Changes in AS9100 Quality System Standard, Rev D
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Some of the changes in AS9100 include:
- Change management is now a part of the business culture to anticipate the consequences of change.
- Corrective and preventive actions have merged into one corrective action concept.
- Counterfeit parts are a growing threat to product and service conformity, which now requires a documented procedure for prevention management.
- Employees are required to be aware of product safety, ethical behavior and their contribution to product and service conformity.
- Industry reversed favor for C=0 Zero Acceptance Number Sampling Plan because its AQL is based upon percent rejectable rather then percent acceptable.
- Product and service support after delivery is now common practice.
- Project management is now mandatory.
- Retention and documentation of knowledge about how to operate the business is now required.
- Risk based thinking applies to all aspects of the business operation, not just the quality management system, and includes such things as consideration for product obsolescence due to advancing technology, product safety from receipt to delivery, and prevention of problems.
- The quality system management representative was eliminated by ISO 9001 but is required for AS9100.
- The requirement for a quality manual was eliminated.
- The root cause of nonconformities now requires evaluation of the Human Factor.
Quality Management System (QMS) Audit
The first step in implementing the QMS is to assure that the QMS is in compliance to all requirements including Customer specific requirements. This may be accomplished by using Internal Process Mapping.
The second step is to assure that the QMS is being followed. An example of this would be auditing procedures, work instructions, process maps, etc., at the defined frequency in the audit schedule.
The complete list of processes can serve as an audit check sheet to ensure the Company has covered the entire QMS. It is critical to verify the effectiveness of each process during the Quality Management System audit. The audit should include focus on Customer satisfaction metrics including but not limited to cost, quality, delivery, Customer disruptions, etc. The Manufacturing Process Audit and/or Product Compliance Audits may also be performed in conjunction with the QMS audit.
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