMS NEEDED

7.1.4 Change ControlIs there evidence of assessment of change impact and change validation before implementation?

Are manufacturing changes included?

Has proprietary designs, impact on form, fit and function been reviewed for proprietary designs?

Are there any additional verifications/identification requirements?

Has the customer been notified about the changes?

7.2 Customer-Related Processes7.2.1 Determination of Requirements Related to the ProductIf customer requirements are not understood there is the possibility of not meeting the customer needs. A review of customer complaints, surveys, and reports will denote any problems. Also look at any contract, logs, or orders to see if any amendments have been made. If so, is the reason for the amendment documented? This requirement also includes recycling, environmental impact and characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes.

How are customer requirements determined?




CONFORMING Y/N?


ITEMS NEEDED

Are product requirements (physical, functional, ergonomic, etc.) identified from the customer including delivery and post-delivery activities determined?

Does the organization add requirements that they identified that were not specified by the customer, but necessary for intended or specified use?

Is there a process for this to happen?

Are obligations related to the product, including regulatory and legal, identified?

Are additional requirements determined by the organization?

Are these requirements input into 5.2 Customer Focus?

Are product requirements gathered only during contract stages?

Does the organization try to analyze / summarize product requirements gathered between customers, by product




CONFORMING Y/N?


ITEMS NEEDED

family, etc… as to input the planning process?

7.2.1.1 Customer-Designated Special CharacteristicsHave special characteristics been identified per customer requirements?

Are the special characteristics identified on drawings, FMEA’s, Control Plans and Work Instructions with customer-designated symbols?

Do employees related to manufacturing and quality understand special characteristics and can identify what they are and how they should be treated?

7.2.2 Review of Requirements Related to the ProductWhen looking at the documents (records, procedure, and work instructions) consider required delivery dates, applicable standards, and any organizational requirements. Is the same process being followed for verbal orders?

How does your organization review customer requirements?

What information is reviewed?

What records are maintained?




CONFORMING Y/N?


ITEMS NEEDED

How are customer requirements confirmed on a verbal order?

How is your ability to meet order requirements confirmed?

How are changes to orders handled?

Does the organization review product requirements for the products sampled from 7.2.1?

Are the product requirements from 7.2.1 reviewed before the commitment to produce is made?

Are differing requirements resolved?

Does the review make sure that they have the ability to meet all requirements before commitment to supply?

Is the review and subsequent actions documented?

When customer requirements or product requirements are changed, are relevant




CONFORMING Y/N?


ITEMS NEEDED

personnel made aware of the change?

Is each order reviewed, documented and approved prior to commitment to the customer?

When the customer provides little to no documented requirements, does the organization review the requirements from 7.2.1 with the customer?

7.2.2.1 Review of Requirements Related to the Product - supplementalWaiving the requirement of the formal review requires customer authorization.

If formal review not performed, is their customer authorization?

7.2.2.2 Organization Manufacturing FeasibilityDoes the organization investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process including risk analysis?

7.2.3 Customer Communication




CONFORMING Y/N?


ITEMS NEEDED

If there is no document available regarding customer communication then the questions below should be asked to determine compliance to this clause. Customer requirements are important and usually involve different levels in the organization. Ask different levels to see if the answers are consistent and do they agree with the organizations policy and objectives.

How do you communicate product information to customers?

What process is used for customer enquiries, contracts or order handling, including amendments?

What mechanism is in place to collect customer feedback, including complaints?

Is the language specified by the customer used for communications?

7.2.3.1 Customer Communication - supplementalDoes the organization have compatible systems to communicate data and information?(Such as CATIA, IDEAS, EDIFACT, etc.)?

7.3 Design and DevelopmentDoes product and manufacturing process design focus on error prevention rather than detection?




CONFORMING Y/N?


ITEMS NEEDED

If your organization does not have a PRODUCT DESIGN and DEVELOPMENT function, the elements associated with PRODUCT DESIGN will not be applicable and exclusion should be noted. However, all MANUFACTURING PROCESS DESIGN cannot be excluded.7.3.1 Design and Development PlanningThis section for planning is done to the level necessary to achieve the design/development objectives. Planning could be in the form of a flow chart (GANTT chart, PERT chart) to give the information. A review of projects and records will determine how this is being done and if consistent with the clause. Advanced Product Quality Planning (APQP) is one acceptable method to develop products and/or manufacturing processes.

How does your organization plan and control the design and development of product?

Sample various products.

For each product that was designed or developed check the following:

Was there a plan for the design and development of the product?

Were the stages of design and or development determined?

Were reviews, verification, and validation activities conducted for each stage?

Were the responsibilities and authorities for these activities identified?




CONFORMING Y/N?


ITEMS NEEDED

How was the interface between the different groups managed for effective communication and clarity of responsibilities?

Was the output of the plan updated as the design or development progresses?

7.3.1.1 Multidisciplinary ApproachDoes the organization use a multi-disciplinary approach to prepare for product realization that includes:

- Development/ finalization and monitoring of special characteristics?

- Development and review of FMEAs including actions to reduce potential risks?

- Development and review of control plans?

7.3.2 Design and Development Inputs Although the standard does not specifically require it, consider preparing a document to address the input requirements in order to avoid any misunderstandings. Review any document or paperwork that addresses this clause.

Continue the same product samples from




CONFORMING Y/N?


ITEMS NEEDED

7.3.1 Design and/or Development Planning:

Were inputs relating to product requirements defined and documented?

Did they include functional and performance requirements?

Did they include applicable regulatory and legal requirements?

Did they include applicable information derived from previous similar designs?

Did they include other requirements essential for design and /or development?

Is there evidence that the inputs were reviewed for adequacy?

Is there evidence that incomplete, ambiguous, or conflicting requirements were resolved?

