Professional Machine and Tool

Professional Machine and Tool

QUALITY MANUAL Rev. G

Issue Date: 11/16/09

President: Marc Stearman

Signature: Signature on the hard-copy

Date 11/16/09

Quality Manual, Rev. G of 32

REVISION HISTORY

Revision Description Date

A Refer to Quality Manual, Revision C, maintained as obsolete (scan) 5/15/02

B Refer to Quality Manual, Revision C, maintained as obsolete (scan) 9/19/02

C Refer to Quality Manual, Revision C, maintained as obsolete (scan) 1/31/05

D Re-issue manual per AS9100, Revision B 7/1/09

E 7.5.1.2 Change description of process change 10/5/09

F 1.2 Clarify exclusion of servicing for sections 7.5.1 and 7.5.2 10/22/09

F 4.2.3 revise obsolete documents control 10/22/09

F 7.2.2 Change contract review to QC manager from President 10/22/09

F 4.1 Add more specifics to outsourced processes 10/22/09

F 4.3 Add more specifics to configuration Management 10/22/09

F 7.4.1 Change supplier approval/disapproval to President OR QC Manager 10/22/09

F 8.3 Remove President from the process for control of nonconforming product 10/22/09

G 4.2.3 Delete forms from controlled documents 11/16/09


Quality Manual Table of Contents Revision History 2 Table of Contents 3 1. SCOPE 5 1.1 General 5 1.2 Application 5 2. REFERENCE 5 3. TERMS AND DEFINITIONS 5 4. QUALITY MANAGEMENT SYSTEM 6 4.1 General Requirements 6

4.2 Documentation Requirements 6

4.2.1 General 6

4.2.2 Quality Manual 7

4.2.3 Control of Documents 7

4.2.4 Control of Records 9

4.3 Configuration Management 9 5. MANAGEMENT RESPONSIBILITY. 11 5.1 Management Commitment 11

5.2 Customer Focus. 11

5.3 Quality Policy 11

5.4 Planning 11

5.4.1 Quality Objectives 11

5.4.2 Quality Management System Planning 12

5.5 Responsibility, Authority and Communication 12

5.5.1 Responsibility and Authority 12

5.5.2 Management Representative . 12

5.5.3 Internal Communication . 12

5.6 Management Review 12

5.6.1 General 12

5.6.2 Review Input 13

5.6.3 Review Output 13 6. RESOURCE MANAGEMENT 14 6.1 Provision of Resources 14

6.2 Human Resources 14

6.2.1 General 14

6.2.2 Competence, Awareness and Training 14

6.3 Infrastructure 14

6.4 Work Environment 15 7. PRODUCT REALIZATION 16 7.1 Planning of Product Realization 16

7.2 Customer-Related Processes 16

7.2.1 Determination of Requirements Related to the Product. 16

7.2.2 Review of Requirements Related to the Product . 16

7.2.3 Customer Communication 17


7.3 Design and Development. 17 7.4 Purchasing 17

7.4.1 Purchasing Process 17

7.4.2 Purchasing Information 18

7.4.3 Verification of Purchased Product 19 7.5 Production and Service Provision 20

7.5.1 Control of Production and Service Provision 20

7.5.1.1 Production Documentation. 20

7.5.1.2 Control of Production Process Changes 21 7.5.1.3 Control of Production Equipment, Tools and Numerical Control (NC) Machine Programs 21 7.5.1.4 Control of Work Transferred, on a Temporary Basis, Outside the Organization’s Facilities . 21

7.5.1.5 Control of Service Operations 21 7.5.2 Validation of Processes for Production and Service Provision 22

7.5.3 Identification and Traceability. 22

7.5.4 Customer Property . 23

7.5.5 Preservation of Product 23

7.6 Control of Monitoring and Measuring Devices 23 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT 25 8.1 General 25

8.2 Monitoring and Measurement 25

8.2.1 Customer Satisfaction 25

8.2.2 Internal Audit 27

8.2.3 Monitoring and Measurement of Processes. 27

8.2.4 Monitoring and Measurement of Product . 27

8.2.4.1 Inspection Documentation 28

8.2.4.2 First Article Inspection 28

8.3 Control of Nonconforming Product 28

8.4 Analysis of Data 30

8.5 Improvement 30

8.5.1 Continual Improvement 30

8.5.2 Corrective Action 30 8.5.3 Preventive Action 31


1. Scope

1.1 General This manual contains the policies, procedures and references necessary to describe the quality management system implemented by Professional Machine & Tool, for the purpose of customer satisfaction and continual improvement of business processes related to product quality. Professional Machine & Tool provides precision-machined parts and components for the aerospace industry. These parts and components demand a high level of competence and technical knowledge, and involve mutually beneficial supplier relationships to ensure the desired outcome for customers of Professional Machine & Tool.

1.2 Application This system is designed to reflect the requirements of both the international standard, ISO 9001:2008 and the aerospace industry standard, AS9100, Rev. B., and incorporate the clauses necessary to support both internal and customer objectives. Professional Machine & Tool takes exclusion to the following:

Design activities as listed in paragraph 7.3, Product Design, since the company performs no design activities for customers.

Post-delivery activities (servicing), as listed in both 7.5.1 and 7.5.2 since this is not performed by the company.

