5 Top Tips for Implementing Effective Quality Risk Management

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

Quality risk management (QRM) is an integral part of GMDP that strives to protect patients by applying a scientific and practical approach to decision-making for different aspects of pharmaceutical quality throughout the product lifecycle.

The ICH Q9 QRM Guideline is referenced in Chapter 1 of EU GMP and reproduced in Part III of the guide and is intended to provide guidance on the principles, and examples of tools for QRM that can be applied to different aspects of pharmaceutical quality.

Following the Revision 1 update of ICH Q9 which became effective in July 2023, EPiC have been providing bespoke training and supporting clients as they assess and update their own PQS procedures in line with the changes to make QRM activities more effective and value adding.

ICHQ9(R1) provides multiple examples of potential applications of QRM, and If you have not done so already, we recommend you review the training materials on the ICH Q9 webpage https://www.ich.org/page/quality-guidelines and follow our top tips for effective QRM:

1. QRM application – QRM can be applied anywhere there is potential risk across the business and across a product’s lifecycle. In applying QRM, it is important to ensure that patient safety and product quality considerations remain front and centre, as patients are putting trust in the decisions you make. QRM cannot be used to justify bad practice and non-compliance with GMP requirements.
2. Risk Review – Be proactive and develop mechanisms to prompt reviews of existing risk profiles and control measures as your knowledge and experience increases. For example, set aside time at Quality Management Review meetings to review risk registers, review risk assessments associated with specific manufacturing processes, perform a review of engineering activities to confirm that planned preventative maintenance is on track and equipment is performing as expected, periodically review supplier performance and changes to confirm existing risk ratings are appropriate.
3. Adopt a QA mindset – Design your processes to deliver a quality output rather than relying on problems/defects being detected at the end of the process. Provide training in the tools and techniques to the people involved in QRM activities and consider using experienced facilitators for more formal QRM processes.
4. Think about the people involved – subjectivity can directly impact the effectiveness of risk management activities and the decisions made, so it is important to be able to recognise and control subjectivity, bias, assumptions, and mental shortcuts. This can be achieved by ensuring that risk questions are clearly defined, appropriate QRM tools are applied, and by being objective and evidenced based when assessing data and proposed control measures.
5. Apply critical thinking – Critical thinking requires us to actively engage our brain to be able to work out complex problems. In working through the risk assessment, risk control and risk review phases of QRM, think clearly and rationally to understand the logical connection between ideas. Use the Q9 QRM toolkit to provide a systematic approach to identify, analyse, and solve problems rather than using intuition or instinct, but be prepared to question ideas and assumptions rather than accepting at face value e.g. is the tool fit for purpose, does the output seem right?

Effective and proactive QRM can enable better, more informed, and timely decisions throughout the product lifecycle, and we hope that our top tips will provide you with some useful ideas on how to further enhance your QRM processes.  

Get in touch if you want to know more about our bespoke QRM and critical thinking training.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com

Getting to the Root of the Problem – 5 Top Tips for Root Cause Analysis & Investigations

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

During my time as MHRA GMDP Inspectorate Operation Manager part of my role involved taking overall responsibility for planning and delivery of the annual MHRA GMP Symposium.

Year on year delegates would request an update on deficiency data and examples of the most cited deficiency topic areas. And year on year the most common deficiency references related to Pharmaceutical Quality System (PQS) and Documentation requirements.

This may not be surprising given that regardless of the size, complexity, and licence type of the site being inspected, all are expected to have a PQS and associated documentation, and at least some of the elements of the PQS will always be inspected.

Is it therefore, inevitable that all GMP inspections are destined to receive a PQS-related deficiency, or is it possible to buck the trend by getting to the root of the problem?

A closer look at the latest MHRA deficiency data from 2019 Good Manufacturing Practice Inspection Deficiencies – GOV.UK (www.gov.uk), and from EPiC’s own experiences of providing pre-inspection and remediation support, shows EU GMP Chapter 1 reference C1.4(xiv) relating to poor root cause investigations and ineffective CAPA as the most frequent recurring PQS deficiency.

Here are our top tips for improving root cause investigations to help you get to the root of the problem:

1. Understanding the meaning of Root Cause Analysis (RCA) – RCA is an activity intended to identify the origin or root cause of the problem. The root cause is the leading cause of the problem and may be made up of several factors. It’s essential to the identify root cause rather than just causal factors. Causal factors are contributing actions that affect an incident/event’s outcome. Removing a causal factor will be beneficial but on it’s own, won’t prevent the problem from recurring.
2. Use an appropriate level of RCA – The level of RCA undertaken should be commensurate with risk and be based on Quality Risk Management (QRM) principles. For a simple problem that presents no risk to product quality or patient safety for which there is an obvious root cause, then a simple correction to fix and document the issue can be justified without the need for RCA and additional CAPA. However more complex or recurring problems that present a potential risk to patient safety and have no obvious root cause will require in depth investigation using RCA tools and may generate multiple CAPAs.
3. Thorough documentation – RCA investigations should be thoroughly documented to demonstrate the risk-based rationale, tools, and critical evaluation of potential root causes and causal factors used to identify the root cause. The information could provide learnings for future investigations or for education and training such as examples for inclusion in GMP refresher training. Having the complete picture to hand will also help you explain in a clear and succinct way what the issues were and what is being done to improve the situation should you need to present RCA investigation data during an inspection.
4. It’s a team effort – RCA investigations should involve as many people as is reasonably practicable. Multidisciplinary teams contribute different knowledge, experience and points of view that are valuable to the investigation as they help to generate a wider range of potential root causes and causal factors and can enhance the application of critical thinking to form a judgement on the likely root cause. Sharing the issues and output from the investigation through team meetings, Quality forums, newsletters etc. can help others learn from the issue which may prevent similar issues elsewhere.      
5. PQS metric targets – Beware of setting targets e.g. 30 days to complete RCA investigations as this may drive the wrong behaviours. Although it makes sense to have a target to complete investigations as soon as possible, speed is not as important as identifying the true root cause. Meeting the target should not prevent a thorough investigation and investigations should not be stopped at an inappropriate level just to meet a target. The PQS should therefore acknowledge that complex investigations may take longer than the target and have a mechanism to document and maintain oversight.

