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3.4.2 Are the specification required parameters for the complete heat treatment cycle including, but not limited to: soak times, soak temperatures, quench media, quenchant temperature (as applicable), atmosphere or vacuum requirements, furnace class, instrumentation type, etc., and any applicable tolerances for the above, listed on the specific job planning document for the part number, or easily referenced in a controlled system? YES/NO 3.5 Change Control 3.5.1 When customer approved fixed processes are required, is the Supplier working to the same process as approved by the Customer and is the evidence of this approval on file? YES/NO 3.5.2 When a process change is requested, is the customer notified and is the change approved by the customer prior to implementation? YES/NO/NA 3.6 Purchasing 3.6.1 Are all facilities used for subcontracted testing and processing approved by the OEM Customer, as required? YES/NO/NA 3.7 Process Validation 3.7.1 Does the supplier have a formal detailed procedure (P) that defines the process validation requirements, including: 3.7.1.1 (P) A methodology that meets applicable Regulatory and Customer - OEM requirements? YES/NO 3.7.1.2 (P) A requirement for a Validation Master Plan which is reviewed and updated, as necessary, at pre-defined frequencies? YES/NO Note: Equipment Qualification (IQ/OQ) and Process Qualification (PQ) shall be included in the Master Validation Plan for validated processes. 3.7.1.3 (P) Changes, such as new product introduction, new processes, new or modified equipment, or process changes, are assessed for risk and validation requirements, which may include the need to validate or revalidate? YES/NO 3.7.1.4 (P) A description of conditions that cause a process validation be completed? YES/NO 3.7.1.5 (P) A requirement that acceptance criteria is established prior to execution of the validation? YES/NO 3.7.1.6 (P) A requirement for a sampling plan that demonstrates capability of the process as well as the rationale for that selected sample size?. YES/NO/NA Auditor Handbook: NA would be acceptable if customer determines the sampling size and the Supplier/Contract Manufacturer accepts that sampling size for adequacy of demonstrating their confidence in consistently producing the part 3.7.1.7 (P) A requirement to define process parameter ranges, such as process extremes (e.g., worst case), and testing documentation to confirm those ranges will produce acceptable quality product or services. Examples might include: setup conditions, operating ranges, sequence, material handling requirements, etc. YES/NO Auditor Handbook: “Worst Case (e.g. maximum load)” is a combination of variables that will provide the most difficult challenge to the process, ensuring a quality outcome. 3.7.1.8 (P) A risk control mitigation procedure for product and processes (e.g., pFMEA)? YES/NA 3.8 Compliance (C) 3.8.1 (C) Is there evidence that the applicable Regulatory and Customer - OEM requirements are being met? YES/NA 3.8.2 (C) Is there evidence that a Validation Master Plan is reviewed and updated, as necessary, at |
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