Obtained From SQA Difference Between Iso 9001 and as 9100

8/13/2019 Obtained From SQA Difference Between Iso 9001 and as 9100

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Smithers Quality Assessments, Inc. | 425 West Market Street | Akron, OH 44303 | 1-866-688-0134www.smithersregistrar.com

Presents

Quality Management SystemAerospace Requirements

Differences betweenISO 9001:2000 and AS9100B

John R. Sedlak

January 2006(Revised August 2006)

(Revised May 2013)


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Differences between ISO 9001:2000 and AS9100B

Provided by: Smithers Quality Assessment, Inc. | 425 West Market St. | Akron, OH 443031-866-688-0134 | www.smithersregistrar.com

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About the Company

Smithers Quality Assessments (SQA), founded in 1993, is an accredited quality,

environmental and safety management systems certification body serving industrial,

commercial, government, and service businesses.

We are accredited as a registrar for the following standards:

- ISO 9001 Quality

- ISO 14001 Environmental

- ISO/TS 16949 Automotive

- AS 9100 Aerospace

- ISO 13485 Medical Device- OHSAS 18001 Health & Safety

Additional services include:

- 1stParty Internal Audits

- Gap Analysis

- GMP (Good Manufacturing Practices)

- GLP (Good Laboratory Practices)

- 2ndParty Supplier or Special Audits

For over 20 years, SQA has built its business on the philosophy of education and

preparation leads to success and a no surprises approach to customers. Every

customer is important to us, regardless of size. We are always upfront, honest and fair

in our business practices.

To best serve SQAs growing client base, we have our world headquarters located in

Akron, OH and supporting offices in the United Kingdom and China.


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Introduction:

The material contained in this paper is intended for organizations that wish to complywith the requirements of AS9100B and personnel who are engaged in auditing therequirements.

The focus is limited to the differences (deltas) between ISO 9001:2000 and AS9100B.It assumes that the requirements of ISO 9001:2000 are understood by the user.

It should be noted that throughout AS9100B, there are requirements that makereference to contract requirements and/or regulatory authorities. In suchcases, it is mandatory to first refer to the contract and, as applicable, regulatoryrequirements and make a determination of applicability.

Since Notes are included for guidance, they have not been treated as requirements.This does not in any way diminish their importance.

Disclaimers:

Each section has three parts:

Requiremento The clause and/or sub-clause number containing the differences is listed,

along with a summary of the subject applicable subject matter. For the fulltext of the requirements, the reader will need to refer to the copyrightedversion of AS9100B.

Copies of AS9100B can be obtained from:

SAE World Headquarters400 Commonwealth DriveWarrendale, PA 15096-0001 USA

Phone: 724-776-4841www.store.sae.org

Summaryo This is the authors attempt to emphasize the key points of each clause.

In no way should the reader rely on summaries to be all-inclusive. The

text of AS9100B is the source document.

Audit Guidanceo These are suggested audit techniques and considerations, which have

been reviewed by qualified AS9100B auditors. They are in no way meantto be all-inclusive. Each circumstance will have its own unique set ofconsiderations. As always, an effective audit relies heavily on theexperience and knowledge of the auditor.
http://www.store.sae.org/http://www.store.sae.org/http://www.store.sae.org/


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REQUIREMENT

1 SCOPE:

SUMMARY

ISO 9001:2000 is the basic requirement.

Additional requirements have been added specific to the aerospace industry.

Exclusions are limited to requirements within Clause 7, and such exclusionsdo not affect the organizations ability, or responsibility, to provide product orservice that meets customer and applicable regulatory requirements.o Some elements of the QMS may be executed for a site at a remote

location, such as a corporate office. Regardless, the functions must beincluded in the scope of the QMS, with reference to where these remote,support functions are executed.

All applicable elements of AS9100B must be addressed by the variousorganizational processes and included in all certification activities.

AUDIT GUIDANCE

No special guidance is required for qualified auditors.

All applicable elements and organizational processes must be subjected toassessment both for initial and recertification assessments; sampling of theseorganizational processes is permitted during on-going surveillance actions.

All exclusions must be justified by the organization being certified.

If specific processes are executed at a remote location(s), it is incumbent

upon the auditor to determine the effectiveness of the interactions betweenthe various locations.


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REQUIREMENT

3.4.2 PRODUCT:

SUMMARY

This is a basic definition of product, with emphasis on aerospace industryconsiderations.

Focus is on the intended product (that which is purchased by the customer).

By-products effecting the environment are generally excluded (see below).

Products can be of a hard (washers, engines, propellers) or soft (knowledge,concepts) nature.

In most cases, the scope of the certification audit will be limited to the qualitymanagement system under which the products are manufactured.

The one exception for this is those special cases where the organization has

integrated its QMS with its EMS (ISO 14001). In these cases, the by-products of the process may enter into a certification decision. However, itwill be under the requirements of ISO 14001, not AS9100.

