Obtained From SQA Difference Between Iso 9001 and As 9100

Presents
Quality Management System Aerospace Requirements Differences between ISO 9001:2000 and AS9100B
John R. Sedlak January 2006
(Revised August 2006) (Revised May 2013)
Smithers Quality Assessments, Inc. | 425 West Market Street | Akron, OH 44303 | 1-866-688-0134 www.smithersregistrar.com
Differences between ISO 9001:2000 and AS9100B 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 ISO 14001 ISO/TS 16949 AS 9100 ISO 13485 OHSAS 18001 Quality Environmental Automotive Aerospace Medical Device Health & Safety
Additional services include: 1st Party Internal Audits Gap Analysis GMP (Good Manufacturing Practices) GLP (Good Laboratory Practices) 2nd Party 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.
Provided by: Smithers Quality Assessment, Inc. | 425 West Market St. | Akron, OH 44303 1-866-688-0134 | www.smithersregistrar.com
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Differences between ISO 9001:2000 and AS9100B Introduction: The material contained in this paper is intended for organizations that wish to comply with the requirements of AS9100B and personnel who are engaged in auditing the requirements. 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 make reference to contract requirements and/or regulatory authorities. In such cases, it is mandatory to first refer to the contract and, as applicable, regulatory requirements 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: Requirement o The clause and/or sub-clause number containing the differences is listed, along with a summary of the subject applicable subject matter. For the full text of the requirements, the reader will need to refer to the copyrighted version of AS9100B. Copies of AS9100B can be obtained from: SAE World Headquarters 400 Commonwealth Drive Warrendale, PA 15096-0001 USA Phone: 724-776-4841 www.store.sae.org Summary o 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 Guidance o These are suggested audit techniques and considerations, which have been reviewed by qualified AS9100B auditors. They are in no way meant to be all-inclusive. Each circumstance will have its own unique set of considerations. As always, an effective audit relies heavily on the experience and knowledge of the auditor.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 1 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 exclusions do not affect the organizations ability, or responsibility, to provide product or service 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 be included 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 various organizational processes and included in all certification activities. SCOPE:
AUDIT GUIDANCE No special guidance is required for qualified auditors. All applicable elements and organizational processes must be subjected to assessment both for initial and recertification assessments; sampling of these organizational 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 between the various locations.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 3.4.2 PRODUCT:
SUMMARY This is a basic definition of product, with emphasis on aerospace industry considerations. 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 quality management 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 byproducts of the process may enter into a certification decision. However, it will be under the requirements of ISO 14001, not AS9100.
AUDIT GUIDANCE The scope statement that will ultimately be stated on the certificate is very important. It must define the products and/or services being supplied by the organization, and the general processes used to produce and deliver them. It must 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 been documented; determine if the documented QMS fully encompasses the products and/or services provided by the organization. Early in the assessment process, determine if the QMS and environmental management system (EMS) are integrated. If they are, the audit team will need someone that is qualified for EMS.
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Differences between ISO 9001:2000 and AS9100B 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 business organizations. Requirements ultimately start with customers. Organizations supply products, often using the services of suppliers.
AUDIT GUIDANCE For the most part, these terms will be audited as part of the overall assessment process, perhaps with emphasis on the purchasing and design processes (if applicable at the site being assessed).
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 3 KEY CHARACTERISTICS:
SUMMARY The term key characteristic is not unique to aerospace, but it does have a high 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 and processes. Safety is often a consideration when designating key characteristics. It is common for some sort of symbol to be used to highlight or designate key characteristics. Key characteristics can be designated by the customer or by the organization. As applicable, the existence of key characteristics must be communicated to all applicable personnel, including suppliers. (Refer to configuration management.) Key characteristics often have special controls associated with them, e.g., SPC, special records and/or tests, special tools, special training for applicable personnel.
