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22.01.2025Scope / Area Risk Levels
H= "Large number of NC, can have a HIGH impact on product / system", MED = "low of NC or low impact on product / system" " and LOW= 'Low of NC or no impact on product / system"
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Colour Coding H= each IA, M= 2nd IA, and LOW - ONE (1) IA /per annumInsert new time hereCOMPLETED: Copy and paste (with Colour) and insert dateAUDIT not done reason recorded under commentsPLANNED: Copy and paste (with Colour) and insert dateAUDIT not done reason recorded under comments
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AUDITOR insert namePLANNED: Copy and paste (with Colour) and insert dateAUDIT not done reason recorded under commentsAUDIT not done reason recorded under commentsStage 1
Ibratsa
30 - 31st Jan 2023

Internal Audit
SCRudolph-Shortt
13th Sept 2022
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Date Schedule Q4 2026Q3 2026Q2 2026Q1 2026Q4 2025Q3 2025Q2 2025Q1 2025Q 4 2024 mid DecQ3 2024 mid Sept
Q 1 2024
JC AUDITORS March 2024
Q4 2023Q3 2023Jan 2023
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Audit activityRISK X X X XXXXXXXX
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QUALITY MANUALLX X X X X XXXX
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Quality PolicyL X X X XX X XXX
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Environmental Sustainabilty PolicyLX X X X X XXXX
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POPI PolicyL X X X XX X XXX
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Cybersecurity PolicyLX X X X X XXXX
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Pandemic or Occupational Biological Hazards PolicyL X X X XX X XXX
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Change Control SOP HXXXXXXXXXXXXXXX
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Training and Awareness_Competence HXXXXXXXXXXXXXXX
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Documentation (Procedures and Records Control)LX X X X X X XX
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MD File n/a x XX
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Internal & External CommunicationsLX X X X XXXXXXX
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Management ReviewHXXXXXXXXXXXXXXX
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Improvement ActionsHXXXXXXXXXXXXXXX
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Regulatory ControlM X X X XXXXXXXX
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Adverse Incident, Advisory Notices and RecallL X X X XXXXXXXX
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Clinical Evidence n/a
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PharmacoVigilance and Post Market Surveillance LX X X X X X XX
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Promotional and Training Material ApprovalL X X X XX X XXX
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Customer Focus, Feedback and ComplaintsMXXXXXXXXXXXXXXX
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External Providers (Purchasing / Supplier Management)HXXXXXXXXXXXXXXX
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Infrastructure & EnvironmentM X X X XX X XX
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Service Provision OperationLX X X X X XXXX
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Cleanliness (Facility & Personal Hygiene, Waste & Pest Control), Health & SafetyH XXXX XXXXXXX XXXX
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Sales, Customer Related Processes & ReturnsMX XXX XX XXXXXX
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ValidationL X X X XXXXXXXX
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Warehousing, Preservation, identification & TraceabilityHXXXXXXXXXXXXXXX
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Vehicle ManagementM X X X XX X XXX
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Stock ManagementMXXXXXXXXXXXXXXX
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Product DecontaminationHXXXXXXXXXXXXXXX
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Monitoring & Measurement of Products and ProcessesL X X X XX X XXX
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Data AnlaysisL X X XXXX
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Nonconformance - Corrective ActionHXXXXXXXXXXXXXXX
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Preventative Action Risk Assessment LXXXXXXXXX
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QMS AuditingHXXXXXXXXXXXXXXX
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SEpt 24
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Comment REPORT (done with the JCA CAPA) and other notes for IMPROVEMENTREPORT Jan 2025Planned for mod Dec but due to change of stff and pening holdays moved to 22 Jan 2024 Q2 ommitted due to Ibratsa / JC auditors CA and change of staff04.03.2024 pre transfer to JC auditors stage 1 7 March & stage 2 14&15 March 2024IBRATSA CAIBRATSA CAREPORTREPORT
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CORRECTIVE ACTION
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