2.0 MANUAL REFERENCE

The basic requirements for the Professional Machine & Tool quality management system are found in the current revision of the standards ISO 9001:2008 and AS9100, Revision B. 3.0 TERMS AND DEFINITIONS

QMS Quality Management System MR Management Representative PMT Professional Machine & Tool


4.0 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements The PMT quality processes are shown in the Quality Management System Processes flowchart. It shows the order and interaction of the company’s general processes. The order and interaction of specific (department, machine, or product) quality management system processes can be found on a Shop Order, work instructions, specifications, drawings or flow charts associated with them. The criteria and methods for effective control of processes are found in internal audit procedures, inspection instructions and work instructions. The upper management in conjunction with staff enables the availability of necessary resources. The information necessary for effective operation and monitoring of these processes is found within available controlled documents throughout the operation. Upon the completion of measurement and monitoring of the processes and analysis of the data, appropriate action is taken to assure intentions are achieved and opportunities for improvement are implemented. Management of these processes is accomplished in accordance with the requirements of ISO 9001:2008 and AS9100, revision B. Outsourced processes, having impact on the conformity of product requirements are controlled. This may involve qualification of the processor, providing specific processing requirements, including process verification (certificate of compliance) as appropriate. Management of these processes is accomplished in accordance with the requirements of ISO 9001:2008 and AS9100, B. Outsourced processes, having impact on the conformity of product requirements are controlled. These processes, and their control, include:

Metal finishing – Purchase Order requirements, applicable specification(s), review of certificates and receiving inspection.

Heat treat – Purchase Order requirements, applicable specification(s), review of certificates and receiving inspection. Possible hardness checks if not detrimental to the product.

NDI – Purchase Order requirements, applicable specification(s), review of certificates and receiving inspection.

Calibration – Purchase Order requirements, tolerance requirements, if applicable, and review of certificates.

Internal Quality Audits (Use of Q Corporation internal audit forms, specified audit criteria and review of audits upon completion)

4.2 DOCUMENTATION REQUIREMENTS 4.2.1 General The company has the following documentation to support their quality management system:


Quality policy statement and quality objectives

Quality Manual

Procedures as addressed in this manual that are required by the standards

Quality Management System requirements imposed by customer and/or regulatory authorities

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

Records required by the standards PMT ensures that personnel have access to Quality Management System documentation and are aware of procedures that apply to their responsibilities. Customers or their representatives have access to agreed portions of the Quality Management System documentation and records. 4.2.2 Quality Manual The company has established this quality manual to address the requirements of AS9100, Revision B, and ISO 9001:2008. This quality manual contains a scope with exclusions, procedures and makes reference to other separate procedures, if applicable. 4.2.3 Control of Documents PMT controls all documents that are required by the Quality Management System. Where required by customer contracts, the Quality Control Manager will coordinate any needed document changes. The control system includes internal, as well as external, documents that require identification and controlled distribution.

The document control process addresses:

document approval prior to initial issuance; Quality Manual, procedures, work instructions Review by management Signature and date of approver on the cover page of the document. Add document to Master List of Controlled Documents. Determine distribution and enter on the master list.

Shop Order Release by QC Manager or President when all requirements verified. Shop Order for expediting an order is completed by handwriting the process

and approved by the Quality Manager or President. Documents of external origin (prints, drawings, etc.) Review by President (stamp, initials or signature) prior to release of Shop

Order to the shop Programs and other electronic documents/data Provided to and/or developed by the Programmer


Saved on Server Back-ups of server performed as necessary

the review, revision and re-approval of controlled documents; Quality Manual, procedures, work instructions Revised document created with new revision, revision history updated Refer to the Master List of Controlled Documents for approver Signature and date of the approver on the cover page of the document Issue new document as required by distribution (refer to Master List of

Controlled Documents) Destroy old revisions/copies

Shop Order Changes made by QC Manager or President as required

Documents of external origin Review by President (stamp, initials or stamp) prior to release of Shop Order

to the shop Update review by QC Manager prior to availability

Programs and other electronic documents/data Changes provided to and/or developed by the Programmer Replace old revision, if applicable Saved on Server Back-ups of server performed as necessary

identification of changes and current revision status; Quality Manual, procedures, work instructions – Revision on the first page with

revision history updated Documents of external origin – dependent on the information and revision of the

issuing organization. Electronic media – identified within the media

distribution of controlled documents to the appropriate point-of-use; Quality Manual, procedures and work instructions, distribution is based on the

information in the Master List of Controlled Documents. If document is the Shop Order, distribution is to Production and filed when

complete. Electronic media is distributed to Production equipment as required.

maintenance of legibility and identification of documents QC Manager is responsible for maintaining legibility and identification of

documents documents must have identification prior to issue documents are protected for preservation, if possible, based on the location of

the document. QC Manager reviews document identification and legibility by casual review

within the facilities or part of an internal audit related to document control.


the identification and retention of obsolete documents Documents, such as prints and other customer-provided documents used on an

order are not considered obsolete as long as there are parts in the facilities that the print refers to.

If an obsolete document is maintained, the QC Manager is informed. The document is filed and controlled by the QC Manager. If a hard-copy document, the word “obsolete” is written on the document so that it

is readily seen and placed in a file called “Obsolete Documents”. If an electronic file, it is placed in a folder marked “Obsolete Documents” that cannot be accessed by any other employee.

At each management review meeting, an agenda item will be obsolete documents review.

If no longer needed, the document is shredded or deleted. Any document changes that affect contractual arrangements are coordinated with the appropriate customer or regulatory authority by the President or the QC Manager.

4.2.4 Control of records Records are established to show conformance to the customer requirements and the effective operation of the Quality Management System. All data supporting the achievement of requirements and effectiveness of the quality system are included as records. Where required by customer contracts or regulatory authorities, the QC Manager will coordinate access to records. Specific records have been identified as required to be kept. Basic procedure for control of records is as follows:

Records must be legible

Records must be identifiable as to what they pertain to

Records must be maintained so as to protect them from damage or deterioration. Control requirements for quality records are shown in the Quality System Records Control matrix available on the Quality computer. The matrix addresses the requirements as follows:

Identification,

storage,

protection,

retrieval,

minimum retention time, and

disposition method when the retention time is expired A customer or regulatory agency may specify the minimum retention time for records. Records that are required of suppliers are controlled by the company’s Terms and Conditions document as follows: 4.3 Configuration Management.