AUDIT GUIDANCE Review the organizations quality documentation and/or engineering documentation (product and/or process) to determine: a) how key characteristics are determined, b) how they are designated, c) how they are communicated, and d) how they are controlled. Review working documents to see if key characteristics are clearly communicated, as applicable. Review records for those key characteristics that have special controls defined. Review performance to verify that these key characteristics are reviewed at the frequency required.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 4.2.1f SUMMARY It is not uncommon for customers and/or regulatory agencies to pass down requirements to organizations. Whenever this occurs, it is required that the organization develop methods for including such requirements in its documented quality management system. There are many specific requirements that could be passed down. Some examples are: o Requirement for specific non-destructive evaluation. o Requirements to use specified suppliers. o Special labeling requirements. GENERAL:
AUDIT GUIDANCE Examine customer purchase orders. Look for specific requirements that may be passed down. If requirements are passed down, verify that they have been included within the documented QMS. Request that the organization provide you with documents from regulatory agencies (e.g., FAA) that have requirements applicable to the organization and/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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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 4.2.2b SUMMARY Generally, in ISO 9001 systems, it is not required to make direct linkage or reference 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 the standard as well as those that the organization determines to be necessary. QUALITY MANUAL:
AUDIT GUIDANCE During the document review phase of the assessment, and during the assessment of all changes to the QMS, pay particular attention to how the organization has met this requirement. There are various methods to meet this requirement, such as: o Inclusion of the ISO 9001 clause reference in each procedure o 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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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 4.2.3 g. SUMMARY This is a requirement aimed at keeping those that have a need-to-know informed. The purpose is to prevent unintended consequences. CONTROL of DOCUMENTS:
AUDIT GUIDANCE If the organization maintains a change log, as part of each assessment activity, review it for the documents comprising the AS9100B QMS. Ascertain if customers and/or regulatory bodies have been notified of such changes. If not, 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 the organization controls changes to documents how the changes are coordinated with customers and/or regulatory authorities.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 4.2.4 SUMMARY The first added requirement emphasizes controlling records that are created or retained by suppliers. Remember, suppliers provide organizations with materials, components, products or services. o Records could include traceability documents, certificates of inspection, testing, analysis, SPC data, and other such documents. o There is special emphasis on records that are created and retained by suppliers. This requires the organization to specify or pass down requirements to suppliers regarding control of such records. Control may include items like a list of records to be controlled, storage, accessibility, change authorization (or forbidden to make changes), and disposal The second added requirement addresses the need to make records available to customers and regulatory authorities in accordance with contract or regulatory requirements. o This does not mean that customers and/or regulatory authorities have access to all records within an organization; only to those specified in the contract or defined in applicable regulations. CONTROL OF RECORDS:
AUDIT GUIDANCE There is a heavy emphasis on creation and control of records in the aerospace industry. Ascertain how the organization has determined what records are required. This could be self-determined or as defined by the customer in the contract or by applicable regulations. Review the controls as defined in the organizations documented procedures. Determine which records are to be controlled by suppliers. Determine how the organization has passed down the requirements to the supplier. Contact a random selection of suppliers and determine if records are being controlled as defined by the organization, or as required by the customer and/or regulatory authority.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 4.3 SUMMARY Configuration management involves control of all documents that pertain to the 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 of components. Another aspect deals with existing inventory and product in the field. o A sub-category of this, as warranted, may be product recall. CONFIGURATION MANAGEMENT:
AUDIT GUIDANCE Start with a review of the process the organization has defined regarding configuration 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 configuration management program has addressed them as applicable and appropriate.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 5.5.2 SUMMARY In aerospace focused manufacturing, there is a need to have at least one person inside the organization that, in a very real sense, has the authority to speak for the customer or regulatory authority. This person must be the management representative (MR) as a minimum. Having organizational freedom means that this person does not need to seek authority for each action on a case-by-case basis. Rather, the MR is authorized to take action that is binding upon the organization period! MANAGEMENT REPRESENTATIVE:
