Applicable Documents to Audit [Business Unit Name] Business Unit Process Definition Document (QMS-FS-PRO-BU-001) 0

Transcription

1 STEP ONE: Audit Plan Process to Audit (Audit Scope): Audit Date(s): Audit #: Lead Auditor: Auditor(s): Site(s) to Audit: [Business Unit Name] Applicable processes of [Business Unit Name] Applicable Documents to Audit [Business Unit Name] Business Unit Process Definition Document (QMS-FS-PRO-BU-001) 0 Rev. NB: s in steps 2-4 relate to the Business Unit Process Definition Document (PDD) s at Appendix 1 relate to the Business Unit Process Flowcharts (PRFs) STEP TWO: Process Definition The following questions are relevant to the Process Definition Document (PDD) and Business Unit Manager Have all staff in the Business Unit received awareness training in the Quality Management System? Do procedures, instructions and forms accurately reflect the Business Unit practices? (Note: Requires auditor review and observation!) Are Business Unit objectives monitored for achievement? Is relevant customer feedback available? (Feedback from all Business Unit processes) Indicate any suggestions for improvement related to the PDD: 1. Page 1 of 6

2 STEP THREE: Process Resources Assessment of the adequacy of resources allocated to the Business Unit Are staff trained in the process inputs, activities and outputs relevant to the Business Unit activities? Is the equipment provided (e.g. tools, equipment; transport, logistics; hardware, software; PPE; etc.) adequate for its intended use? Is Business Unit equipment identified to allow participants to determine its readiness for safe use prior to and during operations? Are all staff aware of who their customers are and whether they are satisfied? Indicate any suggestions for improvement related to the resources: 2. Review previous audits for this Business Unit. Review previous CARs issued against this Business unit, or as a result of previous audits for the Business Unit processes. Add additional checklist questions here, based on the previous audits, CARs or other documents or requirements, as you see fit. Requirement Reference Evidence or Notes Sheet Ref. # Page 2 of 6

3 STEP FOUR: Process Monitoring Review the applicable procedure(s) for this process and answer the questions below. Have key performance indicators (KPI) been established to allow the effectiveness of the process to be evaluated? Are KPI reviewed and communicated to Senior Management by the Business Unit, as appropriate? Are the processes measured for efficiency? When a Business Unit process is not performing, is there evidence of data analysis to determine the root cause? Are records of Business Unit process monitoring reviewed regularly to determine opportunities for corrective and preventive action? Indicate any problems you uncovered with the processes: 3. Provide brief details on any areas that you found were well-implemented, particularly effective or worth noting as positive traits. Page 3 of 6

4 STEP FIVE: Summarize Findings for CAR system Based on the findings and nonconformities you have recorded in the previous sections, summarize the necessary actions needed. For type, choose one of the following: C =Corrective action needed (existing noncompliance) P = Preventive action needed (potential noncompliance) OFI = Opportunity for Improvement CAR # BU Process Describe finding as you want it to appear in the CAR system. Requirement: Type Major / Minor Evidence: Rationale for Finding: Requirement: Evidence: Rationale for Finding: Requirement: Evidence: Rationale for Finding: STEP SIX: Review Audit Report and Submit All auditors on the audit team must submit their audit reports for summary and review by the Lead Auditor. Lead Auditor: review the completeness of this report prior to submitting it to the F&S Management Representative. Be sure findings show objective evidence, that everything is written clearly, and that all checklist questions are answered. Audit report reviewed and ready for submission: Signature of Lead Auditor Date Page 4 of 6

5 NOTES PAGE Your Note reference # STEP TWO: Process Definition 1. Notes, evidence, findings, comments, etc. STEP THREE: Process Resources 2. STEP FOUR: Process Monitoring 3. Appendix 1: Business Unit Process Flow Chart (PRF) 4. Add an additional Appendix 1: Business Unit Process Flow Chart (PRF) Set for each PRF audited Page 5 of 6

6 Appendix 1: Business Unit Process Flow Chart (PRF) Set (Print this page for each process flow chart audited) set for Process Flowchart (QMS-FS-PRF-XX-YYY) F&S Division Compare the requirements of the Business Unit documentation against what employees are actually doing in everyday practice. Have procedures, instructions, and forms been established as needed to control the process? Are procedures, instructions and forms used in controlling the Business Unit process readily available? Is the process flow constructed to avoid unnecessary movement of materials and personnel? Are redundant and non-value adding activities minimized? Are process outputs passed on to subsequent processes only when all planned process activities are completed? Is there evidence of continuity between the various support processes? Do the interfaces between Business Units within, and across, Division Portfolios operate smoothly? Does information flow freely between support processes? Is there evidence of a reduction in process variation? Are participants adequately trained to carry out roles, responsibilities, and authorities involved in the process? Indicate any problems you uncovered with the processes: 4. Provide brief details on any areas that you found were well-implemented, particularly effective or worth noting as positive traits Page 6 of 6