AUDIT GUIDANCE

The scope statement that will ultimately be stated on the certificate is veryimportant. It must define the products and/or services being supplied by theorganization, and the general processes used to produce and deliver them. Itmust also include reference to any remote, support locations.

During document review and, if applicable, pre-assessment, pay special

attention to the way the quality management system (QMS) has beendocumented; determine if the documented QMS fully encompasses theproducts and/or services provided by the organization.

Early in the assessment process, determine if the QMS and environmentalmanagement system (EMS) are integrated. If they are, the audit team willneed someone that is qualified for EMS.


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REQUIREMENT

3.3.1, -.5, -.6 ORGANIZATION:

SUMMARY

The three terms listed above define the macro process flow:o Customers provide requirements to organizations.o Organizations pass down requirements to suppliers.o Suppliers provide materials and services to organizations.o Organizations provide products to customers.

These three terms define the relationships that exist in all businessorganizations. Requirements ultimately start with customers. Organizationssupply products, often using the services of suppliers.

AUDIT GUIDANCE

For the most part, these terms will be audited as part of the overallassessment process, perhaps with emphasis on the purchasing and designprocesses (if applicable at the site being assessed).


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REQUIREMENT

3 KEY CHARACTERISTICS:

SUMMARY

The term key characteristic is not unique to aerospace, but it does have ahigh level of importance. In other industries, the following terms are similar:special characteristics, key product characteristics and critical characteristics.

Note that this term applies not just to product, but also to material andprocesses.

Safety is often a consideration when designating key characteristics.

It is common for some sort of symbol to be used to highlight or designate keycharacteristics.

Key characteristics can be designated by the customer or by the organization.

As applicable, the existence of key characteristics must be communicated toall applicable personnel, including suppliers. (Refer to configurationmanagement.)

Key characteristics often have special controls associated with them, e.g.,SPC, special records and/or tests, special tools, special training for applicablepersonnel.

AUDIT GUIDANCE

Review the organizations quality documentation and/or engineeringdocumentation (product and/or process) to determine: a) how key

characteristics are determined, b) how they are designated, c) how they arecommunicated, and d) how they are controlled.

Review working documents to see if key characteristics are clearlycommunicated, as applicable.

Review records for those key characteristics that have special controlsdefined.

Review performance to verify that these key characteristics are reviewed atthe frequency required.


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REQUIREMENT

4.2.1f GENERAL:

SUMMARY

It is not uncommon for customers and/or regulatory agencies to pass downrequirements to organizations. Whenever this occurs, it is required that theorganization develop methods for including such requirements in itsdocumented quality management system.

There are many specific requirements that could be passed down. Someexamples are:o Requirement for specific non-destructive evaluation.o Requirements to use specified suppliers.o Special labeling requirements.

AUDIT GUIDANCE

Examine customer purchase orders. Look for specific requirements that maybe passed down.

If requirements are passed down, verify that they have been included withinthe documented QMS.

Request that the organization provide you with documents from regulatoryagencies (e.g., FAA) that have requirements applicable to the organizationand/or product being produced by the organization.

Assess the effectiveness of the accessibility of documents to those

employees that have a need for their use.


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REQUIREMENT

4.2.2b QUALITY MANUAL:

SUMMARY

Generally, in ISO 9001 systems, it is not required to make direct linkage orreference in organization procedures to the clauses of the Standard.However, AS9100B makes this a requirement.

This requirement is limited to those procedures that are required by thestandard as well as those that the organization determines to be necessary.

AUDIT GUIDANCE

During the document review phase of the assessment, and during theassessment of all changes to the QMS, pay particular attention to how theorganization has met this requirement.

There are various methods to meet this requirement, such as:o Inclusion of the ISO 9001 clause reference in each procedureo Creation of a matrix listing each procedure and the corresponding clause

of the standard.o Referencing the procedures within the applicable clause in the quality

manual.


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REQUIREMENT

4.2.3 g. CONTROL of DOCUMENTS:

SUMMARY

This is a requirement aimed at keeping those that have a need-to-knowinformed. The purpose is to prevent unintended consequences.

AUDIT GUIDANCE

If the organization maintains a change log, as part of each assessmentactivity, review it for the documents comprising the AS9100B QMS. Ascertainif customers and/or regulatory bodies have been notified of such changes. Ifnot, determine if there is legitimate justification for the lack of notification.o NOTE: If there is a contractual requirement for notification, there is no

justification for any lack of notification.o This requirement may apply to customer-supplied documents, e.g., part

drawings and other design documents.

If a change log is not maintained, the auditor will have to determine how theorganization controls changes to documents how the changes arecoordinated with customers and/or regulatory authorities.


