PODCAST · education
Establishing an Auditing Programme/ Conducting and Audit
by Marilla Keating
6.2.0 Welcome/orientationSeries 16.2.1 Establish Audit Programme objectives6.2.2 Roles/responsibilities, competence of the person managing the audit programme6.2.3 Establishing the extent of the audit programme6.2.4 Identifying and evaluating audit programme risks6.2.5 Establishing procedures for the audit programme6.2.6 Identifying resources including auditors6.2.7 Set up review/monitoring activitiesSeries 26.3.1 Initiating audit6.3.2 Preparing audit activities6.3.3 Conducting the audit activities6.3.4 Preparing and distributing report6.3.4 Conducting the audit6.3.5 Follow up
Episodes
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Welcome and orientation to the Auditing Podcast series
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...
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6.2.1 Programme- Establishing Audit Objectives
In this podcast, I will outline what type of objectives you might have when considering first party (internal) audits, and second party (supplier) audits
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6.2.2 Roles, responsibilities, competency of the person managing the audit programme
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)…
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6.2.3 Establishing the extent of your Audit programme
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…
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6.2.4 Identifying and evaluating audit programme risks (and opportunities)
•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…
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6.2.5 Establish procedures and processes for the Audit Programme
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.
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6.2.6 Identifying resources for Audit Programme
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…
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6.2.7 Set up reviewing/monitoring activities of the Audit Programme
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...
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Introduction to Series 2- Conducting an audit
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
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6.3.1 Initiating the Audit
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,...
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6.3.2 Preparing the audit activities
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...
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6.3.3. Conducting audit activities
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
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6.3.4 Preparing and distributing audit report
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
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6.3.5 Completing the Audit
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
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6.3.6 Audit Follow up
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...
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ABOUT THIS SHOW
6.2.0 Welcome/orientationSeries 16.2.1 Establish Audit Programme objectives6.2.2 Roles/responsibilities, competence of the person managing the audit programme6.2.3 Establishing the extent of the audit programme6.2.4 Identifying and evaluating audit programme risks6.2.5 Establishing procedures for the audit programme6.2.6 Identifying resources including auditors6.2.7 Set up review/monitoring activitiesSeries 26.3.1 Initiating audit6.3.2 Preparing audit activities6.3.3 Conducting the audit activities6.3.4 Preparing and distributing report6.3.4 Conducting the audit6.3.5 Follow up
HOSTED BY
Marilla Keating
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Establishing an Auditing Programme/ Conducting and Audit currently has 15 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
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6.2.0 Welcome/orientationSeries 16.2.1 Establish Audit Programme objectives6.2.2 Roles/responsibilities, competence of the person managing the audit programme6.2.3 Establishing the extent of the audit programme6.2.4 Identifying and evaluating audit programme risks6.2.5 Establishing procedures for...
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Establishing an Auditing Programme/ Conducting and Audit has 15 episodes. Check the episode list to see recent publication dates and frequency.
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Establishing an Auditing Programme/ Conducting and Audit is created and hosted by Marilla Keating.
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