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Mar 15, 2021 5 min

6.3.2 Preparing the audit activities

from Establishing an Auditing Programme/ Conducting and Audit Hosted by Marilla Keating

This podcast gives an overview of how you prepare for the audit a. Review of Documented Information( SOP, Spec, Manuals, flow charts and if possible reports such as previous audits, open CAPA’s, NCM, trends, changes in the area. These will inform an understanding of the processes, and help to access the extent of compliance and the degree of readiness, to assess current performance and identify possible areas of concern b. Audit Planning ( to create an audit plan based on doc review above and auditor expertise, area of concerns, complexity of the process c. Assigning audit team ( taking into account expertise, competency, availability) d. Prepare documented information for audit (checklist, sampling plans/details, paperwork (templates such as trails, report format, sampling sheet, process analysis sheet)

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