Configuration management at Professional Machine & Tool is maintained in conjunction with customer requirements. As part of contract review activities (customer purchase document or on-line access) the parts are reviewed and coordinated with the customer, as required. If a revised part configuration is such that it may not be used to replace the current part then the customer is advised as to the configuration change point, current production and stock status, if any. Production records are maintained as records of the configuration. Lots or batches of materials used in production provide traceability to product, as well as configuration information as applicable. Configuration management may be controlled per the following sections as each applies to the controls required:

5.2, Customer Focus for commitment to requirements

7.1, Planning for Product Realization to assure that requirements are understood during the quote process

7.2.2, Review of requirements related to the product at the time of contract review

7.5.3, Identification and Traceability that assures configuration is maintained

4.2.3, Document Control which provides for current revision of a print or other customer document.

7.5, Production documentation, Shop Orders


5.0 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment PMT uses the following to display their commitment to continual improvement and to its customers:

Communication about the importance of fulfilling customer legal and regulatory requirements occurs throughout the company. That communication happens through the use of: General and product specific information Training as appropriate Periodic communication meetings

Specific emphasis in provided documentation: The quality policy The quality objectives The management review records

Availability of resources needed to support the quality management system 5.2 Customer Focus Management assures that all customer requirements will be determined through PMT processes beginning with planning and quote development. Through policies, objectives and processes, management assures the needed environment to meet customer requirements. By routinely assessing customer satisfaction, management optimizes customer satisfaction. Information will be shared in a timely manner concerning issues with customers. This is intended to help keep employees focused on customer satisfaction. 5.3 Quality Policy The Quality Policy statement was developed by management and provides a framework for the defined objectives of PMT. The policy describes the company’s commitment to meet the requirements of the Quality Management System and to promote its ongoing improvement. Management communicates the policy and its meaning to all employees through orientation and training, meetings and posted statements throughout the facility. Refer to the Quality Policy statement. After communication of the quality policy to employees, they are expected to understand the policy and know what it means to them in their job. Uncontrolled copies of the policy will be posted in the facility to encourage employees to fulfill the requirements of this policy in their work related efforts and decisions. The quality policy is reviewed at least annually as part of Management Review meetings. 5.4 PLANNING 5.4.1 Quality objectives


Management has established quality objectives, which are measurable and consistent with the Quality Policy. These objectives are reviewed as a part of Management Review, as required. Refer to the Quality Objectives. 5.4.2 Quality management system planning Management is responsible for quality management system planning. This occurs in the quoting process informally and in the Management Review meetings. When changes occur in organization, equipment, processes or the overall quality management system itself, management acts as required to assure these actions are compatible with maintaining the integrity of the quality management system. 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 5.5.1 Responsibility and authority The Quality System Processes flowchart, the company Organization Chart and the Authority Matrix show functions, interrelations, responsibilities and authorities relevant to the quality management system. Additional responsibilities and authorities may be found on job descriptions, Shop Order, flow charts, work instructions etc. Availability of this information helps to assure clear communication to personnel. 5.5.2 Management representative The QC Manager has been appointed by the President to serve as Management Representative. The assigned duties include:

Overseeing the implementation and maintenance of the quality system in accordance with ISO9001:2008 and AS9100, Revision B, requirements.

Reporting on the performance of the quality management system to management.

Reporting on the need for improvement of the quality management system to management.

Encouraging and assisting in extending the understanding of customer requirements throughout PMT.

Acting as the contact between registration organizations and PMT. The QC Manager has the organizational freedom to resolve matters pertaining to quality. 5.5.3 Internal communication Information is shared with personnel to provide insight into the performance of the quality management system. This is done as needed by one-on-one or group communication. Email can be used if available to the employee. Employees will be made aware of corrective and preventive actions including customer complaints as appropriate. 5.6 MANAGEMENT REVIEW 5.6.1 General


In order to assure the continuing suitability, adequacy and effectiveness, management will conduct reviews of the quality management system. This will be done no less frequently than annually. Other meetings may be held as necessary. The reviews can address the Quality Management System in it’s entirely or in parts, as long as the entire quality management system is reviewed during each calendar year. Management Review minutes are maintained per the requirements of the Quality System Records Control matrix. The agenda for the meetings will be the same for each session. Sections 5.6.2 (Review Input) and 5.6.3 (Review Output) make up the standard agenda items for the meetings. If anyone is to bring information to share at these meetings, they will be informed by the President or the Management Representative. Outputs (action items) are recorded in the minutes and controlled by the Preventive Action process. 5.6.2 Review input

audit results (internal and external)

customer feedback (including complaints), customer perception

process performance and product conformity

status of preventative and corrective actions

follow-up actions from previous management reviews

changes that could affect the quality management system

recommendations for improvement

review of quality policy and objectives

re-valuation of suppliers (once per year)

review of obsolete document retention (once per year) 5.6.3 Review output

improving the effectiveness of the processes in the quality management system

overall improvement of the quality management system effectiveness

improvements upon product associated with customer requirements

maintenance of appropriate resources


6.0 RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES Resources for the following purpose are provided on time:

to implement and maintain the quality management system

to continually improve upon the quality management system effectiveness

to ensure customer satisfaction through consistent achievement of customer requirements

6.2 HUMAN RESOURCES 6.2.1 General Personnel performing work at PMT that affects product quality shall be competent on the basis of appropriate education, training, skills and experience. This is listed in the Job Descriptions found in the Training Records file on the Quality computer. 6.2.2 Competence, Awareness and Training PMT management determines the competence, awareness and training associated with each job within the company and takes action to eliminate any discrepancies. This is done per the following:

determine the necessary competence for personnel performing work affecting product quality,

provide training or take other actions to satisfy these needs,

evaluate the effectiveness of these actions taken,

ensure that its personnel are aware of the relevance and importance of their activities and show how they contribute to the achievement of the quality objectives

Maintain job descriptions and training history as appropriate records of education, training, skill and experience.

