Improving Compliance - Using quality management tool to reduce recurring issues

Happy New Year everyone!

As we embark on 2025, let's acknoweldge that while the calendar has changed, many challenges in the pharmaceutical and biotech industry haven't - namely non-compliances and manufacturing related issues. Deviations, CAPAs, incident reports will continue to be raised and actions implemented to address these. However, its not th eoccurrence of these issues that is problematic; it's when they become recurring or systemic that regulators begin to take notice.

Recurring and systemic non-compliances can have several undesirable impacts, e.g.:

1. Warning letters from regulator
2. Suspension or loss of licences
3. Loss of clients
4. Employee frustration & resignations
5. Increased cost of manufacturing & decreased productivity

To tackle these challenges effectively in 2025, we need to rethink our approach to managing non-compliances. In this month's newsletter, I'll explore three root causes and three quality management tools that can help address these root causes.

Root cause 1 - Lack of awareness of recurring and systemic non-compliances within the organisation.

In many regulated organisations, discussions around deviations & non-compliances are centred around numbers (how many deviations do we have? how many audit observations did we get? which department has most non-compliances? etc.). Senior management often do not focus on systemic non-compliances and deviations. Viewing and assessing regulatory issues in siloes (of departments, numbers, open/closed) masks the true root causes of these problems and we end up treating the symptoms, not the root cause. And the problem recurs.

Management Tool 1 - Revamp your Quality Management Review (QMR) agenda

This year scrutinise the QMR agenda of your organisation. Discuss and assess if the agenda truly represents your organisation's current operations, processes and challenges. Pay special attention to how audit observations (external as well as internal) and deviations are discussed as a senior management team. Instead of looking at trends in terms of open/closed and overdue observations or department wise breakdown, start classifying the non-compliances into other categories e.g. FDA's six systems, number of recurrences across the organisation, types of root causes etc.

By reviewing current non-compliances through an organisation-wide lens, you will be able to identify a common/systemic root cause and be able to implement the most effective mitigation actions.

Reason 2 - Not leveraging the internal audit process for continuous improvement.

Self inspections and internal audits are an integral part of a pharmaceutical quality system. Every organisation implements a procedure, an annual plan and designates a couple of individuals to execute the plan. However, most companies view this as an exercise in compliance with zero value addition to the business. Findings from these audits are relegated to audit reports and rarely reviewed in detail by functional managers or senior management team. Hence, opportunities to proactively indentify trends and recurring observations, is missed.

Quality Management Tool 2 - Customise your internal audit program

As you create your annual internal audit plan for 2025, review past company deviations, regulatory audit observations as well as industry observation trends. Identify recurring problems, areas of concern, systemic failures (e.g. recurring failure to follow procedures or repeated breakdown of equipment etc.). Create a schedule based on these reviews. For e.g. if one of the recurring audit observation from customer audits has been data integrity, then include data integrity as a stand alone audit item (across every function) in your annual audit calendar.

By changing the way you approach the internal audit process, you can proactively identify the areas of improvement and concern that are unique to your organisation and focus your resources on addressing these.

Reason 3 - Poor and ineffective communication of non-compliances

Audit non-compliances and deviations are a common occurrence in the pharmaceutical and biotech industry. Keeping staff continually updated on the various findings, recurrences and actions implemented, all the while managing routine production and quality operations can be challenging. Its not common to find staff not aware of similar or repeat observations made by two different clients or two different regulatory auditors etc. And this gap in timely communication is another reason for non-compliances to persist. Observations found in one department, may also apply to another area of the business. If these are not shared in a timely manner, the same observation will potentially occur in another area of the business at a different time.

Quality Management Tool 3 - Tailored Training content for effective communication

Training content within the regulated industry must be dynamic. It needs to be reviewed every year for adequacy and relevance. Often times, companies use off the shelf or old training content to deliver training. Company specific deviations, audit observations, annual regulatory trends etc. are rarely part of the training content or the annual training calendar. By tailoring training topics and content based on the review of your organisation's trends (management reviews and internal audits contribute the data for this), you not only make training relevant but also communicate the issues consistently across the organisation. Training followed by brainstorming helps identify the correct and most effective corrective actions for recurring problems.

As we step into the new year, let's change the way we we deal with non-compliance. I leave you with this famous quote from Albert Einstein

" We cannot solve our problems with the same level of thinking that created them."

I help organisations reduce regulatory non-compliances and improve productivity through customisation and simplification of their QMS programs. If you want to know more or are looking to address a specific quality management issue, pls reach out.

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