AUDIT GUIDANCE Review the quality documentation and determine how the authority of the MR is 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 this requirement. 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 there is true organizational freedom.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.1 e SUMMARY ISO 9001:2000 does not get specific regarding maintenance, whereas AS9100B does. Resources includes personnel, equipment, repair parts, tooling and/or machine repair and maintenance facilities (may be internal or external). PLANNING OF PRODUCT REALIZATION:
AUDIT GUIDANCE Interview personnel in the maintenance department. Ascertain their level of competence. Review the organizations inventory of repair parts, tools, etc. Review the organizations maintenance and/or tool repair facilities. If either of these is outsourced, pay particular attention to the controls established by the organization to assure that product continues to meet all requirements. Review maintenance and/or tool repair records. Look for evidence of postaction 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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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.2.2d SUMMARY In essence, this requirement says: Dont just take the order. There is a defined requirement to recognize risks, analyze their potential impacts, 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. REVIEW OF REQUIREMENTS RELATED TO PRODUCT:
AUDIT GUIDANCE Review evidence of contract review processes/actions. Determine how the organization goes about identifying potential risks, actions taken, level of customer involvement. Review records of such actions, including customer inputs and/or responses.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.3.1a SUMMARY The emphasis is on the planning process for design. Questions: Are there sufficient trained and competent personnel? What are the sequential steps for design activities? Of these steps, which are mandatory and significant? (E.g., validation testing, change approval, prototyping.) Has there been any assignment(s) to other personnel in the organization? Configuration control is a key consideration (see 4.3). DESIGN AND DEVELOPMENT PLANNING:
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 planning steps. Determine if the organization has executed effective configuration control. (4.3)
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.3.1c SUMMARY Design projects run the range from very simple (one component) to very complex (space shuttle). The organization must make a good-faith effort to classify new projects to the appropriate level of complexity. As complexity increases, there will be increasing needs to assure that responsibilities, authorities, and other key design considerations are defined and controlled. Emphasis is on personnel, design input, constraints and performance conditions. Throughout, the design process must assure that contract requirements are met. There is added emphasis on safety and functional objectives of the product. DESIGN AND DEVELOPMENT PLANNING:
AUDIT GUIDANCE Same as 7.3.1a Review the process used by the organization to determine the project complexity. 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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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.3.3e SUMMARY In essence, this is an example of configuration management. (4.3) The emphasis is on the finished product. DESIGN AND DEVELOPMENT OUTPUTS:
AUDIT GUIDANCE Review the output documents of a design project. Determine if there is clear and adequate definition of the product and all related 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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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.3.4 SUMMARY This requirement is focused on personnel that have defined authority to permit 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, customer involvement. DESIGN AND DEVELOPMENT REVIEW:
AUDIT GUIDANCE Determine how the organization has designated those personnel with defined authority to permit design processes to proceed through the various steps. Look for records that verify that such authority was exercised at the appropriate design steps/phases. Determine if review has been limited to design personnel. If other departments/functions have not been included, it may be that problems will occur in the manufacturing process.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.3.6.1 DOCUMENTATION OF DESIGN VARIFICATION AND VALIDATION: AND/OR DEVELOPMENT
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 that exists to show that all requirements have been met. There is emphasis on product meeting requirements throughout identified operational 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 actions the 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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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.3.6.2 DESIGN AND/OR DEVELOPMENT VERIFICATION AND VALIDATION TESTING:
SUMMARY The emphasis is on control of all aspects of verification and validation testing. In a few words: be sure the correct product, at the correct revision level and status, is being tested; the test method is defined and adhered to; results are recorded; test results meet defined requirements.
AUDIT GUIDANCE Review the documentation defining verification and validation testing requirements. 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 agencies involved?