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REQUIREMENT

4.3 CONFIGURATION MANAGEMENT:

SUMMARY

Configuration management involves control of all documents that pertain tothe product, including such items as part drawings, material specifications,field service manuals, installation instructions, cross-reference documents,part samples, warranty documents, just to name a few.

A key aspect of configuration management is interchangeability ofcomponents.

Another aspect deals with existing inventory and product in the field.o A sub-category of this, as warranted, may be product recall.

AUDIT GUIDANCE

Start with a review of the process the organization has defined regardingconfiguration management.

Determine if the extent of the process is appropriate to the product.

Review records of recent changes with emphasis on interchangeability,inventory, field stock (if applicable), and product already in use.

Review drawing notes for listed requirements. Determine if the configurationmanagement program has addressed them as applicable and appropriate.


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REQUIREMENT

5.5.2 MANAGEMENT REPRESENTATIVE:

SUMMARY

In aerospace focused manufacturing, there is a need to have at least oneperson inside the organization that, in a very real sense, has the authority tospeak for the customer or regulatory authority. This person must be themanagement representative (MR)as a minimum.

Having organizational freedom means that this person does not need toseek authority for each action on a case-by-case basis. Rather, the MR isauthorized to take action that is binding upon the organizationperiod!

AUDIT GUIDANCE

Review the quality documentation and determine how the authority of the MRis defined.

Determine if there are any limitations on the authority of the MR. If there are,ascertain if these limitations are legitimate and do not conflict with thisrequirement.

Ask to review records of actions where the MR executed his/her authority;check consequences, follow-up, etc.

Review the organization chart and reporting relationships. Determine if thereis true organizational freedom.


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REQUIREMENT

7.1 e PLANNING OF PRODUCT REALIZATION:

SUMMARY

ISO 9001:2000 does not get specific regarding maintenance, whereasAS9100B does.

Resources includes personnel, equipment, repair parts, tooling and/ormachine repair and maintenance facilities (may be internal or external).

AUDIT GUIDANCE

Interview personnel in the maintenance department. Ascertain their level ofcompetence.

Review the organizations inventory of repair parts, tools, etc.

Review the organizations maintenance and/or tool repair facilities. If either ofthese is outsourced, pay particular attention to the controls established by theorganization to assure that product continues to meet all requirements.

Review maintenance and/or tool repair records. Look for evidence of post-action conformance of product.

Determine if maintenance activities are occurring as scheduled.

Determine if there are any bottle necks in the manufacturing process. If so,are they due to a lack of resources?


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REQUIREMENT

7.2.2d REVIEW OF REQUIREMENTS RELATED TO PRODUCT:

SUMMARY

In essence, this requirement says: Dont just take the order.

There is a defined requirement to recognize risks, analyze their potentialimpacts, and take actions to mitigate negative effects.

Another view: Dont assume anything. If there is anything that is in question,work with the customer in advance. The goal is prevention of problems.

AUDIT GUIDANCE

Review evidence of contract review processes/actions.

Determine how the organization goes about identifying potential risks, actionstaken, level of customer involvement.

Review records of such actions, including customer inputs and/or responses.


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REQUIREMENT

7.3.1a DESIGN AND DEVELOPMENT PLANNING:

SUMMARY

The emphasis is on the planning process for design.

Questions: Are there sufficient trained and competent personnel? What arethe sequential steps for design activities? Of these steps, which aremandatory and significant? (E.g., validation testing, change approval,prototyping.) Has there been any assignment(s) to other personnel in theorganization?

Configuration control is a key consideration (see 4.3).

AUDIT GUIDANCE

Review the design planning documents for recent projects.

Determine how the organization has addressed this requirement.

Review records of actions from mandatory and significant design planningsteps.

Determine if the organization has executed effective configuration control.(4.3)


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REQUIREMENT

7.3.1c DESIGN AND DEVELOPMENT PLANNING:

SUMMARY

Design projects run the range from very simple (one component) to verycomplex (space shuttle).

The organization must make a good-faith effort to classify new projects to theappropriate level of complexity.

As complexity increases, there will be increasing needs to assure thatresponsibilities, authorities, and other key design considerations are definedand controlled.

Emphasis is on personnel, design input, constraints and performanceconditions.

Throughout, the design process must assure that contract requirements aremet.

There is added emphasis on safety and functional objectives of the product.

AUDIT GUIDANCE

Same as 7.3.1a

Review the process used by the organization to determine the projectcomplexity. Do you agree?

Review the timing between design steps.

Determine if safety and functional objectives are applicable. If they are, have

they been defined? Do records indicate that such objectives have been met?


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REQUIREMENT

7.3.3e DESIGN AND DEVELOPMENT OUTPUTS:

SUMMARY

In essence, this is an example of configuration management. (4.3)

The emphasis is on the finished product.

AUDIT GUIDANCE

Review the output documents of a design project.

Determine if there is clear and adequate definition of the product and allrelated requirements, such as those listed above.