7.3.2.1 Product Design InputDo documented product design inputs




CONFORMING Y/N?


ITEMS NEEDED

include customer requirements such as identification, traceability, special characteristics, and packaging?

Do design inputs include information from previous designs, feedback, field data, and other sources?

Do design inputs include functional and performance requirements?

Does the organization identify, document and review the product design inputs requirements including:

- Customer requirements (contract review)?

- Use of information (the organization shall have a process to deploy information gained)?

- Targets for product quality, life, reliability, durability, maintainability, timing, and cost?

7.3.2.2 Manufacturing Process Design Input




CONFORMING Y/N?


ITEMS NEEDED

Were inputs for the manufacturing process requirements identified, documented and reviewed?

Does the organization identify, document and review the manufacturing process design input requirements, including:

- Product design output data?

- Targets for productivity, process capability and cost?

- Customer’s requirements if any?

- Experience from previous developments?

7.3.2.3 Special CharacteristicsDo documents include identification of special characteristics?

Does the organization identify special characteristics and:

- Comply with customer specified definitions and symbols?




CONFORMING Y/N?


ITEMS NEEDED

- Identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer’s special characteristic symbol or the organization’s equivalent symbol or notation to include those process steps that affect special characteristics?

7.3.3 Design and Development OutputsVerify the outputs of the design/development satisfy the design/development inputs. Assess the documents that apply to this clause for compliance. This clause does not require a quality record, but to demonstrate compliance some form of quality records should exist.

Continue the same samples from 7.3.1 Design and/or Development Planning:

Were the design outputs documented in a manner that enables verification against the inputs?

Was the output reviewed prior to release?

Did the outputs meet the input requirements?

Did the output provide appropriate information for production and service




CONFORMING Y/N?


ITEMS NEEDED

operations (read as process control, i.e. ongoing functional testing, product characteristics etc.)?

Did it contain or reference product acceptance criteria?

Did it define characteristics of the product essential for safe and proper use?

7.3.3.1 Product Design Outputs -supplementalIs the organization’s product design output expressed in terms that can be verified and validated against product design input requirements?

Does the organization’s product design output include:

- Design FMEA, reliability results?

- Product special characteristics, specifications?

- Product error proofing, as appropriate?




CONFORMING Y/N?


ITEMS NEEDED

- Product definition including drawings?

- Product design reviews results?

- Diagnostic guidelines where applicable?

7.3.3.2 Manufacturing Process Design OutputWere process design outputs expressed in a manner that enables verification and validation against the inputs?

Does the organization’s manufacturing process design output include:- Specifications and drawings?

- Manufacturing process flow chart / layout?

- Manufacturing process FMEAs?

- Control plan?

- Work instructions?

- Process approval acceptance criteria?




CONFORMING Y/N?


ITEMS NEEDED

- Data for quality, reliability, maintainability and measurability?

- Results of error-proofing activities, as appropriate?

- Methods of rapid detection and feedback of product/manufacturing process non-conformities?

7.3.4 Design and Development ReviewVerify the design review record to confirm compliance. Confirm the reviews are taking place, done according to the plan, appropriate attendance at the reviews, and follow up action has taken place. The standard does not require the number of design reviews that should be conducted. The review is intended to confirm internal and external needs have been taken into consideration or addressed.

How do project managers identify the stages of design where design review is required?

What is covered in design review?

Continue to follow the same product samples from 7.3.1 Design and/or Development Planning:

Were design reviews conducted at suitable frequencies?




CONFORMING Y/N?


ITEMS NEEDED

Were they conducted as per the “planned” schedule?

Did the review evaluate the ability to meet the requirements needed at the stage, and identify problems and proposed follow up actions?

Are they accomplishing what is required at the stage?

Did they identify problems and propose action?

Did the review include representatives of the functions involved in that stage of the design?

Was the review well documented including follow-up actions?

7.3.4.1 MonitoringDoes the organization define and analyze measurements at specified stages of design and development and summarize a report of results as an input to management review?




CONFORMING Y/N?


ITEMS NEEDED

7.3.5 Design and Development VerificationVerification considers the product after it is finished. Verification makes the determination that the product meets the stated requirements. This can be done by review of test data, calculations, or additional testing. For verification the capability of the product must meet the specified requirements and there must be objective evidence available to demonstrate it. Assess the records for compliance.

How is verification planned?

What does verification include?

Continue the same product samples from 7.3.1 Design and/or Development Planning:

Was the output of the design or development verified to ensure that it met the inputs?

Did it “ensure” that the output meets the input without any ambiguity?

Were results of the validation and any subsequent follow-up actions recorded?

7.3.6 Design and Development ValidationValidation assures that the design/development output conforms to defined user needs and is capable of meeting the requirements for the intended use. Validation is usually performed after verification. Verify that the requirements of this clause are met by reviewing the validation records.

Continue the same product samples from 7.3.1 Design and/or Development




CONFORMING Y/N?


ITEMS NEEDED

Planning:

How is validation planned?

What is included in validation?Was the output of design or development validated to test whether the product is “capable of meeting the requirements for the specified or intended use or application”?

Note: the validation should be testing the product as close to real use as possible. It should be testing the product under the various conditions or worst conditions that it will be put to use by the customer.

Was the validation completed before delivery or implementation of the product whenever “practicable”?

If full validation was impractical prior to delivery or implementation, was partial validation performed to the extent applicable?

Were the results of the validation and any




CONFORMING Y/N?


ITEMS NEEDED

subsequent follow-up actions recorded?

Does the validation process include an analysis of field reports for similar products?

Does verification and validation evident for both product and manufacturing processes?

7.3.6.1 Design and development validation - supplementalWas the validation completed according to customer requirements and program timing?