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.3.7 SUMMARY Changes are very important to all aspect of aerospace manufacturing. It is not uncommon for contracts to have defined requirements for customer and/or regulatory authorities to reserve authority for all changes. Even if an organization is design responsible, there may be contract or regulatory 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. CONTROL OF DESIGN AND DEVELOPMENT CHANGES:
AUDIT GUIDANCE Review contract requirements. If there are contract requirements for customer and/or regulatory authority involvement in design and development changes, ascertain if the organization is adhering to the defined requirements.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.4.1a-e 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 of responsibility for controlling the quality from such suppliers. All suppliers are to be approved via an organization -defined process; this includes a disapproval process and defined authority for all such actions. There is special emphasis on out-sourced special processes, such as welding, plating, Non-destructive Evaluation (NDE), etc. There may be customer approval required for outsourced work. There may be NADCAP approval required for special processes. PURCHASING PROCESS:
AUDIT GUIDANCE Review contracts, engineering requirements, part drawings. Determine if there are any customer-designated suppliers, or if there is a requirement for customer approval of suppliers. Review the receiving and in-process inspection records that pertain to these suppliers; check for incoming and in-process conformance. If the organization has a defined supplier control process that involves supplier on-site evaluations, review records. Compare supplier records to the approved-supplier list. Determine that all belong on the approved list. Look at corrective action requests issued to suppliers. Determine if action is appropriate and effective. Review supplier performance data. Determine, as applicable, if NADCAP or customer approval was obtained.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.4.2d-j SUMMARY The overriding theme of this list of requirements is communication of important 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 event of a problem. Suppliers are not to change product or manufacturing processes without first informing the organization. Right of access to suppliers (and, as applicable, to sub -tiers) facilities and applicable records is required; applies to the organization, customers and regulatory authorities If supplier purchase from lower tiers, they have a responsibility to pass-down applicable requirements and controls. PURCHASING INFORMATION:
AUDIT GUIDANCE Start with the contract and engineering documents. Determine what is being purchased. Review purchasing documents to determine if all of these requirements are being met in the documented quality management system as well as in practice; verify all flow down requirements. Pay special attention to those cases where suppliers are purchasing from sub-tiers.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.4.3a-e SUMMARY This requirement provides a list of acceptable methods for supplier-provided product 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 effectively prevents 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 validated typically by the organization or an outside laboratory. Delegation is a highly visible process, not to be taken lightly. Those that are granted delegated authority must be competent and be granted authority for unencumbered decision making. As warranted by contract, customers and their representative must be able to verify product at suppliers prior to use by the organization. Such verification shall not be used by the organization as evidence of acceptance that is, the organization retains it own responsibility to verify conformance of purchased product even if the customer has pre-inspected it and found it to be acceptable. VERIFICATION OF PRUCHASED PRODUCT:
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 the person(s) to whom authority has been delegated; review the list of delegations. Review purchasing documents to determine how suppliers are informed of their 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 its defined verification controls.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.1 SUMMARY A control plan lists the methods used at each operation to assure conformance of product (e.g., gages, frequency, records, SPC, operations, actions to take if nonconforming product is identified); required for key characteristics. If product transformation actions make inspection impossible, upstream controls 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. CONTROL OF PRODUCTION AND SERVICE PROVISION:
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 prevent the production of (or at least the flow of) nonconforming product.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.1g-k SUMMARY This requirement addresses the need to account for all material from start to finish to preclude the occurrence of nonconforming product being shipped to the customer. Consideration given to split lots duplication of applicable paperwork, configuration control, especially of non-used product is placed back into inventory. The prevention damage from the presence of foreign objects is of high importance in aerospace work. (FOD = foreign object damage.) Foreign objects 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 from nonconforming. If representative samples are used, they need to be controlled in a manner similar to gages. CONTROL OF PRODUCTION AND SERVICE PROVISION:
AUDIT GUIDANCE Assess the effectiveness of the organization to account for all material and parts from start to finish; special emphasis on split lots, reworked or repaired product (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 executed after the split has been documented, e.g. routers updated or annotated, inspection sheets, test reports, etc.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.1.1 SUMMARY Production operations shall be executed in such a manner that all personnel have available to them correct and current data. Part of this control includes the listing of required tooling and, as applicable, numerical control information. PRODUCTION DOCUMENTATON:
AUDIT GUIDANCE Review the documentation that accompanies product through the manufacturing processes. Determine if this documentation is sufficient to assure conforming product at all phases of manufacturing. If NC controls are in place, determine if they are controlled to the extent necessary to assure current, conforming product. If NC controls are in place, determine if the same version of the NC program has been used on all parts in the lot. If not, was there a review of this action and were results acceptable?