Examine engineering change control documents to determine if the integrity

of the configuration has been maintained at all applicable points of control. Review any changes in assignments and how they effect the final design

output and timing of the project.


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REQUIREMENT

7.3.4 DESIGN AND DEVELOPMENT REVIEW:

SUMMARY

This requirement is focused on personnel that have defined authority topermit the design process to continue to the next step.

Inherent in this requirement are the issues of: effective contract review;competent personnel; team involvement (if required); as applicable, customerinvolvement.

AUDIT GUIDANCE

Determine how the organization has designated those personnel with definedauthority to permit design processes to proceed through the various steps.

Look for records that verify that such authority was exercised at theappropriate design steps/phases.

Determine if review has been limited to design personnel. If otherdepartments/functions have not been included, it may be that problems willoccur in the manufacturing process.


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REQUIREMENT

7.3.6.1 DOCUMENTATION OF DESIGN AND/OR DEVELOPMENTVARIFICATION AND VALIDATION:

SUMMARY

In the context of this clause, verification refers to inspection activities, e.g.,checking of a drawing, measurement of prototype parts, solid modeling,inspection records, comparison to similar designs, sample calculations,among others.

Validation refers to performance testing under defined conditions.

This requirement is focused on the documentation or computer modeling thatexists to show that all requirements have been met.

There is emphasis on product meeting requirements throughout identifiedoperational conditions (e.g., vibration, temperature, g-forces, life cycles,exposure to water, chemicals, etc.)

AUDIT GUIDANCE

Review records of verification and validation test results.

Ascertain whether or not records indicate conformance.

In those cases where conformance is not indicated, determine what actionsthe organization took to resolve the situation.

If required, have the customer or other outside agency (e.g., FAA, military)been involved?

Is the approval process adhered to?


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REQUIREMENT

7.3.6.2 DESIGN AND/OR DEVELOPMENT VERIFICATION AND VALIDATIONTESTING:

SUMMARY

The emphasis is on control of allaspects of verification and validation testing.

In a few words: be sure the correct product, at the correct revision level andstatus, is being tested; the test method is defined and adhered to; results arerecorded; test results meet defined requirements.

AUDIT GUIDANCE

Review the documentation defining verification and validation testingrequirements.

Determine if the methods are correct to defined requirements.

Review test results for conformance to defined requirements.

Are all failures documented?

As applicable and required, are the customer and/or outside agenciesinvolved?


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REQUIREMENT

7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES:

SUMMARY

Changes are very important to all aspect of aerospace manufacturing.

It is not uncommon for contracts to have defined requirements for customerand/or regulatory authorities to reserve authority for all changes.

Even if an organization is design responsible, there may be contract orregulatory authorities to reserve authority for change approval for themselves.

Changes may effect the airworthiness of an aircraft. The customer and FAA(or equivalent agency in a foreign country) must be involved.

AUDIT GUIDANCE

Review contract requirements.

If there are contract requirements for customer and/or regulatory authorityinvolvement in design and development changes, ascertain if the organizationis adhering to the defined requirements.


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REQUIREMENT

7.4.1a-e PURCHASING PROCESS:

SUMMARY

It is not uncommon for customers to designate suppliers for certain materials,components, assemblies, and services.

Being customer-designated does not relieve the organization ofresponsibility for controlling the quality from such suppliers.

All suppliers are to be approved via an organization-defined process; thisincludes a disapproval process and defined authority for all such actions.

There is special emphasis on out-sourced special processes, such aswelding, plating, Non-destructive Evaluation (NDE), etc.

There may be customer approval required for outsourced work.

There may be NADCAP approval required for special processes.

AUDIT GUIDANCE

Review contracts, engineering requirements, part drawings.

Determine if there are any customer-designated suppliers, or if there is arequirement for customer approval of suppliers.

Review the receiving and in-process inspection records that pertain to thesesuppliers; check for incoming and in-process conformance.

If the organization has a defined supplier control process that involvessupplier on-site evaluations, review records.

Compare supplier records to the approved-supplier list. Determine that allbelong on the approved list.

Look at corrective action requests issued to suppliers. Determine if action isappropriate and effective.

Review supplier performance data.

Determine, as applicable, if NADCAP or customer approval was obtained.


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REQUIREMENT

7.4.2d-j PURCHASING INFORMATION:

SUMMARY

The overriding theme of this list of requirements is communication ofimportant information, at the current or applicable level, to appropriate parties.

The details of these requirements are, for the most part, self-explanatory.There is emphasis on communication upstream and downstream in the eventof a problem.

Suppliers are not to change product or manufacturing processes without firstinforming the organization.

Right of access to suppliers (and, as applicable, to sub-tiers) facilities andapplicable records is required; applies to the organization, customers andregulatory authorities

If supplier purchase from lower tiers, they have a responsibility to pass-downapplicable requirements and controls.