7.3.6.2 Prototype ProgramWhen required by the customer, does the organization have a prototype program and control plan?

Wherever possible, does the organization use the same suppliers, tooling and manufacturing processes as will be used in production?

Does the organization monitor all performance testing activities for timely




CONFORMING Y/N?


ITEMS NEEDED

completion and conformance to requirements?

Does the organization take responsibility for the subcontracted services, including technical leadership?

7.3.6.3 Production Approval ProcessWhat is the organization and supplier product and process approval procedure?

Does the organization conform to a product and process approval procedure recognized by the customer?

Does the organization apply a product and process approval procedure recognized by the customer to its suppliers?

7.3.7 Control of Design and Development ChangesSome of changes that may take place are omissions, errors or inconsistencies in the design or requirements, changes in statutory or regulatory requirements, or issues raised during reviews. It is important that changes be documented and actions taken to prevent any possible effect on the product. Assess the design/development records for compliance and verify that changes have been communicated to all parties.

How are changes to the design recorded and implemented?




CONFORMING Y/N?


ITEMS NEEDED

Are the changes verified, validated and approved prior to implementation?

Are the changes evaluated for the effect on constituent parts and delivered products?

Are the results of the review of changes and any necessary actions recorded?

Do design and development changes include all changes during the product program life?

7.4 Purchasing7.4.1 Purchasing processThis clause asks your organization to base the type and extent of control of suppliers on the effect of the purchased material on both the product realization processes and products produced. Assess the records of supplier evaluations and follow up actions.

Is there a process in place to ensure that purchased product conforms to requirements?

Is the control appropriate to effect the purchased product has on the subsequent or final product?

Is there a method of controlling the




CONFORMING Y/N?


ITEMS NEEDED

suppliers?

How are suppliers selected?

What criteria are there for evaluating suppliers?

Are evaluation and any necessary actions being recorded?

Is there a list of approved suppliers?

Does the list include all the appropriate types of suppliers?

Were the suppliers evaluated and selected based upon their ability to supply product in accordance with requirements?

Was there a criteria for their selection?

Were the suppliers periodically evaluated?

Were their criteria for their periodic evaluation?




CONFORMING Y/N?


ITEMS NEEDED

Did they base their purchasing commitments on supplier evaluation?

Are there records of supplier selection and evaluation?

Does the organization’s purchasing process include all products and services that affect customer requirements such as sub-assembly, sequencing, sorting, rework and calibration services?

When there are mergers, acquisitions or affiliations associated with suppliers, the organization should verify the continuity of the supplier’s quality management system and its effectiveness.

7.4.1.1 Statutory and Regulatory ConformityDo purchased products satisfy applicable statutory and regulatory requirements?

7.4.1.2 Supplier Quality Management System DevelopmentIs there evidence of supplier development towards conformance to IATF 16949:2016?




CONFORMING Y/N?


ITEMS NEEDED

Are suppliers registered to ISO 9001:2008?

Sanctioned Interpretation 5: Is the organization’s second party audit process consistent with the automotive process approach, including evidence of planning, supplier readiness and supplier performance?

7.4.1.3 Customer-Approved SourcesWhere specified by the contract, does the organization purchase products, materials or services from approved sources?

Does the organization demonstrate responsibility for ensuring the quality of purchased products supplied by customer-designated sources, including tool/gage suppliers?

7.4.2 Purchasing InformationAssess how the organization describes the products, materials or services that are purchased.

What does purchasing information include?

How do your purchasing personnel confirm that the purchase requirements




CONFORMING Y/N?


ITEMS NEEDED

are complete and correct before the order is placed?

Does the organization use purchase orders?

Do the purchase orders include information describing the product?

Do the P.O.’s include requirements for approval or qualifications (as appropriate) for approval of products, procedures, equipment and personnel?

Do the P.O.’s include quality management system requirements?

Does the purchasing process include an evaluation to ensure the adequacy of specified requirements prior to release?

7.4.3 Verification of Purchased ProductAssess how the organization has defined the inspection process for compliance and verify evidence of product acceptance. Verification of purchased product performed at the supplier’s premises is seldom used. If being done assess the process for compliance.

Is inspection used to verify that purchased product meets requirements?




CONFORMING Y/N?


ITEMS NEEDED

What other methods are used in addition to inspection?

Are the activities for verification of purchased product identified and implemented?

If the customer performs verification activities on the supplier’s premises, are the methods of verification and release specified?

Is there evidence that purchased product quality, delivery, or cost is affecting in-process, delivered product, and /or customer satisfaction/customer dissatisfaction?

7.4.3.1 Incoming Product Conformity to RequirementsDoes the organization have a process to assure the quality of purchased product utilizing one or more of the following methods:

- Receipt of, and evaluation of, statistical data by the organization?




CONFORMING Y/N?


ITEMS NEEDED

- Receiving inspection and/or testing such as sampling based on performance?

- Second or third party assessments or audits of supplier sites, when coupled with records of acceptable quality performance?

- Part evaluation by a designated laboratory?

- Another method agreed with the customer?

7.4.3.2 Supplier MonitoringDoes the supplier list include all products and services that affect customer requirements?

Does the organization monitor supplier performance through the following indicators:

- Delivered part quality performance?

- Customer disruptions including field




CONFORMING Y/N?


ITEMS NEEDED

returns?

- Delivery schedule performance (including incidents of premium freight)?

Does the organization promote supplier monitoring of their manufacturing processes’ performance?

7.5 Production and Service Provision7.5.1 Control of Production and Service ProvisionThe requirements noted below cover process control, inspection and testing, inspection and test status, and servicing and requirements for the release, delivery, and post-delivery of the product.

How are production and service provision controlled?

Where are the product characteristics documented?

How do personnel know what equipment to use for a process?