This training will continue until management is content that each employee knows and understands the Importance and the relevance that their competence gives to PMT. When it is necessary, actions other than training will be used to achieve the needed competence and appropriate effectiveness. The QC Manager is responsible for keeping records of education, certification, training, skills and experience. 6.3 INFRASTRUCTURE Top management determines the infrastructure needs for each new product or significant change to existing product. Consideration is given to the following:

Building - size, location

Workspace - size, layout

Facilities associated with building or workspace – HVAC, water, lighting, electricity, telephone systems, and data lines, compressed air lines, vacuum lines, and machine specific requirements


Equipment (hardware) – furniture, workbenches, storage racks, tools, gages, machines test equipment, vehicles, computers, other office equipment

Equipment (software) – MRP, CAD, process control, test, calibration, data collection, SPC

Services for support preventive maintenance, calibration, engineering, transportation, and emergency.

6.4 WORK ENVIRONMENT PMT provides the work environment needed to achieve conformity to product requirements. This may include control of temperature, humidity, lighting and cleanliness. Quality system audits provide feedback to management on work environment issues.


7.0 PRODUCT REALIZATION 7.1 PLANNING OF PRODUCT REALIZATION PMT has developed a basic plan for processes needed for product realization. The company knows its capabilities and plans accordingly. Planning for product realization is in place with the equipment that is available, inspection capability and trained workforce. More specific planning is performed when a request for quote is received. The company realizes that each product will require different materials, machining, set-up, inspection and delivery. This method of planning is consistent with the requirements of the other processes of the Quality Management System. PMT plans product realization after receiving a request for quote. This takes into account the following items as appropriate:

quality objectives and requirements for the product;

the need to establish processes, documents, and provide resources specific to the product;

required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;

records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4);

the identification of resources to support production of the product A Shop Order developed as a result of planning is not issued unless the job is won by the company. 7.2 CUSTOMER RELATED PROCESSES 7.2.1 Determination of requirements related to the product In an effort to thoroughly identify all customer requirements, the following are considered by management as they interface with the customer and as product development takes place:

requirements specified by the customer, including the requirements for delivery and post-delivery activities,

requirements not stated by the customer but necessary for specified or intended use, where known,

statutory and regulatory requirements related to the product, and

any additional requirements determined by the organization. This process may result in a quote. 7.2.2 Review of requirements related to the product PMT reviews requirements related to the product at the time an order (including a verbal order) is received by the company. This review is conducted prior to PMT’s acceptance of the order. The company makes no commitment to supply a product to the customer until all quotes, contracts/orders, including changes made, are reviewed to ensure that: a. product requirements are defined, b. any contract or order requirements differing from those previously expressed are

resolved,


c. that PMT has the ability to meet the defined requirements, and that d. risks due to new technology, new processes or short delivery times are evaluated Records of the review of requirements and follow-up actions are maintained. The QC Manager shows review and approval by initials, signature or stamp along with the date of review and approval. Minor tasks, especially expedited jobs, may be accepted and performed using a handwritten Shop Order stamped, signed or initialed by the President or Quality Manager. This ensures that product requirements are documented. If product requirements are changed, PMT ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements. This usually results in a change to the Shop Order, whether it is re-issued or revised in writing, signed and dated. The order from the customer is revised, signed and dated. The customer may wish to send another order (change order) revised as required. All customer orders and related records from contract review constitute the controlled records for the process. Notes may be attached to these records as required. 7.2.3 Customer communication PMT determines and implements effective arrangements for communication with customers in relation to product information, enquiries, contracts (including amendments) and customer feedback (including customer complaints). Random verbal or email contact may be performed to get information related to satisfactory completion of any corrective action, etc. 7.3 DESIGN AND DEVELOPMENT PMT does not design products. All products are manufactured to customer designs. 7.4 PURCHASING 7.4.1 Purchasing process Management has primary responsibility for dealing with suppliers of products used in the manufacturing process by PMT. The company locates, develops and authorizes suitable suppliers capable of providing PMT with materials that conform to specific requirements. PMT:

maintains approved suppliers in the Approved vendors List. This includes the scope of approval. The President or the QC Manager have responsibility for approving supplier quality systems and have the authority to disapprove the use of sources.

continually reviews supplier performance with each order received (quality, on-time delivery, price) and re-evaluates them at one Management Review per year. This determines controls on the supplier or maintenance of the supplier as approved. Suppliers that do not meet the requirements are warned either by email or by a corrective action request. Failure to respond in a timely manner to a concern may


justify removal from approved status. The President or QC Manager make the final decision.

ensures where required that both PMT and all suppliers use customer-approved special process sources.

Supplier approval may be based on the following, as applicable:

The quality of the suppliers product/service and/or delivery capabilities

Value

Required to complete an order from a customer After a potential supplier is determined to be suitable by the President and/or the QC Manager, they will be added to PMT’s Approved Vendors List. The date of the approval is the new date for the approved list. This is the record of approval. The application of the above process is dependent on the impact of the purchased material on the product and/or service to be purchased. PMT is responsible for the quality of all products purchased from suppliers, including any customer-designated sources. The company ensures that where required, it and its suppliers use customer-approved special process sources. 7.4.2 Purchasing information PMT purchase documents (or referenced attachments) and/or the Quality System Requirements document will include, where applicable:

requirements for approval of product, procedures, processes and equipment,

requirements for qualification of personnel,

quality management system requirements, the name or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data,

requirements for test, examination, inspection and related instructions for acceptance by PMT,

requirements for test specimens (such as production method, number, storage conditions) for design approval, inspection, investigation or auditing

requirements relative to supplier notification of nonconforming product and arrangements for PMT approval of supplier nonconforming material,

requirements for the supplier to notify PMT of changes in product and/or process definition and, where required, obtain PMT approval,

right of access by PMT the customer of PMT and regulatory authorities to all facilities involved in the order and to all applicable records

requirements for the supplier to flow down to sub-tier suppliers applicable requirements in the purchasing documents, including key characteristics where required

A new Quality System Requirements document will be sent to suppliers if there is any change to be communicated. New suppliers will be given a copy of the Quality System Requirements when they become affiliated with PMT.