AUDIT GUIDANCE

Start with the contract and engineering documents.

Determine what is being purchased.

Review purchasing documents to determine if all of these requirements arebeing met in the documented quality management system as well as inpractice; verify all flow down requirements.

Pay special attention to those cases where suppliers are purchasing from

sub-tiers.


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REQUIREMENT

7.4.3a-e VERIFICATION OF PRUCHASED PRODUCT:

SUMMARY

This requirement provides a list of acceptable methods for supplier-providedproduct by the organization.

The method must be appropriate and effective.

Generally, dont use product until it is approved. Positive recall is permitted,but should not be used unless fully warranted and the process effectivelyprevents the flow of nonconforming product to the customer.o Work that has been subcontracted generally has paperwork associated

with its delivery to the organization, e.g., test reports, data packages, etc.

Test reports need to be periodically validatedtypically by the organization oran outside laboratory.

Delegation is a highly visible process, not to be taken lightly. Those that aregranted delegated authority must be competent and be granted authority forunencumbered decision making.

As warranted by contract, customers and their representative must be able toverify product at suppliers prior to use by the organization. Such verificationshall not be used by the organization as evidence of acceptancethat is, theorganization retains it own responsibility to verify conformance of purchasedproduct even if the customer has pre-inspected it and found it to beacceptable.

AUDIT GUIDANCE

Review organization-defined methods for acceptance of purchased product.

Determine if these methods are/will be effective.

Review records for conformance of purchased product.

If authority has been delegated, review the basis of competency for theperson(s) to whom authority has been delegated; review the list ofdelegations.

Review purchasing documents to determine how suppliers are informed oftheir requirement to permit on-site verification of product by customers.

Determine if there are any instances where customers have pre-inspected

product at suppliers; verify that the organization has also performed itsdefined verification controls.


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REQUIREMENT

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION:

SUMMARY

A control plan lists the methods used at each operation to assureconformance of product (e.g., gages, frequency, records, SPC, operations,actions to take if nonconforming product is identified); required for keycharacteristics.

If product transformation actions make inspection impossible, upstreamcontrols are required.

There is a requirement for utilization of variable measurements to be taken;minimize the use of attribute gages, e.g., go/no-go gages.

Special processes (e.g., welding, plating, painting) require special controls.

AUDIT GUIDANCE

Assess the effectiveness of in-process control methods.

Special emphasis on key characteristics, and special processes.

Control plans are required for key characteristics.

Evaluate the effectiveness of upstream inspection/control points to preventthe production of (or at least the flow of) nonconforming product.


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REQUIREMENT

7.5.1g-k CONTROL OF PRODUCTION AND SERVICE PROVISION:

SUMMARY

This requirement addresses the need to account for all materialfrom start tofinish to preclude the occurrence of nonconforming product being shippedto the customer.

Consideration given to split lots duplication of applicable paperwork,configuration control, especially of non-used product is placed back intoinventory.

The prevention damage from the presence of foreign objects is of highimportance in aerospace work. (FOD = foreign object damage.) Foreignobjects are any objects that does not belong in/with the defined product.Typically, this may include items like dirt, chips, wrong or mixed parts.

Criteria for workmanship means communicating how to determine good fromnonconforming. If representative samples are used, they need to becontrolled in a manner similar to gages.

AUDIT GUIDANCE

Assess the effectiveness of the organization to account for all material andparts from start to finish; special emphasis on split lots, reworked or repairedproduct (must be done in accordance with approved procedures)

Examine parts bins, inventory storage areas for the presence of foreign

objects. Determine if the process/methods for conveying workmanship criteria are

effective and controlled.

Look for split lots. If this has occurred, determine if all processing executedafter the split has been documented, e.g. routers updated or annotated,inspection sheets, test reports, etc.


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REQUIREMENT

7.5.1.1 PRODUCTION DOCUMENTATON:

SUMMARY

Production operations shall be executed in such a manner that all personnelhave available to them correct and current data.

Part of this control includes the listing of required tooling and, as applicable,numerical control information.

AUDIT GUIDANCE

Review the documentation that accompanies product through themanufacturing processes.

Determine if this documentation is sufficient to assure conforming product atall phases of manufacturing.

If NC controls are in place, determine if they are controlled to the extentnecessary to assure current, conforming product.

If NC controls are in place, determine if the same version of the NC programhas been used on all parts in the lot. If not, was there a review of this actionand were results acceptable?


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REQUIREMENT

7.5.1.2 CONTROL OF PRODUCTION PROCESS CHANGES:

SUMMARY

Changes require proper control similar to design changes.

All changes must be documented.

It is not uncommon for customers to require their approval of any processchange.

If a process is changed, the effect on the resultant product must be evaluatedto validate continued conformance.o This may include changes to NC programs.

AUDIT GUIDANCE

Determine if customers have defined process changes.