Does documentation identify what monitoring and measuring equipment should be used, and when?




CONFORMING Y/N?


ITEMS NEEDED

Select a representative sample of the processes of the organization.

Is there a quality plan or other document that identifies the characteristics controlled in each step of the process?

Is enough information available to specify the characteristics of the product?

Are work instructions available for each process step or are operators able to explain how to perform that step of the process? Is the equipment suitable for the work performed and do records show that maintenance is planned and being carried out?

Do they have the necessary gauge and/or monitoring equipment for process and product monitoring?

Do records indicate that the monitoring activities are properly implemented and that all persons operating the process are following it?




CONFORMING Y/N?


ITEMS NEEDED

Do they have defined processes for release, delivery and post-delivery activities?

Does the organization control the provision of product and service so that it is meeting or exceeding customer expectations?

Does monitoring and measurement data show that the organization is meeting objectives set for the product?

7.5.1.1 Control PlanDoes the organization:

- Develop control plans at the system, subsystem, component and/or material level, for the product supplied, including those for bulk materials produced by the organization and all purchased products and materials?

- Have a control plan for pre-launch and

production that take into account the




CONFORMING Y/N?


ITEMS NEEDED

design FMEA and manufacturing process FMEA outputs

Does the organization’s control plan:

- List the controls used for the manufacturing process control?

- Include methods for monitoring and recording results of control exercised over special characteristics defined by both the customer and the organization?

- Include the customer required information, if any?

- Initiate the specified reaction plan when the process becomes unstable or non capable?

Does the organization review and update control plans when any change occurs to affect product, manufacturing process, measurement, logistics, supply sources or FMEA?

7.5.1.2 Work Instructions




CONFORMING Y/N?


ITEMS NEEDED

Has the organization prepared documented work instructions for all employees having responsibilities for the operation of processes?

Are the organization’s work instructions accessible for use at the work-station?

Are the organization’s work instructions derived from sources such as the quality plan, the control plan and the product realization process?

7.5.1.3 Verification of Job Set-upsDoes the organization verify job set-ups whenever performed?

Are the organization’s work instructions available for set-up personnel?

Does the organization use statistical methods of verification of job set-ups where applicable?

7.5.1.4 Preventive and Predictive MaintenanceDoes the organization identify key process equipment and provide resources




CONFORMING Y/N?


ITEMS NEEDED

for machine/equipment maintenance and develop an effective planned total preventive maintenance system?

Does the organization’s preventive maintenance system, (at a minimum) include the following:

- Planned maintenance activities?

- Packaging and preservation of equipment, tooling and gauging?

- Availability of replacement parts for key manufacturing equipment?

- Documenting, evaluating and improving maintenance objectives?

Does the organization utilize predictive maintenance methods to continually improve the effectiveness of its preventive system?

7.5.1.5 Management of Production ToolingDoes the organization provide resources for tool and gauge design, fabrication and




CONFORMING Y/N?


ITEMS NEEDED

verification activities?

Does the organization establish and implement a system for tooling management including:

- Maintenance and repair facilities and personnel?

- Storage and recovery?

- Set-up?

- Tool-change programs for perishable tools?

- Tool design modification documentation, including engineering change level?

- Tooling identification defining the status?

Has the organization implemented a system to monitor its tooling management activities if any work is outsourced?




CONFORMING Y/N?


ITEMS NEEDED

7.5.1.6 Production SchedulingIs production scheduled in order to meet customer requirements?

Does it include just-in-time delivery and information systems that support an order driven system?

7.5.1.7 Feedback of Information from ServiceHas the organization established and maintained a process to communicate information on service concerns to manufacturing, engineering and design activities?

7.5.1.8 Service Agreement with CustomerWhen there is a servicing agreement with the customer, does the organization verify the effectiveness of:

- Any organization service centers?

- Special purpose tools or measurement equipment?

- Training of servicing personnel?




CONFORMING Y/N?


ITEMS NEEDED

7.5.2 Validation of Processes for Production and Service ProvisionIf special processes are part of your organization’s scope the above requirements will be assessed for compliance. Define conditions and the criteria for revalidation. If you have no special processes, identify that in the quality manual.

Does your organization have any processes for production and service where the output cannot be verified by monitoring or measurement?

Do you validate these processes?

How is validation performed?

If the process being audited is a special process, how is validation performed?

Does validation demonstrate the ability to achieve planned results?

Does the validation process include defined criteria for review and approval of the process?

Does the validation process include validation of processes?

Does the validation process include validation of equipment and personnel?




CONFORMING Y/N?


ITEMS NEEDED

Does the validation process include use of defined methodologies and procedures?

Does the validation process include requirements for records?

Does the validation process include Re-validation?

Does the organization validate all of its processes for all its production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement?

7.5.2.1 Validation of Processes for Production and Service Provision - supplementalDoes the organization apply the requirements for validation of processes to all processes for production and service provision?

7.5.3 Identification and TraceabilityProduct need to be identified in such a way as to know its status, that is, is good, bad, or don’t know?

How is product identified?




CONFORMING Y/N?


ITEMS NEEDED

How is measuring and monitoring status identified?

Does your organization control and record the unique identification of the product, where traceability is required?

Is the product identified throughout the process until it is shipped?

Is the identification clear and legible? Is each form or tag to be filled out completely?

Is the status of the product in relationship to measurement and monitoring clearly discernible?

How does the operator know what has and has not been checked?

To what level is traceability required?

How do they track the product to the traceability level required?

7.5.3.1 Identification and Traceability - supplemental




CONFORMING Y/N?


ITEMS NEEDED

Does the organization consider the above requirements of 7.5.3 as appropriate?

7.5.4 Customer PropertyProperty provided by the customer can include intellectual property, as well as tooling, information, software, containers, or materials. Remember to include all these items in the review of customer property.

