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pre-defined frequencies? YES/NO 3.8.3 (C) Is there evidence that 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/NA Note: NA applies only when no changes, such as those described above, have been implemented. 3.8.4 (C) Is there evidence that process validation is being done per the procedure? YES/NO 3.8.5 (C) Is there evidence that acceptance criteria were established prior to execution of the validation? YES/NO 3.8.6 (C) Is there evidence of a sampling plan that demonstrates establishment 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. 3.8.7 (C) Is there evidence that indicates by operating at worst case processing parameters the product will still meet all predetermined requirements? YES/NO Auditor Handbook: “Worst Case (maximum load)” is a combination of variables that will provide the most difficult challenge to the process, ensuring a quality outcome. 3.8.8 (C) Is there evidence that risk control mitigation is in place for product and processes (e.g., pFMEA)? YES/NO 4. PERSONNEL 4.1 Training 4.1.1 Are there training procedures that assure personnel performing heat treating and associated quality and test functions are competent to perform assigned tasks? YES/NO 4.1.2 Do records indicate that training is scheduled and attended in accordance with procedures and documented? YES/NO 4.2 Evaluation of Personnel 4.2.1 Do procedures require periodic evaluation to ensure that approved personnel maintain proficiency in their assigned heat treating and related tasks? YES/NO 4.2.2 Do records indicate that the evaluations are performed at documented frequencies and the results reviewed with employees? YES/NO 5. MATERIAL HANDLING AND TRACEABILITY 5.1 Incoming Material to Processing 5.1.1 Are identification, count and quality discrepancies resolved prior to processing of parts? YES/NO 5.1.2 Do procedures ensure that incoming customer documents remain traceable to those specific jobs throughout processing? YES/NO 5.1.3 When more than one production job is processed in a furnace at the same time, is traceability maintained for each production job processed? YES/NO/NA 5.2 General Cleaning 5.2.1 Does the internal procedure require that parts be clean prior to loading for processing in the furnaces? YES/NO 5.2.2 Do records indicate that the procedure is followed? YES/NO 5.3 Corrosion Resistant Steels Cleaning SECTION NA |
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