Review customer contracts; ascertain the degree of required involvement.

Review records of process changes, with emphasis on validation records forresultant product.


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REQUIREMENT

7.5.1.3 CONTROL OF PRODUCTION EQUIPMENT, TOOLS AND NUMERICALCONTROL (NC) MACHINE PROGRAMS:

SUMMARY

Tooling needs to be validated prior to production.

One common method is termed first article inspection. There are others.

Tooling needs to be maintained, during use and when in storage.

Tooling needs to be inspected periodically in accordance with documentedprocedures.

AUDIT GUIDANCE

Review records for new and/or rebuilt/refurbished tooling. Determine if the records demonstrate effective validation, that is, capability of

producing conforming product on a continuing basis.

Observe tooling held in storageassess for effective protection.

Determine how the organization verifies that tooling held in storage isdetermined to be current prior to each use, that is, as applicable, it has beenupdated to meet current design revision levels.

Determine if changes or modifications to NC programs required a new first-article. If so, was it done?


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REQUIREMENT

7.5.1.5 CONTROL OF SERVICE OPERATIONS:

SUMMARY

Service typically occurs after delivery. It differs from warranty work.

Since service activities have the potential to effect product quality, they areexpected to have equal, and sometimes more, control than the originalmanufacturing processes.

Servicing often involves working with multiple revision levels read,configuration control.

AUDIT GUIDANCE

Determine if the organization has contractual requirements for post-deliveryservice.

If yes, determine how the organization assures conformance at the requiredproduct revision level.

Evaluate the competency of service personnel.

Evaluate the calibration of tools and/or gages used in service applications.

Review service records to determine how service-related information isreviewed and used by the organization.


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REQUIREMENT

7.5.2a & c VALIDATION OF PROCESSES FOR PRODUCITON AND SERVICESPROVISION:

SUMMARY

Special processes are those, the result of, that cannot be inspected withoutdestroying or damaging the part. For example, welding, soldering, brazing,heat treatment, plating, some aspects of painting. All of these requiredestructive testing to assure testing.o Welding requires the weld to be pulled to destruction or cut and micro-

analyzed for integrity.o Heat treated parts require some sort of Rockwell-type test or a micro-

analysis.o Plating requires micro-analysis and possibly corrosive environment

testing.o Painting, to test for adhesion, may require scoring with a razor blade and

tape application/removal.

In these cases, the control must be on process parameters, including processcontrols, training of personnel, special records.

AS9100B requires that all such special processes be qualified and approvedprior to use (for production). This may require NADCAP certification.

AUDIT GUIDANCE

Review the manufacturing processes. Determine if there are any specialprocesses usedwithin the organization or outsourced.

Review the records foro Qualification of the process(es)o Qualification of personnelo Records of process and/or product tests.

Determine if there are any outsourced special processes. If so, review therecords for qualification of the supplier, control imposed by the organization,inspection records, corroboration testing as applicable, NADCAP.

In either case, if changes have been made to the process, determine ifsubsequent process and product re-qualification meets all applicable contractrequirements.


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REQUIREMENT

7.5.3& a-d IDENTIFICATION AND TRACEABILITY:

SUMMARY

It is not uncommon for a customer to purchase similar products at differentconfiguration levels. When this occurs, it is incumbent upon the organizationto maintain separation and control of the differing configuration levels.

Use of stamps, etc, to indicate acceptance of processes or products iscommon in the aerospace industry. Such media need to be controlled topreclude misapplication and misuse, including use by unauthorizedpersonnel.

As applicable, traceability is very important. The primary purpose is tominimize the size of a recall should such action become necessary. In theabsence of traceability, all product produced becomes suspect.o Items a-d spell out specific requirements, and are self-explanatory.

AUDIT GUIDANCE

Start with contract review.o Determine what configuration levels have been ordered.o Determine what level of traceability is required.

Review records of product shipped and in-process for conformance totraceability requirementso Pay particular attention to material or batch controls to be sure all such

material has been accounted for.

If an assembly is involved, ask for a bill of material. Verify that allcomponents and, if applicable, manufacturing processes, have requiredrecords and that the records verify conformance of shipped product.


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REQUIREMENT

7.5.5a-f PRESERVATION OF PRODUCT:

SUMMARY

These requirements address the critical need to maintain the integrity ofproduct after manufacture through all phases of the delivery process.

There is special emphasis on the prevention, detection and removal of foreignobjects.

Shelf life has to do with expiration dates of product or material. If applicable,these shall be clearly marked and adhered to. FIFO (first-in, first-out) is oneway to minimize problems with shelf life.

Hazardous materials typically require special marking, packing, andpackaging. They may also require special transportation modes.

AUDIT GUIDANCE

Review the contract for the presence of special, post-manufacturingrequirements associated with identification, packing, packaging.

If there are special requirements, assess for conformance to theserequirements.