Is there any customer property used in the process?

How is the customer property identified, verified, protected and maintained?

Do they have a process of recording and reporting to the customer any lost, damaged, or otherwise unsuitable product?

Is there evidence that this is happening?

7.5.4.1 Customer-Owned Production ToolingIs customer owned tooling permanently marked so that ownership of each item can be determined?

7.5.5 Preservation of ProductProducts need to be protected in order to preserve conformity to requirements




CONFORMING Y/N?


ITEMS NEEDED

How do you make sure that product quality is maintained during processing and delivery?

Is any product on the floor, misplaced, mishandled?

Are packaging specs defined and understood? Are they being followed?

Are there customer complaints related to improper packaging?

Are there customer complaints for damage products during transport?

Are there opportunities where something may go wrong?

7.5.5.1 Storage and InventoryIs the condition of product in stock verified periodically?

Ask the operator questions regarding identification, handling, packaging, storage, and protection to ensure proper




CONFORMING Y/N?


ITEMS NEEDED

controls are being followed.

Check inventory management system and inventory turns matrix.

Is FIFO being used to replenish inventory?

Is obsolete product controlled as if it were nonconforming?

Does the organization handle product in a fashion that ensures that the product is preserved?

Are constituent parts handled in a fashion that ensures that they are preserved?

7.6 Control of Monitoring and Measuring Equipment. Review procedures, work instructions and records for compliance.

Has your organization established a mechanism to ensure monitoring and measuring is performed consistent with requirements?

What action is taken if equipment is found to be out of calibration?




CONFORMING Y/N?


ITEMS NEEDED

Does your organization take appropriate action on the equipment and any product affected above?


How is software used for measuring and monitoring verified prior to use and reconfirmed as necessary?

Has the organization identified measurements to be made and the measurement and monitoring equipment required for conformity of product?

Audit the gages: (check quality, manufacturing prototype lab and maintenance department gages)

Accuracy, precision?

How chosen?

Identification?

Acceptance criteria?




CONFORMING Y/N?


ITEMS NEEDED

Handling, storage and preservation of inspection, measuring and test equipment?

Environmental conditions?

Location?

Corrective actions?

Frequency of checks?

Audit the calibration program.

NOTE: Monitoring and measuring equipment should be trailed from processes audited in Production and Service Provision (7.5)

Sample several pieces of equipment used in the organization for the following:

Are they calibrated to International or National Standards?

Are results recorded?




CONFORMING Y/N?


ITEMS NEEDED

Daily/weekly mastering of gages before use (usually during plant audit)?

Where no International Standard exists, is the basis of the calibration recorded?

Are they adjusted periodically or before use?

Is calibration status identified?

Are they safeguarded from adjustment that would invalidate the calibration?

Are they protected from damage and deterioration during handling, maintenance, and storage?

Does the organization have a process to re-assess previous results if equipment is found to be out of calibration and have corrective action taken?

What action is taken when equipment is found to be out of calibration?




CONFORMING Y/N?


ITEMS NEEDED

Audit backtracking of product when gage is found to be bad?

Have they recorded the results of calibration?

7.6.1 Measurement System AnalysisDoes organization conduct statistical studies to analyze the variation present in the results of each type of measuring and test equipment system?

Do the studies include GRR, bias linearity, stability and discrimination and test equipment?

Does the organization conduct measurement system analysis for measurement systems referenced in the control plan?

Does the organization use measurement system analytical methods and acceptance criteria that conform to those in customer reference manuals on measurement systems analysis?




CONFORMING Y/N?


ITEMS NEEDED

7.6.2 Calibration/Verification RecordsDo calibration records for organization and customer-owned gauges, measuring and test equipment include:

- Equipment identification, including the measurement standard against which the equipment is calibrated

- Revisions following engineering changes

- Any out-of-spec readings as received for calibration/verification

- An assessment of the impact of out-of-spec condition

- Statements of conformity to spec after calibration/verification

- Notification to the customer if suspect product or material has been shipped

7.6.3 Laboratory Requirements7.6.3.1 Internal Laboratory

If organization conducts in-house




CONFORMING Y/N?


ITEMS NEEDED

calibration, then they need to have a capable in-house laboratory that includes:

- Laboratory scope

- Adequate lab procedures

- Qualified laboratory personnel

- Evidence of proper testing

- Tests traceable to element standards

-A review of quality records

7.6.3.2 External LaboratoryIf outside laboratories are used, are the laboratories certified to ISO/IEC 17025.

Are the tests/calibrations performed included in the laboratory scope?

Is there evidence that the external lab is acceptable to the customer?

NOTE 1: Such evidence may be demonstrated by




CONFORMING Y/N?


ITEMS NEEDED

e.g. customer assessment, or by customer approved second party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.

NOTE 2: Where a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7.6.4.1 have been met.



8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

REQUIREMENTS

CURRENTLY IN PLACE(List documents or evidence)

CONFORMING Y/N?Estimated % Complete

ITEMS NEEDED8.1



General

Verify that your organization is monitoring, measuring, and improving the processes. How this is being done is defined by your organization. This may be written in procedures, although there is no requirement for this clause to have a procedure. Assess if your organization has determined the need for, and use of statistics.

How is product conformance demonstrated?

Is there a measuring and monitoring process in place?

How is the conformity of the QMS ensured?

Is there a measuring and monitoring process in place?

Does measuring and monitoring allow continual improvement of the effectiveness of the QMS?

Does the process include identification of methods, including statistical techniques for the measuring and monitoring?



Have measurement and monitoring activities been defined? What do they involve?

Have measurement and monitoring activities been planned?

How?

Have measurement activities been implemented?

Do they employ applicable methodologies?