PMT ensures the adequacy of specified purchase requirements prior to their communication to the supplier. This is done on the Purchase Order as the person making the purchase signs or initials or stamps the form with the date of review and approval. When outside processing is required, the Shop Order is used to track shipping and receiving. 7.4.3 Verification of purchased product PMT has established and implemented inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Received material or product is tracked on the Shop Order. PMT verification activities may include obtaining objective evidence of the quality of the product from suppliers including:

accompanying documentation, certificate of compliance/conformity/analysis (as required), test reports, statistical records, and/or process control records

inspection and audit at supplier’s premises,

review of the required documentation, and/or

inspection of products upon receipt Purchased product should not be used or processed until it has been verified as conforming in accordance with the plan for the product. In case It needs to be released without verification, it is released as follows:

Positive recall requires the approval of the management.

The product is marked as not verified, and

the lot number of the material, as well as “not verified”, is noted on the Shop Order Where PMT utilizes test reports to verify purchased raw material, the data in those reports must be acceptable per applicable specifications. PMT will send a sample of material annually. This will validate for contents and to receive a test report to compare with the supplier’s report. Record of any validation is the test lab’s report and a copy of the supplier’s certificate. The QC Manager can request to have raw material validated at any time. PMT does not delegate verification activities to a supplier. If work is outsourced, it is inspected upon receipt. Where PMT or a customer (when specified in the contract) intends to perform verification at the supplier's premises, these verification arrangements and the method of product release is contained in the purchasing information. A Purchase Order will be used to specify the on-site visit and the QC Manager will coordinate the details and maintain communication with all parties involved. An inspection form may be used to record the visit or it can be recorded on a copy of the PO.


Verification by the customer is not used by PMT as evidence of effective control of quality by the supplier and shall not absolve PMT of the responsibility to provide acceptable product. It does not preclude subsequent rejection by the customer. 7.5 PRODUCTION AND SERVICE PROVISION 7.5.1 Control of production provision (service provision does not apply to PMT) Review of the Shop Order takes into consideration the following: Since product planning has occurred prior to quoting and order acceptance, a large part of the planning to manufacture of product has been completed.

the identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of realization,

the design, manufacture (or purchase), and use of tooling so that variable measurements can be taken, particularly for key characteristics,

the establishment of process controls and development of control plans where key characteristics have been identified,

the qualification of operators or monitoring of special processes, where results cannot be confirmed by direct inspection or test

PMT plans and carries out production in accordance with the applicable procedures and in sequence with operations on the Shop Order. Production controlled conditions include, as applicable the: a) availability of information that describes the characteristics of the product (Shop

Order and Print, if applicable), b) availability of work instructions, as necessary, c) use of suitable equipment (determined during product planning), d) availability and use of monitoring and measuring devices (determined during product

planning), e) implementation of monitoring and measurement activities (as directed by the Shop

Order), f) implementation of release and delivery activities (if different than normal Shop Order

sign-off and if special requirements are made by the customer), g) accountability for all product during manufacture (such as part quantities, split

orders, and nonconforming product), h) evidence that all manufacturing and inspection operations have been completed as

planned on the Shop Order, or as otherwise documented and authorized (signature, initials or stamp on the Shop Order),

i) provision for the prevention, detection, and removal of foreign objects (instruction given to all employees),

j) monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product quality, and

k) criteria for workmanship, which can be described by supervision, prints/drawings, representative samples or illustrations

7.5.1.1 Production Documentation


Production operations are carried out in accordance with approved documentation/data. This documentation/data includes, as necessary:

drawings, parts lists, process flow charts including inspection operations, production documents, including the Shop Order and it's attachments and inspection documents (if any),

a listing, or identification, of specific or non-specific tools and/or computer numerical control (CNC) machine programs required and any specific instructions associated with their use

7.5.1.2 Control of Production Process Changes The President, Production Manager or QC Manager are authorized to approve changes to production processes/Shop Order. The company gets approval from the customer if required by the customer’s order or contract. Changes affecting processes, production equipment, tools and programs are documented. The procedure for making changes is as follows:

An operator or employee may request that a change be made.

An authorized person will review the request and determine if the change is acceptable.

If the change is made it will be crossed out with a single line and initialed on all copies of the Shop Order or related documents.

The Shop Order will be revised, reviewed and re-issued to production with the required changes.

The QC Manager or the operator confirms that the desired effect has been achieved without adverse effects to product quality. 7.5.1.3 Control of Production Equipment, Tools and Computer Numerical Control (C.N.C.) Machine Programs Equipment and tools are validated prior to use and re-validated as required. Programs are verified prior to production use by the Programmer. First article Inspection will validate the program against customer requirements. Preventive maintenance is performed for each machine as follows:

A visual inspection may be made to note any thing that needs attention.

The Preventive Maintenance Record (with preventive maintenance listed) is completed with any action taken.

The form is kept at each machine. Storage requirements, including preservation and condition check, will be done for production equipment or tooling in storage. Operators will inspect tooling prior to use. 7.5.1.4 Control of Work Transferred, on a Temporary Basis, Outside of the PMT Facility If PMT plans to temporarily transfer work to a location outside of the facility, then PMT will define the process to control and validate the quality of the work. This is done on the Purchase Order that communicates the work to be done by the designated supplier.