If there are no special requirements, exercise good judgment regarding theorganizations approach to these issues determine if the product will beshipped and received as intended.

Pay special attention to how well shipping documents, and other documents

required for inclusion with the shipment, are identified and protected. Review process routers to assure that cleanliness, foreign objects, etc. are

addressed within the process.


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REQUIREMENT

7.6 & f CONTROL OF MONITORING AND MEASURING DEVICES:

SUMMARY

AS9100B gets very specific regarding the nature of instruction documentationrequired for a compliant gage calibration system.

Gages need to be listed, identified, located, have a defined frequency forcalibration, defined check method and acceptance criteria.

Additionally, the process for recalling gages (getting them into the calibrationfunction) needs to be defined.

AUDIT GUIDANCE

Review the organizations documented procedures and work instructions, asapplicable, for gage calibration.

Randomly select gages in use and in storage for further assessment; reviewthe records for these gages, checking for conformance.

Observe gages in-use. Look for unique identification and, as applicable, gagecalibration status identification.

Assess the adequacy of the environmental conditions where gages arecalibrated. Typically, gages capable of high discretion need more control,such as environmental stability, a defined soaking period, special handling.

In all cases, assess the adequacy of the masters to which gages arecompared with special attention to the traceability of such masters to

national standards. If gages are calibrated where they are used (that is, not taken to a calibration

room), assure that there is an adequate soaking time used for the master tobecome equalized to the ambient temperature.

If gages are in use at suppliers, assess the effectiveness of the recall system.If responsibility for the calibration of such gages is flowed down to thesupplier, assess the process whereby the organization assures the on-goingintegrity of such gages.


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REQUIREMENT

8.2.2 INTERNAL AUDIT:

SUMMARY

As stated earlier, the internal audit process is looking at the trees, that is, itis the process whereby the details of the organizations processes areassessed.

AS9100B has a requirement to take a disciplined approach to internal audits;reliance on checksheets and similar tools. This assumes an effectiveplanning process.

The organization is free to select and implement its own tools and approachto internal audits.

The internal audit process will be deemed effective if it discovers weaknessesprior to any negative affect on product. (Think of internal audits as a powerfulprevention tool.)

As has been seen throughout AS9100B, there is the admonition to pay strictattention to contract and/or regulatory requirementsif applicable.

AUDIT GUIDANCE

Review the documented procedure(s) for internal auditing; including the tools(e.g., checksheets, process flow diagrams) used by auditors.

Pay particular attention to the audit planning process, looking at frequency ofaudits, duplication of audits for high-impact/risk processes.

Assess the competency of internal audit personnel. Review audit records; look for schedule compliance and completion of all

checklist requirements.

Compare audit results to customer feedback documents, e.g., customercomplaints, product returns, etc.


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REQUIREMENT

8.2.3a-c MONITORING AND MEASUREMENT PROCESSES:

SUMMARY

The focus here is on process nonconformity, as opposed to productnonconformity.

Think of it this way: A design process could have a latent error; purchasingmay have issued a purchase order to the wrong design level; productionscheduling may have issued manufacturing documents that contain errors;etc. Any one of these may result in product nonconformities, but the causewas a nonconforming process.

Processes that are found to be nonconforming must be corrected.

When a nonconforming process is identified, the possibility/probability of thenonconformity resulting in product nonconformity must be assessed. Actionsmay include: design review, dimensional inspection, visual analysis,laboratory analysis, inventory review or product recall (worst case), just toname a few.

If nonconforming product is identified, it must be identified and controlled inaccordance with the organizations procedures and the requirements of clause8.3. The customer may need to be notified, especially if they are designresponsible and in charge of the airworthiness certificate.

AUDIT GUIDANCE

Process failures can be detected in a variety of ways, including internalaudits, in-process inspection, analysis of returned product, customercomplaints.

Review records for all of these potential inputs. Pay particular attention to theactions taken, especially action to prevent recurrence of the problem.

If product was involved, assess the effectiveness of actions taken to identifyall suspect product, including containment actions and subsequent actions todeal with the product, such as scrap, rework (in accordance with approvedprocedures), repair (in accordance with approved procedures), subsequentre-qualification of such product. Actions may also include a recall, dependingupon the severity of the problem and input from the customer.


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REQUIREMENT

8.2.4 MONITORING AND MEASUREMENT OF PRODUCT:

SUMMARY

There is emphasis on key characteristics; this does not preclude monitoringand control of other, non-key characteristics.

Sampling plans shall have statistical validity. The acceptance number shallalways be zero.

Inspection activities need to be completed as planned. In those cases wheresuch inspection must be delayed, processing through subsequent processesmay proceed provided it is done such that positive-recall must be assured;this does not include shipping to the customer unless previous approvals areobtained on a case-by-case basis.