8.1.1Identification of Statistical Tools



Do they employ applicable statistical techniques?

Are statistical techniques included in the control plan?

Have measurement and monitoring activities been defined? What do they involve?

Have measurement and monitoring activities been planned? Have statistical concepts been determined during Advanced Quality Planning?

8.1.2Knowledge of Basic Statistical Concepts

Are basic statistical concepts understood and used by the organization, such as variation, control (stability), process capability and over-adjustment?



Have measurement activities been implemented?

Do they employ applicable methodologies?

8.2Monitoring and Measurement

8.2.1Customer Satisfaction

This clause does not define how your organization is to monitor information on customer perceptions. For compliance to this clause, verify how your organization monitors the customer information, follow through on the methods being used. Are the methods being used consistent with the quality policy and quality objectives?

What methods does your organization use to monitor information on customer perception regarding fulfilling customer requirements?

Is there a defined process with documented methodologies for obtaining customer satisfaction and dissatisfaction?



Are all the types of customers surveyed / interviewed?

Is the number of customers surveyed/interviewed enough to provide good information, i.e. statistically valid?

Are they surveying/interviewing different departments within the customer who affect the buying decision?

How is this information used when determining customer expectations?

What is the quality of the information gathered? Is the information gathered useful in improving the organization?



Can they provide evidence of using this information for continual improvement?

Does the customer satisfaction process provide a true picture of the perception (opinion) of the organization’s customers? Is the information gathered useful in improving the organization?

Are the performance indicators headed in the right direction?

Does it show correlation to customer satisfaction?

Is the information gathered being used to improve customer satisfaction?

Is there an evaluation of the realization process indicators, in order to better understand the correlation between customer satisfaction and the product realization performance indicators?



Is the manufacturing process performance monitored?

Do trends show conformity with customer requirements?

8.2.1.1Customer Satisfaction - supplemental

Are the organization’s performance indicators for customer satisfaction based on objective data and include, but not be limited to:

- Delivered part quality performance?

- Customer disruptions including field returns?



- Delivery schedule performance (including incidents of premium freight)?

- Customer notifications related to quality or delivery issues?

8.2.2Internal Audit

A documented procedure is required for this clause. Assess the internal audit procedure for conformance to the requirements below. Verify the auditors have determined the QMS has been effectively implemented. It is management’s responsibility to make sure actions are taken in a timely manner.

Is an internal audit system in place?

Are they being performed on time?



Are they effective?

Do they identify good improvements and eliminate non-conformances?

How is the audit schedule prepared?

What measures are in place to ensure the audits and auditors are objective and impartial in the audit process?

Is there a documented procedure and does the procedure define the responsibilities and requirements for planning and conducting audits, including audit reports and maintaining records?

How does the management responsible for the area audited take timely action to eliminate nonconformities and their causes?



Do follow up activities include verification of the corrective action and the reporting of those results?

Is there an audit schedule that takes into account the status, importance of areas and activities, and the results of the previous audit?

Does the audit frequency change?

Do the records show that the schedule is being followed?

Does the internal audit cover the full scope of the standard as well as any customer specific requirements?

Do the audit schedule and the audit process indicate that the current auditing process audits effective implementation and maintenance of the system?



Have audits, scope and frequency, and methodologies been defined?

Are the auditors independent of the area audited?

Are audit questions comprehensive?

Are they focused on the performance of the process meeting planned objectives?

Is the objective evidence recorded for each question?

There should be objective evidence for both conformance and non-conformances.

Do the questions and the evidence indicate that the audit is checking whether the QMS is effectively implemented and maintained?



Are there non-conformances identified in the audit reports?

Are the non-conformances well written, that is, are requirement cited (is it correct); is there objective evidence, and the nature of the non-conformance?

Are all the elements audited?

If not, check to see that all the elements are audited by a combination of the entire year’s audits?

Are the nonconformities closed out in a timely manner?

Does the organization go back and audit the problem?



Is there objective evidence of verification results?

Is the internal audit generally finding the same type of problems as the current audit?

Are the problems well documented?

Is there objective evidence for areas of conformance and nonconformity?

Are the non-conformances closed out on a timely basis (three-month window at the most)?

Are the problems repeating?



Are the number and type of problems going down?

Are the summary results of the audits communicated to their respective process owners and Management?

8.2.2.1Quality Management System Audit

Is there evidence of QMS audits to IATF 16949:2016 and any additional requirements (e.g. customer-specific requirements, industry specific supplements)?

8.2.2.2Manufacturing Process Audit



Is there evidence of manufacturing process audits?

Are there corrective actions in the case the process audits yield non-conformances?

Does your customer require you to perform layered process audits? If so;

Is there evidence of layered process audit records?

Is there a layered process audit procedure?

Are there corrective actions for layered process audit non-conformances?



Is there evidence of manufacturing process audits?

8.2.2.3Product Audit

Is there evidence of product audits at different stages of production and delivery?

8.2.2.4Internal Audit Plans

Does the plan cover all quality management processes, activities and shifts?

Is the internal audit scheduled according to an annual plan?



Is audit frequency increased after internal/external nonconformities or customer complaints?

8.2.2.5Internal Auditor Qualification

Are there internal auditor training and qualification records?

Are the organization’s internal auditors qualified to audit the requirements of IATF 16949:2016?

Do the organization’s internal auditors meet the qualification requirements of your customer, if they are stated?

8.2.3



Monitoring and Measurement of Processes

Verify that your organization has defined and is performing the measuring and monitoring activities needed to confirm product conformity. Looking at the process data will provide evidence if process parameters or specifications have been identified. If not, was corrective action taken? Compliance would also include observing the measurement and monitoring processes.

How are QMS processes monitored? Where are appropriate measurements identified?

