.\u00a0 Here it might show a problem internally if large gaps were not identified until an internal audit.\u00a0 Are the operators not advising management?\u00a0 Is everyone trained? Are people paying lip service to the need to follow procedures etc?<\/em><\/li>\n<\/ul>\nWhat are the Regulatory Requirements?<\/strong><\/p>\n\n- In Australia, the TGA requires healthcare products be manufactured according to the PIC\/s Guide to GMP .\u00a0 Chapter 1 states that a Quality Assurance internal audit system needs to be in place.<\/li>\n<\/ul>\n
Scheduling the Internal Audit<\/strong><\/p>\n\n- At the top level, you should ensure your site has an internal audit schedule that examines processes across your site.\u00a0 Eg.\n
\n- Learning and Development<\/li>\n
- Quality Assurance<\/li>\n
- Reg<\/li>\n
- Quality Control<\/li>\n
- Logistics<\/li>\n
- Engineering<\/li>\n
- Validation<\/li>\n
- Production<\/li>\n
- Chemistry<\/li>\n
- Microbiology<\/li>\n
- Cleaning<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
Stick to the schedule!<\/p>\n
You could review every single process each year, though if you have a small team or auditors and a large facility, I\u2019d recommend setting up a schedule to cover the documentation update cycle and when the overriding SOP is due to be updated, audit the process 6 months before so any deficiencies identified can be incorporated into the documentation update. \u00a0\u00a0The added bonus here is that you are not expending time updating a document that \u201cwas just updated\u201d.\u00a0 Be sensible here as if every process was being updated in June, auditing everything in January would be ineffective.\u00a0 Aim for at least one process audit a month.\u00a0 Give consideration to areas identified as issues in regulator audits, or areas where there is high staff turnover.<\/p>\n
Planning the Internal Audit?<\/strong><\/p>\nWhy plan?\u00a0 To ensure your audits are consistent and effective.\u00a0 In reality, you\u2019ll be following documented internal procedures designed to ensure this.<\/p>\n
Without planning, you are wasting your time.\u00a0 With your next audit identified\u2026<\/p>\n
\n- Examine the documentation: SOPs, OIs, training records, etc.\u00a0 This enables you to formulate questions and identify key steps in the process.<\/li>\n
- Use an audit checklist.\u00a0 This might form part of your internal auditing SOP or OI.\u00a0 If you use your own, it forms part of the audit data.<\/li>\n
- Review the previous audit report for the process to determine what was an issue then in order to see if improvements have actually been made.<\/li>\n
- Schedule the audit with the relevant Area Manager to ensure resources are available.\u00a0 Each department should be issued the audit schedule when approved, so news of an impending audit is not a surprise.<\/li>\n
- Confirm the audit time and date a week out and the day before.<\/li>\n
- NOTE!\u00a0 If auditing an entire area, you\u2019ll need opening and closing meetings etc.\u00a0 For a single process, things are much simpler.<\/li>\n<\/ul>\n
Conducting the Internal Audit?<\/strong><\/p>\n\n- Advise the attendees that this is a fact finding operation designed to improve the process and smooth things come external audit time.\u00a0 You want to find deviations and have known deviations communicated to you.<\/li>\n
- Stick to the plan.\u00a0 That way you will be efficient.\u00a0 If a deviation is noticed, note it down.<\/li>\n
- Ask questions like\n
\n- \u201cShow me\u2026\u201d<\/li>\n
- \u201cHow do you\u2026\u201d<\/li>\n
- \u201cHave you\u2026\u201d<\/li>\n
- \u201cWhat happens when\/after\/next\u2026\u201d<\/li>\n
- \u201cWhy\u2026\u201d<\/li>\n<\/ul>\n<\/li>\n
- You want to get a feel for how well the operators understand the task(s) at hand.<\/li>\n
- You want to make sure the task is being done correctly.\u00a0 No additional or missing steps.<\/li>\n
- If you record a deviation, advise the auditee of this.\u00a0 Tell them this will improve the process and it is not a negative reflection on them (as it will and it is not!)<\/li>\n<\/ul>\n
Followup Activities?<\/strong><\/p>\n\n- With reference to your notes, write the report.\u00a0 I favour bullet points.<\/li>\n
- The report should include date(s), attendees, process audited, location, documentation reference (Policies, SOPs, OI\u2019s, possibly standards).<\/li>\n
- Good AND<\/em> bad points<\/li>\n
- What you have observed that might improve the process, along with logical justifications for such thought.<\/li>\n
- Where deviations are found, Corrective and Preventative Action (CAPA) needs to be formulated, scheduled and assigned in order to improve the process.<\/li>\n
- Sign off on the audit.\u00a0 Sign off on the CAPA. QMS manager (or equivalent) to sign off on the report.<\/li>\n<\/ul>\n
Did you find this informative or useful? Please consider a small donation so I can expand and improve on what I deliver.<\/strong><\/p>\n