Starting from the end, let’s review some of the requirements in the new draft PIC/S guidance.
Prior to change closure
|Changes meet their intended objectives and pre-defined effectiveness criteria. Any deviations from those criteria are adequately assessed, accepted and managed/justified. Whenever possible, quantitative data are leveraged to objectively determine change effectiveness (e.g. statistical confidence and coverage).||Clearly delineating what effective means as a date is critical to generate data.|
CQV activities can tell you if the intended objective is met. Effectiveness reviews must be made up of:
Sufficient data points, as described in the implementation plan, gathered to a described timeline, before an assessment of the change is made.
The success criteria should be achieved. If not, reasons why they have not been achieved should be assessed along with the mitigation steps to address the reasons why, including reverting to the previous operating state where appropriate. This may require the proposal of a subsequent change or amendment of the implementation plan to ensure success.
Data and knowledge gathered from implementation of the change should be shared with the development function and other locations, as appropriate, to ensure that learning can be applied in products under development or to similar products manufactured at the same or other locations
|As part of the quality risk management activities, residual risks are assessed and managed to acceptable levels, and appropriate adaptations of procedures and controls are implemented.||These are action items in the change control. |
As part of the closure activities, revise the risk assessment, clearly delineating risk assessment in two phases.
|Any unintended consequences or risks introduced as a result of changes are evaluated, documented, accepted and handled adequately, and are subject to a pre-defined monitoring timeframe.||Leverage the deviation system.|
Prior to or after change closure
|Any post-implementation actions needed (including those for deviations from pre-defined acceptance criteria and/or CAPAs) are identified and adequately completed.||If you waterfall into a CAPA system, it is important to include effectiveness reviews that are to the change, and not just to the root cause.|
|Relevant risk assessments are updated post-effectiveness assessments. New product/process knowledge resulting from those risk assessments are captured in the appropriate Quality and Operations documents (e.g. SOPs, Reports, Product Control Strategy documents, etc.)||Risk management is not a once and done for change management.|
|Changes are monitored via ongoing monitoring systems to ensure maintenance of a state of control, and lessons learned are captured and shared/communicated.||Knowledge management is critical as part of the product management lifecycle.|
Lessons learned are critical.