Are results evaluated to determine if the QMS processes are achieving the planned results?

When the results are not achieved, are corrective actions taken to confirm conformity of the product?

Are the policies, procedures or requirements (i.e. process characteristics) clearly identified?

Are the characteristics related to customer or product requirements for the processes identified?



What are the criteria and methods used to control the processes?

Are the methods suitable?

How do they ensure that the process is operating effectively and that the necessary resources and information are available to support operation and measurement of processes?

How are the processes measured, monitored and analyzed?

Is there evidence to show that the measurement and monitoring of the process is satisfactory in meeting customer requirements?



Are actions taken to achieve process goals and for continual improvement?

Do the criteria and methods used effectively control the process?

Are the process metrics related to customer requirements and organizational objectives?

Is the process improving and is it benefiting the customer?

8.2.3.1Monitoring and Measurement of Manufacturing Processes

Does the organization perform process studies to verify process capability and to provide additional input for process control?



Are there objectives for manufacturing process capability, reliability, maintainability, availability and acceptance criteria?

Is ongoing manufacturing process capability studied and improved per PPAP requirements.

Does the organization document the results of process studies with specifications where applicable for means of production, measurement and test, and maintenance instructions?

Is the control plan being followed?

Is the organization using the control plan reaction plan for unstable and non-capable processes?



Does the organization initiate the appropriate reaction plan from the control plan for characteristics that are either unstable or non-capable?

Does the organization’s reaction plans for characteristics that are either unstable or non-capable include containment of product and 100% inspection as appropriate?

Does the organization establish a corrective action following the initiation of reaction plans, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable?

Are the organization’s corrective action plans reviewed with and approved by the customer when so required?

Does the organization maintain records of effective dates of process changes?



Are there records for significant process events, such as tool change or machine repair?

8.2.4Monitoring and Measurement of Product

This section includes all measurement activities from receiving inspection to product delivery. Assess work instructions, procedures, and records to verify compliance. Verify that the records provide evidence that product criteria are met. Do the records also identify the person responsible for release?

Are the policies, procedures or requirements (i.e. process characteristics) clearly identified?

Are the characteristics related to customer or product requirements for the processes identified in General Requirements (4.1) and Planning of Product Realization (7.1)?

Is product measured and monitored to verify that product requirements are met?



Where are planned measurements identified?


Do they show conformance with acceptance criteria?

Who is authorized to release product? Is the appropriate person releasing product?

Is there evidence that product release and service delivery does not proceed until all activities have been completed (unless otherwise approved by a relevant authority or customer)?

What are the criteria and methods used to control the process?



Are the methods suitable?

How do they ensure that the process is operating effectively and that the necessary resources and information are available to support operation and measurement of processes?

How is the process measured, monitored and analyzed?

Is there evidence to show that the measurement and monitoring of the process is satisfactory in meeting customer requirements?

Are actions taken to achieve process goals and for continual improvement?

Do the criteria and methods used effectively control the process?



Are the process metrics related to customer requirements and organizational objectives?

Is the process improving and is it benefiting the customer?

8.2.4.1Layout Inspection and Functional Testing

Does the organization perform a layout inspection and a functional verification to applicable customer engineering material and performance standards for all products at a sufficient frequency as specified in the control plan?

Does the organization have layout inspection and functional testing results available for customer review?



Does customer require an annual layout inspection? If so, are records indicating annual layout inspection has been performed?

8.2.4.2Appearance Items

Sample products for appearance items, if applicable:

Is there appropriate lighting to perform appearance evaluations?

Are there masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) as appropriate? etc.

Is there maintenance/control of appearance masters and evaluation equipment?



What are the qualifications of personnel making appearance evaluation?

8.3Control of Nonconforming Product

A documented procedure is required for this clause. Verify the correction of nonconforming product and the re-verification by review of the records.

How has your organization ensured that product which does not conform to requirements is identified and controlled to prevent unintended use?

Is there a procedure that identifies responsibilities for taking action?

Does the procedure identify the ways that nonconforming product can be handled?




Is nonconforming product re-verified after correction to demonstrate conformity to requirements?

What action does your organization take when a nonconformity is detected after delivery or use has started?

Is there a documented procedure for dealing with nonconforming product?

Is the organization following the procedure?

Is non-conforming product (including product thought to be non-conforming) stored separately so that it does not get mixed with conforming product?



Does the organization promptly dispose of product that prevents a large accumulation of non-conforming product? Is there evidence of this?

How does the organization deal with non-conforming product?

Check log or file for deviation or concession records

Are records maintained of the nature of nonconformities and subsequent action?

What actions are taken if product non-conformance is discovered after shipping?

Are there customer complaints or rejects due to non-conforming product being shipped to customers?



Based on internal and external reject and rework data, are there problems indicated related to handling, packaging, storage and delivery?

8.3.1Control of Nonconforming Product -supplemental

Does the organization classify unidentified or suspect status product as nonconforming product?

8.3.2Control of Reworked Product

Are rework instructions available to personnel?

Is reworked product re-inspected per instructions?



8.3.3Customer Information

Is the customer informed promptly?

Is there evidence that the customers are informed promptly?

Are there requirements for reporting “rectification” of nonconforming product to the customer, end user, regulatory body, or other body?

Is it being done?

8.3.4Customer Waiver

Are concessions or deviations obtained from the customer if products or processes are different than those approved?



Waivers can be initiated by customer, supplier or the organization.

Do you see evidence of all three?

Is expiration date or quantity authorized recorded?

Is the temporary nature of deviation communicated to avoid confusion on plant floor?

How does compliance to expiration date or quantity occur?

Does material shipped documentation clearly identify deviation material?



Does the organization apply the customer waiver requirements for production product to purchased product as well?

Does the organization agree with any product concession requests from suppliers before submission to the customer?

