11 8 9 10 ObjectiveEvidence/Comments Item # Quality Management System Requirements C NCR (e.g., observations, OFIs) 8.5 Improvement 8.5.1 Continual improvement 389 The QMS is continually improved through the quality policy, quality objectives, audit results, analysis of data, corrective/preventive actions, and management reviews 390 Improvements and the evaluation of effectiveness are monitored 8.5.2 Corrective action (CA) 391 Actions are taken to eliminate the causes of nonconformities 392 A documented PROCEDURE exist that includes: Procedure ref.: 393 a. reviewing of nonconformities 394 b. determining the causes of nonconformities 395 c. evaluating action to prevent recurrence 396 d. determining and implementing actions 397 e. record of actions taken CA record(s) ref.: 398 f. reviewing the effectiveness of corrective actions 399 g. flowing down CA requirements to suppliers 400 h. actions where timely and/or effective CAs are not achieved 401 i. determining if additional NCP exists 402 j. evaluating action based on human factors (9110 only) 8.5.3 Preventive action (PA) 403 Actions taken to eliminate the causes of potential nonconformities 404 A documented PROCEDURE exist that includes: Procedure ref.: 405 a. determining potential nonconformities and their causes 406 b. evaluating action to prevent occurrence 407 c. determining and implementing action 408 d. record of actions taken PA record(s) ref.: 409 e. reviewing the effectiveness of PA 410 f. evaluating action based on human factors (9110 only) Auditor Name(s) Signature:
FORM INSTRUCTIONS APPENDIX A – OBJECTIVE EVIDENCE RECORD (OER) This form should be used during the “on-site” quality management system audits for recording the objective evidence that is used to determine conformity with the related QMS requirements. It can also be used to record auditor notes/comments and opportunities for improvement (OFI). NOTE: This OER summarizes the requirements and is not intended to add or take away from the stated requirements. Where a conflict exists, the stated requirement in the applicable standard takes precedence. 1 Include the name of the organization conducting the audit. 2 Include the logo of the organization conducting the audit (optional). 3 Identify name of organization audited as noted or to be noted on the certificate or approval. 4 Identify associated audit/audit report number. 5 Identify site, OASIS Identification Number (OIN), and location of the audited organization as noted or to be noted on the certificate or approval. 6 Indicate date the OER was completed. 7 Tick box(es) () of the applicable standard(s) (i.e., 9100, 9110, 9120). 8 Summarized requirement description. The description of the additional aviation, space, and defense requirements are shown as bold/italic text. All descriptions without bracketed standard reference are applicable for all standards: 9100, 9110, and 9120. Descriptions with a bracketed standard reference are applicable for the indicated standard only (e.g., item 18). ‘Documented safety policy and safety objectives (9110 only)’ is applicable to 9110 QMS only. 9 Conforming (C): Enter a mark: (X, S, , etc.) to indicate that the requirement was audited and found to be conforming. “N/E” to indicate not evaluated. “N/A” to indicate not applicable. “EX” to indicate an acceptable exclusion. In case of a nonconformity, leave conforming box blank to indicate a NCR and enter the NCR number in box 10. 10 Nonconformity Report (NCR): Record/reference the applicable NCR number. 11 ObjectiveEvidence/Comments/OFIs: Record objective evidence reviewed during the assessment and any applicable comments. The prefilled text in this column is for guidance and the objective evidence to be recorded should not be limited to these items. Typical examples of objective evidence are the documents reviewed, including records (e.g., procedures, shop orders/travelers, job descriptions, process sheets, training records, products, verification records). Comments associated to any observed concerns or improvement opportunities should also be included. NOTE 1: NOTE 2: The completion of this information could start during the Stage 1 phase (record of the quality manual and procedures), then be carried over to the on-site audit to record what was observed. If clause 7 of the applicable 9100-series standards and its sub-clauses are associated with processes that are addressed on a PEAR, the objective evidence can be mentioned in the PEAR. In such case, the PEAR number should be referenced in this column.