A management review is only as good as what goes into it. A review that has never seen supplier performance cannot decide anything about suppliers. A review that sees a count of complaints but not the trend by product and failure mode cannot decide anything about complaints either. The input pack is where most reviews are won or lost, and it is also the part an inspector can check against a list.
The lists you are checked against
ICH Q10 splits the inputs between two reviews. Section 3.2.4 asks for results of regulatory inspections, audits and other assessments, and commitments made to regulatory authorities; periodic quality reviews including complaints, recalls, process performance and product quality monitoring, and the effectiveness of changes including those from CAPA; and follow-up from previous reviews. Section 4.1 asks for measurement of achievement of the quality system's objectives and assessment of performance indicators: complaint, deviation, CAPA and change management processes, feedback on outsourced activities, self-assessment including risk assessments, trending and audits, and external assessments such as inspections and customer audits. Section 4.2 adds internal and external factors: emerging regulations and guidance, innovations, changes in the business, and changes in product ownership.
What each input must actually show
A list of headings is not enough. The review needs each input in a form that supports a decision. The pattern that works is the same for every input: the number, the trend, the comparison with a target or limit, the reasons behind the trend, and the question the review is being asked to decide.
- Deviations: count by classification, trend over at least eight quarters, breakdown by area and by cause category, repeat events, overdue investigations and the ageing profile. The question is usually whether the cause categories are being addressed, not whether the count is up or down.
- CAPA: open, overdue and extended actions, effectiveness checks passed and failed, and the proportion of CAPAs that are 'retrain'. A CAPA system with a 95 per cent on-time closure rate and a 40 per cent effectiveness failure rate has a problem the count hides.
- Complaints and feedback: rate per units sold or batches released, by product and failure mode, confirmed versus unconfirmed, time to acknowledge and close, and any reportable event.
- Recalls, product defects and regulatory notifications: every one, with root cause and status of commitments.
- Audits and inspections: findings from regulatory inspections, corporate and internal audits, customer audits and self-inspections under EU GMP Chapter 9, by classification and status, plus commitments made to authorities and whether they have been met.
- Supplier and outsourced activity performance: ICH Q10 2.7 and EU GMP Chapter 7 expect the quality unit to monitor suppliers and contract acceptors. Show rejections, supplier deviations, audit status, overdue quality agreements and any supplier on a watch list.
- Product quality review outputs: EU GMP 1.10, and ICH Q7 2.5 for active substances, require a periodic review per product, and 1.11 requires the results to be evaluated and the actions managed. The management review does not repeat them. It receives their conclusions: which products have adverse trends, which need revalidation, which PQR actions are open.
- Change control: volume, changes closed without effectiveness assessment, changes with regulatory impact and their variation status, and changes overdue for closure.
- Validation and qualification status: the validation master plan against the calendar, overdue periodic reviews, equipment and systems in a state that has lapsed, and the status of the continued process verification programme.
- Training: overdue training by department, effectiveness where measured, and any role filled by someone not yet qualified for it.
- Quality objectives and metrics: each objective set at the last review, the metric that measures it, and whether it was met. See the guide on metrics for how to present them.
- Resources: headcount against plan in QA, QC and production, vacancy duration, overtime, backlog in QC release and document review. This is the input most reviews omit and the one ICH Q10 2.4 and EU GMP 2.1 most clearly expect.
- Previous actions: every action from the last review, its owner, its status and, where closed, the evidence it worked.
- External factors: new regulations and guidance, pending inspections, changes to the business that affect the system, and changes in product ownership.
Who compiles it, and when
The quality unit usually assembles the pack, but the inputs belong to their owners. Production should present the deviation trend for production. Engineering should present the validation status. The supply chain function should present supplier performance. When QA presents everything, the review becomes a QA report and the other functions become an audience. When the owners present, the decisions are already half made.
Send the pack at least a week before the review. A pack tabled on the day cannot be read, and a review that reads slides aloud cannot debate. The pack itself is a record: it is the evidence of what senior management was shown.
The inputs inspectors look for first
Two inputs are missing more often than any other. The first is the status of previous actions, because it is the one that proves the review has consequences. The second is resources, because it is the one that embarrasses. A pack that shows QC release backlog rising for three quarters, with no decision on headcount, tells an inspector that senior management saw the problem and chose not to act. A pack that does not show the backlog at all tells them senior management did not look.
Module 2 of the course builds the input register from the EU GMP and ICH Q10 lists and works through a real pack, input by input, marking what is missing and what would need to be added for the review to decide anything.