8.4Analysis of Data

Assess the methods used to collect and analyze the data required below. Confirm the analysis of the data is used to demonstrate the suitability and effectiveness of the QMS and the system continues to improve.

How is data from measuring and monitoring activities used to demonstrate suitability and effectiveness of the QMS?

How is it used to continually improve the QMS?

Does the organization analyze data for improvement?

How often?



Does the data provide information on customer satisfaction and/or dissatisfaction?

Does the data presented clearly indicate the trend in customer satisfaction?

Is the data analyzed to understand things gone right or things gone wrong?

Does the organization trace success or failure to projects performing well or poorly?

Does the organization study opportunities for improvement and use techniques such as Pareto analysis or critical requests from customers to decide on new opportunities?



Does the organization analyze non-conformance data, customer complaints and customer returns?

Data analyzed should be collected to allow analysis of all customer requirements.

Is the data available in a form to allow analysis and identification of projects?

Is information on characteristics of processes, product and their trends analyzed?

Is process and product data tracked and trended?

What is the process when a process or product is found not meeting customer requirements?



Does the organization identify improvement opportunities for the characteristics?

Does the organization gather and analyzing information on suppliers?

Does the organization track supplier data as it relates to deliveries and receiving inspection?

Is this data used for selecting and evaluating suppliers?

How is the information used to identify improvement?

Does the data analysis clearly show what is happening to customer satisfaction, conformance to customer requirements, characteristics of processes, product and their trends, and suppliers?



Does the data point to improvement opportunities?

Does the organization determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made?

Does the organization’s data analysis include data generated as a result of monitoring and measurement and from other relevant sources?

Is data compared to competitors or benchmarks?

8.4.1Analysis and Use of Data



Check for characteristics of processes, product and their trends:

What do they do when a process or product is found not meeting customer requirements?

Is process and product data tracked and trended?

Do they identify improvement opportunities for the characteristics?

Is data compared to competitors or benchmarks?

Does the organization compare trends in quality and operational performance compared with progress toward objectives and lead to action to support the following:



- Development of priorities for prompt solutions to customer-related problems?

- Determination of key customer related trends and correlation to support status review, decision-making and longer term planning?

- An information system for the timely reporting of product information arising from usage?

8.5Improvement

8.5.1Continual Improvement

This clause contains many of the requirements already specified in previous clauses. Verify that the requirements are being used to plan for continual improvement.



How does your organization, continually improve the effectiveness of the QMS?

Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review?

8.5.1.1Continual Improvement of the Organization

Has the organization defined a process for continual improvement?

Are continuous improvement projects identified using the quality policy, objectives, audit results, analysis of data, corrective and preventive action, and management review?

Is there performance evidence?

How does the organization allocate resources to these projects?



What types of techniques are used for continuous improvement?

Is there evidence of improvement resulting from improvement project completion?

How are projects tracked and their completion?

Are improvement projects assigned to individuals and are deadlines established?

Are there projects for reduction of variation and waste in capable and stable manufacturing processes



Is there evidence of continual improvement?

Are the trends positive in performance measures related to quality objectives?

8.5.1.2Manufacturing Process Improvement

Does the organization’s continual improvement focus upon control and reduction of variation in products characteristics (special characteristics)?

Does the organization’s continual improvement focus upon control and reduction of variation manufacturing process parameters (process special characteristics)?

8.5.2



Corrective Action

A documented procedure is required for this clause. Review your records to confirm conformance.

What is identified as corrective action?

Are the actions taken appropriate to the impact of the problems encountered?

Is there a documented procedure for corrective action, and is there objective evidence that they follow it?

Sample several corrective actions:

Was the non-conformity (i.e. problem) identified?



Was the cause of non-conformity determined?

Was the need for actions to ensure problem do not repeat evaluated?

Was corrective action implemented?

Were results of the corrective action recorded?

Was the corrective action taken?

Does the data show that the corrective action is effective?



Do problems repeat?

Are corrective action performance trends monitored, analyzed and improved?

8.5.2.1Problem Solving

Does the established problem solving process include root cause identification and elimination?

If required, do they follow the customer prescribed problem-solving format?



8.5.2.2Error-Proofing

Are error-proofing methods used?

Do FMEA’s demonstrate greater implementation of prevention controls rather than only detection controls?

Do error-proofing methods implemented in corrective action initiate changes to the PFMEA and Control Plan?

Check for linkage.

8.5.2.3Corrective Action Impact

Was the corrective action applied to similar processes and products?



8.5.2.4Rejected Product Test/Analysis

Does the organization analyze parts rejected by the customer's manufacturing plants, engineering facilities, and dealerships?

Does the organization minimize the cycle time of its rejected product test/analysis process?

Does the organization keep records of its rejected product test/analyses and make available upon request?

Does the organization perform analysis and, initiate corrective action to prevent recurrence?

8.5.3



Preventive Action

A documented procedure is required by this clause. Review records to confirm conformance.

Has your organization established a procedure to eliminate the cause of potential nonconformities to prevent their occurrence?

Is there objective evidence it is followed?

What does the organization identify as preventive action?

Are the actions taken appropriate to the impact of the problems encountered?

Sample preventive actions:

Was a potential non-conformity (i.e. problem) identified?



Was it determined that preventive action was needed?

Were the results of action taken recorded?

Was preventive action taken reviewed?

Does the data show that the preventative action is effective?

Are problems eliminated before they occur?



Additional Notes:

Additional Notes:


The Gap Analysis Checklist - MinthAmericas - Home€¦ · Web viewIATF 16949:2016 Gap Analysis...

Documents

Transcript of The Gap Analysis Checklist - MinthAmericas - Home€¦ · Web viewIATF 16949:2016 Gap Analysis...