5 Top Tips to Maintain Perspective Critical to GMDP Compliance
Article By Lewis Corbett, EPiC Business Manager
Compliance challenges can result in product quality issues, supply shortages and threats of regulatory action, which in turn puts increased pressure on a business and individuals. The need to maintain supply whilst trying to implement remediation and compliance improvement activities often results in competing priorities, aggressive timelines, and backlogs in the closeout of deviations and CAPAs. It’s at times like these that it’s essential to be able to see the wood for the trees, so here are our top tips based on ICH Q9 risk management principles, to help you prioritise the various demands on your time and resources.
1. Understanding Risk – There will always be tasks that have to be completed to maintain a fully functioning and compliant Pharmaceutical Quality System (PQS) and additional actions may arise because of deviations, changes, self-inspections etc. There may not be enough resource to complete everything required in the ideal timeframe. As a result, some actions and tasks may have to wait. To be able to decide which actions and tasks to prioritise, it’s important to consider and understand the associated risk.
Risk is a combination of the severity of the potential harm, and the probability that the harm is realised. Therefore, the risks associated with not completing different actions and tasks will vary depending on their potential severity of harm and how likely the harm is to occur. For example, actions which if not completed will have a high probability of impacting patient safety would be considered a higher priority than a purely administrative task associated with maintaining the PQS where there is likely no immediate impact on patient safety.
2. Risk Ranking – Risk ranking tools can help to assign a priority to each action or task by questioning whether the severity of harm has an equal impact. A simple risk ranking tool can be applied by thinking about critical business areas such as patient safety, regulatory compliance, and product availability, and then assigning a priority to each action or task based on a simple ranking against a single business factor e.g. risk to patient safety of low, medium or high = low, medium or high priority.
In practice however, things rarely depend on one factor, but it is possible to use a multi factor risk ranking by assigning scores based on the impact to multiple business areas, with the total risk score being equal to the cumulative total e.g. potential impact on patient safety plus impact on regulatory compliance plus impact on product availability. Using the multi factor risk scoring the task or action with the highest total score is given the highest priority.
The ranking tools are flexible, and they can be adapted to enable the selection of different business areas, and for the scores applied to different business areas to be given a different weighting during ranking, based on their relative importance. What’s important is to define and document the relative importance of different areas and what each score means in your situation.
3. Risk Communication – Having identified the actions and tasks that need to be completed and assigned a priority to their completion, the rationale for the prioritisation needs to be documented for future reference and to enable the strategy to be agreed internally. Buy in from senior management is essential as they have overall responsibility for compliance with GMDP and are in a position to prioritise resource as required.
Plans and progress updates to address backlogs should also be communicated to staff as these can impact team morale. Communication of progress enables successes to be celebrated and for action to be taken to amend day to day work priorities if progress is not as expected.
4. Quick Wins and Working Smarter – Consider if there are any actions or tasks that are simple and could be done quickly? These may not be the highest priority from a risk perspective but if you can just get them done, they could have a positive effect on morale, help provide a sense of achievement and also improve metrics.
Avoid arranging separate update meetings by leveraging existing quality management or planning meetings to review progress and confirm priorities at a team, department or site level.
Leverage your technology to reduce the amount of time it takes to track progress and generate metrics for your review meetings, e.g. look to automate trackers where possible and combine remediation progress into existing trackers.
5. Prevention is Better than Cure – Finding issues before they cause a problem is more effective than fixing things when they go wrong. Ensure you have a robust self-inspection program, covering essential areas of your business and PQS, and that they are performed on schedule, and are taken seriously. Self-inspections provide an opportunity to identify concerns before they cause an issue.
Similarly identifying important operations within your business and proactively conducting risk assessments is a great way to improve process and business knowledge. For example, using Failure Modes, Effects and Criticality Analysis (FMECA) to consider what could go wrong at each step of a process and putting actions in place to mitigate risks as required.
Hopefully our top tips will help you appreciate that although there will always be tasks and actions that must be completed, not all tasks and actions are of equal importance. Prioritising based on risk will help you to maintain perspective and focus on the tasks and actions that are critical to your business such as patient safety and GMDP compliance.
Get in touch if you what to know more about how we can help you see the wood for the trees by providing advice and bespoke training courses on effective and value adding self-inspections and the practical application of ICH Q9 methodology to further enhance your Quality Risk Management (QRM) processes.
Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com