Upon receipt of the product from the supplier, inspection will be performed as directed by management or the QC Manager. 7.5.1.5 Control of Service Operations PMT does not provide servicing or work in a customer’s facility. 7.5.2 Validation of Processes for Production Provision PMT validates any processes for production provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. PMT validates processing performed as outsource by review of the certificate provided with the processed parts. As applicable, PMT will establish procedures and requirements for these processes including, as applicable:

defined criteria for review and approval of the processes,

approval of equipment and qualification of personnel,

use of specific methods and procedures,

requirements for records (see 4.2.4), and

revalidation. 7.5.3 Identification and Traceability Where practical PMT identifies the product by markings applied to the product, tag or container. During the manufacturing process the product is also identified by the Shop Order accompanying the product. PMT maintains the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration. PMT also provides identification or other suitable marking to show the product status with respect to completion of monitoring and measurement requirements (inspection). When stamps, signatures or initials are used to indicate acceptance authority, PMT indicates that approved authority on the Authority Matrix, which is maintained as a controlled document. No stamp may be re-issued for a period of at least one-year after that media has been cancelled or revoked. The QC Manager controls the issuance of stamps. Where traceability is a requirement, PMT controls and records the unique identification of the product lot as a quality record.


According to the level of traceability required by contract, regulatory, or other established requirement, the PMT QMS provides for:

identification maintained throughout the production and delivery;

all the products manufactured from the same lot of raw material or from the same manufacturing batch to be traced, as well as their destination;

for an assembly, the identity of its components and those of the next higher assembly to be traced;

for a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved

7.5.4 Customer property PMT exercises care with customer property (including intellectual property – customer-furnished data used for production and inspection) while it is under company control or being used by us.

PMT identifies customer property when received on the Purchase Order from the customer. The Shop Order lists the material or tooling as customer owned.

The product is verified as required when received, usually identification, quantity and condition.

Adequate protection is provided to safeguard customer property provided for use or incorporation into the product.

When used and returned to the customer, the ship date is noted on the Shop Order.

If any customer property is lost, damaged or otherwise found to be unsuitable for use, it will be reported to the customer and quality records will be maintained.

Prints and other information and data files are kept on the company server. Refer to 4.2.3. 7.5.5 Preservation of product PMT preserves the conformity of product during internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection. Preservation also applies, if appropriate, to the component parts of a product. PMT ensures that documents required by the order to accompany the product are present at delivery and are protected against loss and deterioration. Preservation of product includes, where applicable provisions for:

cleaning;

prevention, detection and removal of foreign objects;

special handling for sensitive products;

marking and labeling including safety warnings;

shelf life control and stock rotation;

special handling for hazardous materials 7.6 CONTROL OF MONITORING AND MEASURING DEVICES PMT determines the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of


product to determined requirements. Equipment for final inspection is considered any equipment that is in the calibration system. The PMT spreadsheet in the Quality folder on the server is the list of inspection equipment for the company. It shows the due date for calibration of equipment. Calibrations are performed by a subcontractor. The method for calibration of equipment is controlled by the subcontractor. Since most equipment can be used in the Inspection Room or in Production, the location of all equipment is the premises of the PMT. Employee inspection equipment is considered For Reference Only and may or may not be stickered as such. Gauge pins are considered For Reference Only but are checked before use in inspection. If required, PMT ensures that environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out. Where necessary to ensure valid results, measuring equipment is:

calibrated or verified at specified intervals, or prior to use, using standards traceable to NIST. Where no such standards exist, the basis used for calibration or verification is recorded;

adjusted or re-adjusted as necessary;

identified with stickers to enable the calibration status to be determined. Exception would be employee-owned equipment for reference only;

safeguarded from adjustments that would invalidate the measurement result;

protected from damage and deterioration during handling, maintenance and storage;

recalled using the list of inspection equipment If any equipment is found to be out of calibration, PMT assesses and records the validity of the previous measuring results, as follows:

Action is taken to determine the extent of the out-of-calibration condition.

If product or parts inspected by this equipment are still in-house, it will be re-inspected and appropriate action taken.

Records of this action will be maintained on the Corrective Action Request (CAR).

If the product or parts have been shipped, the customer is contacted to coordinate and correct the problem.

Record of related action will be made in a hard-copy format (mail or email) and included with the CAR.

Calibration Records are maintained per the Quality System Records Control matrix. When used in inspection of specified requirements, the capability of computer software is confirmed. When required, this is done prior to initial use and reconfirmed as necessary. Corrective action is taken if warranted. The CAR is evidence of action taken.


8.0 Measurement, analysis and improvement 8.1 GENERAL PMT has implemented the monitoring, measurement, analysis and improvement processes required to: a) demonstrate conformity of the product by 100% inspection b) ensure conformity of the quality management system, and c) continually improve the effectiveness of the quality management system This includes determination of applicable methods, including statistical techniques, and the extent of their use. According to the nature of the product and depending upon the specified requirements, PMT may use statistical techniques. 8.2 MONITORING AND MEASURING 8.2.1 Customer Satisfaction As measurements of the performance of the quality management system, PMT will monitor information relating to customer perception as to whether the company is meeting the customer’s requirements. PMT will use customer telephone calls, e-mails, fax letters, and written letters as one way to determine their satisfaction. PMT will use customer performance rating charts as another way to determine their satisfaction, when available.

8.2.2 Internal audit PMT conducts internal audits at planned intervals to determine whether the quality management system:

Conforms to the planned arrangements (see 7.1), to the requirements of AS9100, Revision B, and to the quality management system requirements established by the company

is effectively implemented and maintained The internal audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits.

The audit criteria, scope, frequency and methods are defined as follows:

Criteria – The area of the Quality Management System that is being audited. This is found in the Internal Audit Schedule.

Scope – The specific Quality Management System criteria that are being audited and/or specific objective evidence to examine. This is found in the Internal Audit Schedule.

Frequency – How often the elements of the Quality Management System are audited. This is found in the Internal Audit Schedule.

Methods – How the audits are conducted. This is listed in the remainder of this section of the manual.


Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. Auditors are selected by the QC Manager and can include subcontracted auditors.

The responsibilities and requirements for planning and conducting audits, reporting results and maintaining records (see 4.2.4) is defined as follows: QC Manager Sets the audit schedule Determines the auditors Maintains the audit records Develop checklist inputs Follow-up on corrective actions from the audits Auditors Develop the Checklist Collect objective evidence Create the internal audit report The following explains the procedure for the internal audit process: Planning

The Management Representative is responsible for coordinating the internal audits. Management will select certain activities for auditing. This may depend on their status, importance and past audit history.

The audit schedule lists the activities to be audited for the current year Auditors

Audit personnel are independent of those having direct responsibility for the audited activity. The Management Representative assigns auditors for each audit and will participate in audits as required. Contracted auditors may also be used.

Personnel from any department may be part of an audit team after they are trained in auditing techniques. External training and/or certification of auditors is recommended but is not required. The Management Representative has the responsibility of getting auditors trained prior to performing any audits.

Activities that are the direct responsibility of the Management Representative are audited by auditors from another department or by a contracted third party auditor acting on behalf of PMT using company forms.

Preparation for Audit Auditors prepare for an audit by: Reviewing the quality manual and related procedures Reviewing related Corrective Action Requests, if any Preparing a checklist to guide the audit

It may be necessary that the auditors review the standards prior to conducting the audit. The checklists may be based on the standards and the company’s documentation as needed or desired for the particular audit scope.

Auditors may include other documentation in the audit “packet”.


Conducting an Audit

The auditors use the Internal Audit Checklist to perform the audit but they may add additional items to audit based on findings during the audit.

Auditors look for objective evidence demonstrating whether the audited activities comply with the requirements of the documented quality system. If possible, copies of the objective evidence are made and included as records

Findings, positive and negative, are entered on the Internal Audit Report or reference is made to other audit records.

Noncompliance’s are listed on the Internal Audit Report form and may require corrective action. These should be followed-up with the person responsible for the area audited. Findings requiring corrective action are documented on a Corrective Action Request.

The initiator of the Corrective Action Request or the Management Representative does follow-up on the corrective action. Objective evidence should exist to verify effective implementation.

The lower section of the Internal Audit Checklist/Summary is used to summarize and close out the audit.

Documentation and Record

Internal audits are documented by the Internal Audit Checklist, Internal Audit Report, related documentation and any copies of supporting objective evidence.

Corrective action and the follow-up will be documented using the Corrective Action Request.

All records are controlled based on the Quality System Records Control matrix. This matrix is found in the Quality System Control folder of the Quality System on the network.

8.2.3 Monitoring and measurement of processes PMT uses suitable methods for monitoring and measurement of the quality management system processes. Internal audits and management review will be used to monitor and measure processes. These methods demonstrate the ability of the processes to achieve planned results. If planned results are not achieved, correction and/or corrective action are taken, as appropriate, to ensure conformity of the product. In the event of process nonconformity, PMT will: a) take appropriate action to correct the nonconforming process, b) evaluate whether or not the process nonconformity has resulted in product

nonconformity, and c) identify and control the nonconforming product in accordance with paragraph 8.3 8.2.4 Monitoring and measurement of product PMT monitors and measures product characteristics to verify that product requirements have been met. This is carried out in accordance with the Shop Order. If key characteristics have been identified, they are monitored and controlled.


If PMT uses sampling inspection as a means of product acceptance, the plan is statistically valid and appropriate for use. The plan does not allow the acceptance of lots whose samples have known nonconformities. When required by contract, the plan shall be submitted for customer approval. No product is used until it has been inspected or otherwise verified as conforming to specified requirements, unless product is released under positive-recall procedures pending completion of all required measurement and monitoring activities. Positive recall is as follows:

Material used is noted on the Shop Order as “Not inspected”

The lot number for the material is also noted.

Material is used and product is manufactured

In the event that there is a problem with the material after product has been shipped, other product from that lot of material is investigated for possible problems.

Corrective action is taken if deemed necessary. Evidence of conformity with the acceptance criteria is maintained. Quality records indicate release of the product and the person(s) authorizing release of product. No product will be delivered until all the operations on the Shop Order have been satisfactorily completed, unless otherwise approved by the customer. The QC Manager provides final verification prior to shipping. 8.2.4.1 Inspection Documentation Measurement requirements for product acceptance are documented. Information provided includes:

criteria for acceptance and/or rejection,

where in the sequence measurement and testing operations are performed,

a record of the measurement results, and

the type of measurement instruments required and any specific instructions associated with their use

Test records shall show actual test results data when required by the Shop Order. Where required to demonstrate product qualification, PMT shall ensure that records provide evidence that the product meets the defined requirements. 8.2.4.2 First Article Inspection PMT provides for first article inspections using form AS9102. A representative part from the first production run will be verified and the results recorded in accordance with the Purchase Order. A new first article inspection is required following any subsequent change that invalidates the previous first article inspection result. 8.3 CONTROL OF NONCONFORMING PRODUCT Nonconforming material is identified and controlled as required. This control allows for:


scrapping nonconformities

reworking nonconformities (inspect to print dimensions after rework)

accepting nonconformities with appropriate customer approvals (use-as-is)

approving nonconforming material for other use If an operator makes a part that he thinks is nonconforming, the following procedure is followed:

The operator takes the part to the QC Manager.

A Discrepancy Tag is completed and attached it to the part.

The part is segregated, if possible.

A Corrective Action Request may be completed with disposition.

If the operator is told to rework the part, it is inspected to print specifications after rework.

If the part might be acceptable as is, the customer must be contacted for approval. Acceptance by the customer must be in hard-copy of email.

If scrapped, someone will cut it up to make it unusable and then place it in a scrap container for recycling. An exception to this is if a part (material) is customer supplied, then it will be returned with the order. If kept for set-up use later, it will be marked and controlled by the QC Manager and must be checked-out for use.