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.1.2 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 process change. If a process is changed, the effect on the resultant product must be evaluated to validate continued conformance. o This may include changes to NC programs. CONTROL OF PRODUCTION PROCESS CHANGES:
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 for resultant product.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.1.3 CONTROL OF PRODUCTION EQUIPMENT, TOOLS AND NUMERICAL CONTROL (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 documented procedures.
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 storage assess for effective protection. Determine how the organization verifies that tooling held in storage is determined to be current prior to each use, that is, as applicable, it has been updated to meet current design revision levels. Determine if changes or modifications to NC programs required a new firstarticle. If so, was it done?
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.1.4 CONTROL OF WORK TRANSFERRED ON A TEMPORARY BASIS, OUTSIDE THE ORGANIZATIONS FACILITIES:
SUMMARY On occasion, organizations may find it necessary to outsource one or more of its standard manufacturing processes. (This is different from purchasing product.) If this occurs, the organization must develop/define effective controls to assure that only conforming product reaches the customer.
AUDIT GUIDANCE Determine if the organization has had any occurrences of outsourcing one or more of its manufacturing processes. Determine how the organization qualified the source. Evaluate the effectiveness of the controls put in place by the organization to assure that only conforming product reaches the customer. Pay particular attention to the required paperwork, e.g., routers, inspection sheets, firstarticle documents. Is this flowing to the outsourced organization as required? Does it come back with the product?
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.1.5 SUMMARY Service typically occurs after delivery. It differs from warranty work. Since service activities have the potential to effect product quality, they are expected to have equal, and sometimes more, control than the original manufacturing processes. Servicing often involves working with multiple revision levels read, configuration control. CONTROL OF SERVICE OPERATIONS:
AUDIT GUIDANCE Determine if the organization has contractual requirements for post-delivery service. If yes, determine how the organization assures conformance at the required product 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 is reviewed and used by the organization.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.2a & c VALIDATION OF PROCESSES FOR PRODUCITON AND SERVICES PROVISION:
SUMMARY Special processes are those, the result of, that cannot be inspected without destroying or damaging the part. For example, welding, soldering, brazing, heat treatment, plating, some aspects of painting. All of these require destructive testing to assure testing. o Welding requires the weld to be pulled to destruction or cut and microanalyzed for integrity. o Heat treated parts require some sort of Rockwell-type test or a microanalysis. 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 process controls, training of personnel, special records. AS9100B requires that all such special processes be qualified and approved prior to use (for production). This may require NADCAP certification.
AUDIT GUIDANCE Review the manufacturing processes. Determine if there are any special processes used within the organization or outsourced. Review the records for o Qualification of the process(es) o Qualification of personnel o Records of process and/or product tests. Determine if there are any outsourced special processes. If so, review the records 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 if subsequent process and product re-qualification meets all applicable contract requirements.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.3& a-d SUMMARY It is not uncommon for a customer to purchase similar products at different configuration levels. When this occurs, it is incumbent upon the organization to maintain separation and control of the differing configuration levels. Use of stamps, etc, to indicate acceptance of processes or products is common in the aerospace industry. Such media need to be controlled to preclude misapplication and misuse, including use by unauthorized personnel. As applicable, traceability is very important. The primary purpose is to minimize the size of a recall should such action become necessary. In the absence of traceability, all product produced becomes suspect. o Items a-d spell out specific requirements, and are self-explanatory. IDENTIFICATION AND TRACEABILITY:
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 to traceability requirements o 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 all components and, if applicable, manufacturing processes, have required records and that the records verify conformance of shipped product.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.5.5a-f SUMMARY These requirements address the critical need to maintain the integrity of product after manufacture through all phases of the delivery process. There is special emphasis on the prevention, detection and removal of foreign objects. 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 one way to minimize problems with shelf life. Hazardous materials typically require special marking, packing, and packaging. They may also require special transportation modes. PRESERVATION OF PRODUCT:
AUDIT GUIDANCE Review the contract for the presence of special, post-manufacturing requirements associated with identification, packing, packaging. If there are special requirements, assess for conformance to these requirements. If there are no special requirements, exercise good judgment regarding the organizations approach to these issues determine if the product will be shipped 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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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 7.6 & f SUMMARY AS9100B gets very specific regarding the nature of instruction documentation required for a compliant gage calibration system. Gages need to be listed, identified, located, have a defined frequency for calibration, defined check method and acceptance criteria. Additionally, the process for recalling gages (getting them into the calibration function) needs to be defined. CONTROL OF MONITORING AND MEASURING DEVICES:
AUDIT GUIDANCE Review the organizations documented procedures and work instructions, as applicable, for gage calibration. Randomly select gages in use and in storage for further assessment; review the records for these gages, checking for conformance. Observe gages in-use. Look for unique identification and, as applicable, gage calibration status identification. Assess the adequacy of the environmental conditions where gages are calibrated. 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 are compared 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 to become 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 the supplier, assess the process whereby the organization assures the on-going integrity of such gages.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 8.2.2 SUMMARY As stated earlier, the internal audit process is looking at the trees, that is, it is the process whereby the details of the organizations processes are assessed. AS9100B has a requirement to take a disciplined approach to internal audits; reliance on checksheets and similar tools. This assumes an effective planning process. The organization is free to select and implement its own tools and approach to internal audits. The internal audit process will be deemed effective if it discovers weaknesses prior to any negative affect on product. (Think of internal audits as a powerful prevention tool.) As has been seen throughout AS9100B, there is the admonition to pay strict attention to contract and/or regulatory requirements if applicable. INTERNAL AUDIT:
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 of audits, 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., customer complaints, product returns, etc.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 8.2.3a-c SUMMARY The focus here is on process nonconformity, as opposed to product nonconformity. Think of it this way: A design process could have a latent error; purchasing may have issued a purchase order to the wrong design level; production scheduling may have issued manufacturing documents that contain errors; etc. Any one of these may result in product nonconformities, but the cause was a nonconforming process. Processes that are found to be nonconforming must be corrected. When a nonconforming process is identified, the possibility/probability of the nonconformity resulting in product nonconformity must be assessed. Actions may include: design review, dimensional inspection, visual analysis, laboratory analysis, inventory review or product recall (worst case), just to name a few. If nonconforming product is identified, it must be identified and controlled in accordance with the organizations procedures and the requirements of clause 8.3. The customer may need to be notified, especially if they are design responsible and in charge of the airworthiness certificate. MONITORING AND MEASUREMENT PROCESSES:
AUDIT GUIDANCE Process failures can be detected in a variety of ways, including internal audits, in-process inspection, analysis of returned product, customer complaints. Review records for all of these potential inputs. Pay particular attention to the actions taken, especially action to prevent recurrence of the problem. If product was involved, assess the effectiveness of actions taken to identify all suspect product, including containment actions and subsequent actions to deal with the product, such as scrap, rework (in accordance with approved procedures), repair (in accordance with approved procedures), subsequent re-qualification of such product. Actions may also include a recall, depending upon the severity of the problem and input from the customer.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 8.2.4 SUMMARY There is emphasis on key characteristics; this does not preclude monitoring and control of other, non-key characteristics. Sampling plans shall have statistical validity. The acceptance number shall always be zero. Inspection activities need to be completed as planned. In those cases where such inspection must be delayed, processing through subsequent processes may proceed provided it is done such that positive-recall must be assured; this does not include shipping to the customer unless previous approvals are obtained on a case-by-case basis. MONITORING AND MEASUREMENT OF PRODUCT:
AUDIT GUIDANCE Determine if there are any key characteristics defined. If so, assess the control processes for adequacy and effectiveness. If sampling is used, ask to see the statistical evidence that the sampling plan has statistical validity (look at OC and AOQ curves). In all cases, the acceptance 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 product reached the customer.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 8.2.4.1a-d+ INSPECTION DOCUMENTATION: SUMMARY Required inspection actions must be documented. It may be done on separate inspection instructions, or it may be incorporated in to the production documentation, e.g., routers, travelers, etc. Such instructions must define criteria for acceptance or rejection. For dimensional characteristics, this is the nominal value and the associated tolerance. For visual characteristics, there should be approved (controlled) visual standards. For performance characteristics, there should be defined conditions 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 for application 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 acceptance and rejection criteria. If visual standards are required, determine if they are controlled to the extent necessary to ensure their continued validity. If special gages or other test equipment is used, determine if associated instructions are adequate to ensure that only conforming product is accepted. Note that even routine gages (e.g., calipers, micrometers) may have special application instructions, such as where on the part to apply the gage.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 8.2.4.2 SUMMARY New parts require a first article inspection. Depending upon the nature of the part, this may be as simple as a dimensional inspection (full 100% layout) or as complex as to include chemical analysis, performance testing, or other related tests. (AS9102 may be a requirement.) If there are subsequent changes, the first article inspection needs to be repeated. Typical changes include engineering changes, significant manufacturing process changes, and new suppliers. FIRST ARTICLE INSPECTION:
AUDIT GUIDANCE Randomly select a group of part numbers being produced by the organization. Ask for the first article records for each of these parts. This may require the retention of the actual part used for the first article inspection. Determine if there have been any changes made to the part, or if there have been any significant manufacturing process or supplier changes. If so, ask for records of the first article inspection action used to validate the changes. As applicable, are the requirements of AS9102 met?
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 8.3 SUMMARY Nonconforming product, by its very nature, requires a lot of attention and control. The organization must define its process for reviewing and dispositioning such product. This is typically done via use of a Material Review Board, typically consisting of engineering, quality and customer-representative personnel. (Others may be included.) Personnel participating in such actions must have qualification and competency for the actions they take. Use-as-is or repair are not acceptable disposition categories unless prior approval is received from the customer. There are some exceptions to this. For instance, a stamped part may be rejected for excessive burrs. Such parts can typically be repaired by some non-standard de-burring operation. Such actions are acceptable provided the resulting product does not deviate from contract requirements. CONTROL OF NONCONFORMING PRODUCT:
AUDIT GUIDANCE Review the organizations documented procedure for controlling nonconforming 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 the actions taken did not result in product that deviated in any way from contract requirements.
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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 8.3 (contd.) SUMMARY Scrap control is very important to AS9100B certification. The intent is to preclude inadvertent use by the organization or by unscrupulous scrap handlers. In other words, there must be absolute assurance that scrap parts never find their way in to aircraft. Scrap must be identified in conspicuous and permanent manners, followed by actions to make it absolutely unusable. Should an organization inadvertently ship nonconforming product, it has a responsibility to notify all applicable customers. Timely is not specifically defined, but is usually interpreted as hours, not days. Such notification requires conveyance of all required descriptive information. CONTROL OF NONCONFORMING PRODUCT:
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 realized that nonconforming product had been inadvertently shipped to a customer. If so, review the records to determine if actions taken were adequate to assure that 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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Differences between ISO 9001:2000 and AS9100B REQUIREMENT 8.5.2g & h SUMMARY A documented procedure is required for corrective action. This procedure must contain specific actions and controls for those situations where it has been determined that suppliers are the source of the root cause of the nonconformance. There must be defined actions that address subsequent actions where the actions originally planned are not completed on time or are not effective. CORRECTIVE ACTION:
AUDIT GUIDANCE Review the documented procedure for corrective action. Determine if flow down to suppliers is addressed (in those cases where suppliers are determined to be the root cause of the nonconformance). Review records for corrective actions. Pay particular attention to: o Flow down to suppliers if applicable o Completion of planned corrective action within the defined timeframe. o Verification by the organization that actions taken were effective at correcting the problem and preventing recurrences. If corrective actions were not timely or effective, determine what additional actions the organization took to address this situation.
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