Establishing an Auditing Programme/ Conducting and Audit

This one minute orientation podcast is to introduce the concept of the podcasts and for me to practice! In this first series we will have a podcast on each of the seven considerations when setting up an audit programme listed below 6.2.1 Establish Audit Programme objectives 6.2.2 Roles and responsibilities, competence of the person managing the audit programme 6.2.3 Establishing the extent of the audit programme 6.2.4 Identifying and evaluating audit programme risks 6.2.5 Establishing procedures for the audit programme 6.2.6 Identifying resources including auditors 6.2.7 Set up review/monitoring activities for the audit programme The second series addresses the details involved in conducting one audit 6.3.1 Initiating the audit 6.3.2 Preparing audit activities 6.3.3 Conducting audit activities 6.3.4 Preparing and distributing   report 6.3.5 Completing the audit 6.3.6 Conducting audit follow up

In this podcast, I will outline what type of objectives you might have when considering first party (internal) audits, and second party (supplier) audits

Podcast looks at who is running the audit programme? •Their role is to establish audit programme, extent, scope, procedures, schedule, risks, responsibilities, resources, records, implement, monitoring and review •They must be competent to manage the audit programme ( knowledge / skills), including auditing practices, knowledge of audit criteria and other requirements ( legal?), knowledge of management quality system / process / product / customer if applicable

This podcast looks at the extent of your audit programme.... Think of it as setting up your audit schedule and all that you would consider such as the Who, When, Where, What, How of the programme Example of considerations- what areas will you audit, how often, when, who audits….. how often will you audit, what are the considerations/limitations?…… depends on risk, type of process, size, functionality, complexity, maturity, access, competency, any issues, any concerns, recent changes to the area, and internal and external influences,  Question: What factors will influence the extent of your audit programme?

•What are the risks associated with NOT meeting the audit programme objectives? What can go wrong with this programme –ie what could prevent it from achieving its objectives? Example of considerations: Have you sufficient resources, time, planning, access, covid, external factors, scheduling, audit team?

Your company will establish procedures/processes to ensure audits meet programme objectives. •Example of considerations:  audit procedure, templates for plans, checklists, reports, schedules. Have you defined the stages of auditing, follow up, reporting, records, are monitoring activities clear.

Besides good auditors, what else do we need to have in order to meet our audit programme objectives? Methods- audit method per procedure 2.Materials- Information/communication technologies if required 3.Machinery- Tools if required ( sampling, laptop, test equipment…) 4.Manpower – such as auditors, technical expertise How do you know auditors are competent? 5.Money and Time (travel time)

Procedures to•Monitor•Evaluate•Review•Improve •Review reports/records/outcomes/trends of individual audits and their associated CAPA’s •Evaluate conformity of all audits with audit programme, schedules, objectives •Evaluate performance of auditors –ability of team to implement the plans •Gather feedback from auditors / auditees •Review changes to standards, organisations, audit programme, audit methods, access to areas,

This second series will outline the six stages of the Audit lifecycle including 6.3.1 Initiating the audit 6.3.2 Preparing audit activities 6.3.3 Conducting audit activities 6.3.4 Preparing and distributing   report 6.3.5 Completing the audit 6.3.6 Conducting audit follow up

Initiating the audit is all about establishing initial contact with the auditee to Verify objective, scope, criteria of the audit Determining the feasibility of the audit re access to documents/premises, timing, resources. This allows an opportunity to confirm logistics such as access, shifts, outsourced processes, PPE requirements and to check any arrangement for confidential information and to outline any area of particular concern that the auditor would like to address (eg follow on audit)

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)

This podcast takes a closer look at the actual audit. This podcast has four parts, a)Opening Meeting b)Auditing- Look, listen, observe c)Generate Audit Findings- Evaluate evidence and document non conformities. Determine Audit conclusion d)Closing Meeting

Audit Reports should be complete, accurate, concise, clear and distributed within agreed time for sign off/dated to demonstrate commitment to address findings. Reports contain scope, criteria, names, dates, the audit findings/nonconformities and the overall audit conclusion

This podcast wonders if you need to return or dispose of the auditees documented information returned or disposed. What about reflecting on your audit and your team and conduct a lessons learned if part of your audit programme- to identify risks and opportunities for the audit programme

An audit cannot be closed out until the effectiveness of corrective action on the non conformities are verified. This can be done via email or at subsequent autdit of part of corrective action system…… This follow up is fed into audit frequency/scheduling and/or may inform the risk of the process/area.