If the QC Manager finds any nonconforming product during any inspection, the same procedure is followed. If a nonconforming part(s) is returned from a customer, the following procedure is followed:

The QC Manager completes a Discrepancy Tag and attaches it to the part.

The part is inspected to verify the customer’s claim and determine final disposition.

If the disposition is to rework the part, a Shop Order is created and put with the product(s). The rework is completed and the part is re-inspected to print.

If scrapped, someone will cut it up to make it unusable and then place it in a scrap container for recycling. An exception to this is if a part (material) is customer supplied, then it will be returned with the order. It may be kept for set-up and controlled by the QC Manager.

If nonconforming material or a part(s) is received from a supplier, the following procedure is followed:

The QC Manager completes a Discrepancy Tag and attaches it to the material or part(s).

The product is inspected to determine disposition.

The QC Manager will contact the supplier for correction of the problem and/or corrective action using the Corrective Action Request if deemed necessary.

At any time that rework of a part is to be performed a Shop Order is developed and placed with the part. Parts for rework are placed with other work-in-process. Discovery of nonconforming material after delivery is immediately followed by the actions necessary to minimize its impact and preserve customer satisfaction to the


highest level possible under the circumstances. This is usually done by phone or email from the QC Manager. The email and/or a Corrective Action Request, if applicable, are used as a record of the contact. If required by the customer, additional records will be developed and provided. Those persons authorized to disposition nonconforming product are listed on the Authority Matrix. Current personnel with this authorization have been selected and approved by the President and QC Manager. To add to the list additional persons follows the process:

The President or the QC Manager will decide who is qualified.

The person will be asked if they wish to have that responsibility.

The person will be involved in training with nonconforming product disposition as available.

If deemed qualified, the person’s name is added to the Authority Matrix. 8.4 ANALYSIS OF DATA At PMT, the quality management system related data is recorded and maintained. The data is analyzed with the objectives below in mind and used to determine the suitability, effectiveness and opportunities for improvement of the quality management system. The data analysis objectives for PMT are:

to assess customer satisfaction levels

to determine success rates in fulfilling customer product requirements

to gather knowledge on trends associated with products and processes in order to initiate appropriate preventive action

to maintain awareness of the performance of suppliers and request them to take action to correct or improve their performance

8.5 IMPROVEMENT 8.5.1 Continual improvement PMT strives to 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. 8.5.2 Corrective action In order to avoid the recurrence of problems, appropriate corrective actions are taken. Corrective action involves:

reviewing nonconformities including customer complaints

the determination of causes of nonconformities

assessing the need for actions to avoid recurrence

the determination of corrective actions needed

the implementation of determined corrective actions

making records of the outcomes from actions taken

verifying the effectiveness of corrective actions taken


The procedure for correction/corrective action is as follows: a) When a situation described above occurs, the QC Manager may initiate a Corrective

Action Request (CAR) to provide a record of the occurrence. b) If initiated, The QC Manager will determine if correction is all that is needed or cause

and corrective action. The CAR is tracked on the CAR Log. c) If cause and corrective action is required, the CAR may be routed for completion of

cause/root cause section of the CAR or the QC Manager may complete it based on any investigation of the problem.

d) Once the corrective action is determined, assignments to bring about corrective action will be issued.

e) Once all actions are completed, the QC Manager will verify completion of the action. f) A date for verification of effectiveness of the action is agreed to. g) The CAR is closed out when the action is either deemed effective or there is mutual

agreement that effective action cannot be made. h) The Corrective Action Request is filed by the QC Manager and the CAR Log is

updated. If a supplier is responsible for the root cause of corrective action, the requirement for corrective action flows down to that supplier. This can be done by:

telephone to the supplier by the QC Manager. All corrective action stated by the supplier can be recorded on the Corrective Action Request with the name of the person who provided the information and the date.

Email to the supplier asking for corrective action supplied in a return email, or

A PMT Corrective Action Request is issued to the supplier. The supplier may choose to attach their own form for corrective action.

Each Corrective Action Request will state a suggested due date for corrective action (internally and supplier). This is negotiable if adequate justification can be provided. If corrective action is not achieved in a timely manner as listed on the Corrective Action Request or the action is not effective:

the person or supplier responsible for corrective action will be contacted.

if more time is needed, a new due date is agreed upon.

if ineffective, new corrective action will be required.

if an PMT employee does not complete the action, they are subject to disciplinary action and someone else may be asked to complete corrective action.

If a supplier, they are warned by verbally and by email. They can be removed from their approved status. If they are required by a customer, the customer may be contacted to assist in bringing about action as required.

All records are controlled based on the Quality System Records Control matrix. This matrix is found in the Quality System Control folder of the Quality System on the network. 8.5.3 Preventive action In order to avoid the occurrence of potential problems, appropriate preventive actions are taken. These actions can be taken as a result of a management review meeting.


The process for preventive action includes:

the determination of potential nonconformities

the determination of causes of potential nonconformities

the determination of preventive actions needed

the implementation of determined preventive actions

making records of the outcomes from actions taken

reviewing preventive actions taken The procedure for preventive action is as follows: a) When warranted by trends in data or a situation described above, a Preventive

Action Request is initiated or it is created from action items from Management Review.

b) The preventive action must describe the potential problem/nonconformance. c) If the PAR form is used: The problem section is completed and the form is given to the person who has

control of the subject area. This person completes the cause(s) section as well as the preventive action

section, assigning responsibilities. Once all actions are completed, the person who initiated the form is contacted to

verify completion of the action. A date for verification of effectiveness of the action is agreed to. The Preventive Action Request is closed out when the action is deemed effective

and filed in the Inspection Room files. All records are controlled based on the Quality System Records Control matrix. This matrix is found in the Quality System Control folder of the Quality System on the network.

Professional Machine and Tool

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