Inputs are what the review looks at. Outputs are what it produces, and the outputs are what an inspector will judge the review by. A review with excellent inputs and no outputs has demonstrated that senior management saw the problems and did nothing. That is worse, in the inspector's eyes, than not looking.
What EU GMP and ICH Q10 require as outputs
ICH Q10 section 3.2.4 lists the outputs of the review of process performance and product quality: improvements to manufacturing processes and products; provision, training or realignment of resources; and capture and dissemination of knowledge. Section 4.3 lists the outcomes of the review of the quality system: improvements to the system and related processes; allocation or reallocation of resources and training; revisions to the quality policy and quality objectives; and documentation and timely communication of the results of the review and of the actions taken.
Put together, there are four categories of output that every review should be able to show: decisions about the system itself, decisions about resources, improvement actions, and changes to the quality policy and objectives. A review whose minutes contain none of the four has not produced an output, whatever else it contains.
Decisions about the system
The review is the one forum with the authority to conclude that the quality system is, or is not, suitable, adequate and effective. That conclusion should be stated in the minutes in those words, with the basis for it. 'The review concluded that the system remains effective, on the basis that all objectives set at the previous review were met, no critical findings were received and the deviation and complaint trends are within limits' is a defensible statement. So is 'the review concluded that the CAPA process is not effective, on the basis of a 41 per cent effectiveness check failure rate, and directed the following changes'. What is not defensible is a review that never reaches a conclusion about the system at all.
Decisions about resources
EU GMP 1.5 and 2.1 and ICH Q10 2.4 place the provision of adequate resources with senior management, and the review is where that responsibility is exercised. Every resource request in the input pack must receive a decision: approved, declined with reasons and a risk statement, or deferred to a named date with an interim measure. A deferred request with no interim measure is a declined request that has not been admitted.
Improvement actions that can be closed
Most review actions fail because they are written to end the discussion rather than to change anything. 'QA to look at training' cannot be closed because nothing is defined. An action that can be closed has five parts.
- A specific change: what will be different when the action is done.
- A named owner, a person and not a department, with the authority to make the change.
- A date, agreed by the owner in the meeting, not imposed afterwards.
- The resources attached, or a statement that none are needed.
- An effectiveness measure: what metric will show the action worked, and at which review it will be reported.
Actions from the review should live in the same action tracking system as CAPAs, or in a dedicated log with the same discipline: unique identifier, status, extensions with rationale and approval, and closure with evidence. An action closed on the owner's say-so, with no evidence attached, will be reopened by the inspector.
Changes to the quality policy and objectives
ICH Q10 2.2 expects the quality policy to be reviewed periodically for continuing effectiveness, and 2.3 expects quality objectives to be established, communicated and measured. The management review is where this happens. Each review should confirm or revise the policy, and should set objectives for the coming period that are measurable and that the next review will report against. Objectives that are never revised and never measured are a finding waiting to happen; so are objectives so vague ('improve quality culture') that nothing can show they were met.
Knowledge and communication
ICH Q10 3.2.4(c) and 4.3(d) add two outputs sites often forget: capture and dissemination of knowledge, and timely communication of the results. If the review concluded that labelling reconciliation on line 3 was the source of a third of the site's deviations, that knowledge should reach the line 3 team, the sister sites, and the next PQR for the products on line 3. Minute who will communicate what, to whom, by when.
Module 5 of the course works through a set of real review outputs, rewrites each to the five-part standard, and builds the objectives and policy review into the annual cycle so that the next review has something to measure.