AUDIT GUIDANCE

Determine if there are any key characteristics defined. If so, assess thecontrol processes for adequacy and effectiveness.

If sampling is used, ask to see the statistical evidence that the sampling planhas statistical validity (look at OC and AOQ curves). In all cases, theacceptance number (C) must be zero.o Determine if the customer requires approval of sampling plans. If so, is

there evidence of this approval?

If practicable, observe a process (or processes) where sampling is being

used. Review the organizations procedure for positive recall of in-process product

control.

Determine if there have been any instances where this procedure was used.If so, assess the controls used to assure that no nonconforming productreached the customer.


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REQUIREMENT

8.2.4.1a-d+ INSPECTION DOCUMENTATION:

SUMMARY

Required inspection actions must be documented. It may be done onseparate inspection instructions, or it may be incorporated in to the productiondocumentation, e.g., routers, travelers, etc.

Such instructions must define criteria for acceptance or rejection. Fordimensional characteristics, this is the nominal value and the associatedtolerance. For visual characteristics, there should be approved (controlled)visual standards. For performance characteristics, there should be definedconditions and results.

Instructions must define where and when inspections take place.

Inspection results must be recorded, and include a-d above.

Gages, etc., shall be defined, and, as required, special instructions forapplication and use.

AUDIT GUIDANCE

Determine how the organization conveys inspection instructions and criteria.

Audit actual inspection operations against these instructions.

Observe for correct implementation, records, and actions as warranted.

Assess the effectiveness of the conveyance/communication for acceptanceand rejection criteria.

If visual standards are required, determine if they are controlled to the extentnecessary to ensure their continued validity.

If special gages or other test equipment is used, determine if associatedinstructions are adequate to ensure that only conforming product is accepted.Note that even routine gages (e.g., calipers, micrometers) may have specialapplication instructions, such as where on the part to apply the gage.


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REQUIREMENT

8.2.4.2 FIRST ARTICLE INSPECTION:

SUMMARY

New parts require a first article inspection.

Depending upon the nature of the part, this may be as simple as adimensional inspection (full 100% layout) or as complex as to includechemical analysis, performance testing, or other related tests. (AS9102 maybe a requirement.)

If there are subsequent changes, the first article inspection needs to berepeated. Typical changes include engineering changes, significantmanufacturing process changes, and new suppliers.

AUDIT GUIDANCE

Randomly select a group of part numbers being produced by theorganization.

Ask for the first article records for each of these parts. This may require theretention of the actual part used for the first article inspection.

Determine if there have been any changes made to the part, or if there havebeen any significant manufacturing process or supplier changes.

If so, ask for records of the first article inspection action used to validate thechanges.

As applicable, are the requirements of AS9102 met?


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REQUIREMENT

8.3 CONTROL OF NONCONFORMING PRODUCT:

SUMMARY

Nonconforming product, by its very nature, requires a lot of attention andcontrol.

The organization must define its process for reviewing and dispositioningsuch product.

This is typically done via use of a Material Review Board, typically consistingof engineering, quality and customer-representative personnel. (Others maybe included.)

Personnel participating in such actions must have qualification andcompetency for the actions they take.

Use-as-is or repair are not acceptable disposition categories unless priorapproval is received from the customer.

There are some exceptions to this. For instance, a stamped part may berejected for excessive burrs. Such parts can typically be repaired by somenon-standard de-burring operation. Such actions are acceptable provided theresulting product does not deviate from contract requirements.

AUDIT GUIDANCE

Review the organizations documented procedure for controllingnonconforming product.

Review records to determine if these procedures are being adhered to. Review all disposition decisions. If use-as-is or repair has be used,

determine if such actions were taken with customer approval or, if not, if theactions taken did not result in product that deviated in any way from contractrequirements.


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REQUIREMENT

8.3 (contd.) CONTROL OF NONCONFORMING PRODUCT:

SUMMARY

Scrap control is very important to AS9100B certification. The intent is topreclude inadvertent use by the organization or by unscrupulous scraphandlers. In other words, there must be absolute assurance that scrap partsnever find their way in to aircraft.

Scrap must be identified in conspicuous and permanent manners, followed byactions to make it absolutely unusable.

Should an organization inadvertently ship nonconforming product, it has aresponsibility to notify all applicable customers. Timely is not specificallydefined, but is usually interpreted as hours, not days.

Such notification requires conveyance of all required descriptive information.

AUDIT GUIDANCE

Review the organizations procedure for scrap control.

Observe how scrap is handled, marked, and ultimately rendered unusable.

Determine if there have been any instances where the organization realizedthat nonconforming product had been inadvertently shipped to a customer. Ifso, review the records to determine if actions taken were adequate to assurethat all nonconforming product was accounted for and properly dispositioned.

Determine if such notification was timely.

Determine if any special customer directions were followed.


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Obtained From SQA Difference Between Iso 9001 and as 9100

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