The templates the course is built on
Structure and guidance for every section, free. The sections that carry the most weight in an inspection show their heading and a summary here; the full guidance, the worked examples and the editable files are in the course.
Management review agenda and input pack
The agenda that forces a decision on every input, and the pack behind it: one section per input ICH Q10 3.2.4 and 4.1 and EU GMP 1.6 expect, each ending in a question the review must answer.
1. Review identification and attendance
Review number, date, period covered, site and scope. Required attendees by role (site head, head of quality, functional heads) and who actually attended. A delegate is recorded as a delegate, not as the role.
2. Status of actions from previous reviews
Every open action from the last review and any interim review: owner, due date, status, evidence of closure. Overdue actions are the first item on the agenda, not the last.
- Which actions from the last review are still open, and why?
- For closed actions, what evidence shows the action worked?
3. Deviations, nonconformances and CAPA
Full version in the courseCounts by class and by cause, repeats of the same failure mode, overdue investigations and CAPAs, and CAPA effectiveness results. Ends with the question the review must decide.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
4. Complaints, recalls and post-market feedback
Full version in the courseComplaint rate against units distributed, by product and category, confirmed versus unconfirmed, serious events and recalls, and any regulatory reporting made in the period.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
5. Audits, inspections and regulatory changes
Internal audit programme status, findings by area, external inspection outcomes and commitments, and new or changed regulatory requirements that affect the system.
6. Supplier and contractor performance
Approved supplier status, supplier-related deviations and complaints, audit findings, and any supplier on notice. The question is whether the approved list is still justified.
- Which suppliers caused a deviation, complaint or delay this period?
- Which supplier audits are overdue?
7. Product quality review, change control and validation
Full version in the coursePQR conclusions and open actions under 1.11, changes raised and closed, changes implemented without effectiveness review, and validation and qualification status including overdue requalification.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
8. Quality metrics and trends
Full version in the courseThe site's chosen indicators against targets and limits, presented with the trend rule that was breached or not, and the decision each breach requires.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
9. Resources, training and quality objectives
Headcount against plan, training compliance, overdue training by area, quality objectives against target, and resource requests the review must approve or reject.
10. Decisions required of this review
A single list, compiled from the question at the end of each input, of every decision the review is being asked to make. The chair works through it in the meeting.
- Which inputs have a question with no proposed decision?
- Which decisions need a resource commitment only senior management can make?
Action and decision register
The single record of every decision and action from every management review, structured so that the next review starts from it and an inspector can follow any action from the input that raised it to the evidence that it worked.
Decision log
Each decision with its number, the review it was made at, the input and question that raised it, the decision in one sentence, who made it, and the rationale. Rejected proposals are recorded too.
- Which input and which question does this decision answer?
- Was any resource committed, and by whom?
Action register
Full version in the courseEach action linked to a decision, with an owner by name, a due date, the deliverable, and status. 'QA to look at training' is not an action; 'QA manager to present root cause of overdue training in area B with a corrective plan by 30 June' is.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Effectiveness check
Full version in the courseFor each closed action: what was measured, over what period, against what criterion, and the result. Set before the action is closed, reviewed at a later review.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Escalations between reviews
Events that could not wait for the next review (critical finding, recall, failing supplier), who was told, when, and what was decided outside the cycle. Cross-referenced to the interim review record.
Overdue and carried-forward items
Actions past due date with the reason, the revised date and who approved the extension. An action carried forward twice is escalated to the site head at the next review.
Management review minutes
Minutes that show what was assessed, what was concluded and why, in enough detail that a reader who was not there, including an inspector two years later, can see senior management judged the system and acted.
Header, attendance and quorum
Review number, date, period, chair, minute taker, attendees by name and role, apologies, delegates. State whether the required roles were present and, if not, how the review remained valid.
Previous actions reviewed
Each previous action with its status as confirmed in the meeting, referenced to the action register. Overdue actions with the reason and the chair's decision.
Input by input: presented, discussed, concluded
Full version in the courseFor each input on the agenda: what was presented (referenced to the pack), the question raised, the debate in summary including disagreement, and the conclusion. 'Noted' is not a conclusion.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Assessment of the quality system
Full version in the courseThe review's overall judgement, in senior management's words, of whether the system is suitable, adequate and effective, with the evidence relied on and any areas judged not effective.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Decisions, actions and resources
Full version in the courseThe outputs ICH Q10 3.2.4 and 4.3 require: improvement actions, resource decisions, changes to the quality policy or objectives, each with owner and date, numbered into the register.
The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.
Approval and distribution
Signed by the chair and the head of quality with dates. Distribution list. Reference to the pack and the register as controlled records with retention period.
- Does the signature date make sense against the meeting date?
- Are the pack, the minutes and the register filed together?
9 sections are summarised above. The course opens all of them.
When the course opens you get the three templates as editable files, every section with full guidance and worked examples, three complete practice reviews, the assessment and the certificate. 2 to 3 hours, self-paced.