By following these tips, you can turn the inevitable into avoidable by enhancing your RCA knowledge and investigation process, and reduce the likelihood of receiving a PQS deficiency for poor RCA investigations.

Get in touch if you want to know more about our bespoke root cause analysis and effective CAPA training.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com

Ensuring Excellence in GXP Compliance: Discover the EPiC Difference Through Our Client Testimonials

Our mission has always been to foster product quality, patient safety, and ensure the highest regulatory standards. But don’t just take our word for it—let our clients tell you about their EPiC journey. 

Check out our latest testimonials in this short video “What Our Clients Say” and see why EPiC Auditors is a trusted partner for pharmaceutical businesses seeking excellence in their GXP compliance needs.

WHAT DO YOU REQUIRE?

WE SPECIALISE in helping pharmaceutical and biotechnology companies, as well as other associated healthcare clients, to achieve and maintain regulatory compliance and excellent pharmaceutical quality systems, to best industry standards.

If you need our help and support, then please don’t hesitate to contact us; enquiries@epic-auditors.com

Call: +44 (0)1244 980544

Following on from the how to prepare for a regulatory inspection advice we shared during our recent virtual symposium, one of EPiC’s GMP consultants has recently returned from helping a client in California with their inspection readiness activities in preparation for the site’s first EU GMP regulatory inspection.

The on-site consultancy support provided the opportunity for the inspection hosts and subject matter experts (SMEs) to gain an appreciation of the EU GMP inspection process style and what to expect. It highlighted general points for all staff as well as some specific Do’s and Don’ts.

Newfound Confidence

The visit provided recommendations for the management of the inspection with respect to hosting, tour, and the ‘back room’ logistics and provided the opportunity to practice the inspection document request system. The facility tour focused on identifying key GMP issues so that the consultant could work with the SMEs to develop recommendations to address any issues and provided an opportunity for the SMEs to practice presenting information to an inspector.

The client reported that our consultant had been “an amazing asset by highlighting some gaps, conveyed the likely criticality of those gaps, and provided recommendations on how to address.” The inspection readiness support has given the site a newfound confidence to approach the inspection with a realistic yet positive mindset.

The client reported that “whilst we know we will have some observations, we now feel confident that the site will show well and will be able to demonstrate that we are in a state of control”, which all bodes well for a successful inspection outcome.

Are you Inspection Ready?

Take a look at our recent top-tip article by Michelle Yeomans focusing on Inspection Readiness to help you stay calm and be prepared!

Get in touch if you want to know more about our mock inspections or bespoke inspection readiness training by using our contact form here: Contact Us

“Keep Calm and Be Prepared” – Inspection Readiness Top Tips

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

Judging by the number of enquiries we are receiving to provide ex MHRA Inspectors to assist with inspection readiness preparations or remediation activities; it certainly looks like the number of regulatory inspections and supplier due diligence audits are returning to pre-pandemic levels.

Inspections are an opportunity to demonstrate compliance, so when you receive notification of a regulatory inspection (or external audit), keep calm, and use our top tips to help be prepared:

1. Inspection Scope  – Make sure that the purpose and scope of the inspection are clearly understood to help identify the relevant people, products, premises, systems, processes, and procedures that are likely to be involved so that these can all be factored into an inspection readiness plan. As part of the plan, consider the need for inspection awareness training for staff likely to be directly involved, especially if they have not previously experienced a regulatory inspection. Do not forget to check any contractual agreements, as contract acceptors may be required to notify the contract giver of any regulatory inspections.  

2. Compliance Status – Leverage output from the pharmaceutical quality system by referring to performance and trend data from self-inspections, deviations and CAPA, risk assessments, management review, etc. to understand how the quality system and operational processes are performing. This will either give you assurance that you are inspection ready or help identify specific compliance concerns or weakness to enable you to focus on implementing mitigating actions.  

3. Front and Back Room Organisation – Based on the scope and purpose of the inspection, identify and assign appropriate numbers of personnel (including deputies) to act as hosts, tour guides, scribes, runners, back-room staff handling document requests, and subject matter expects (SMEs). Provide some basic inspection preparation awareness training to give an overview of the inspection process and ensure everyone involved has a clearly defined role and purpose. 

4. Turning Negatives into Positives – In completing your inspection readiness plan you may have identified potential deficiencies or there may be questions you would not want an inspector to ask. Encourage the SME’s who know the areas of weakness to practice explaining in a clear and succinct way what the issues are and what is being done to improve the situation. Being able to clearly explain the issues, mitigating actions and CAPA already in place can help to reassure the inspector that a situation is under control and may avoid or reduce the severity of a deficiency.    

5. First Impressions Count – Get the inspection off to a positive start by anticipating likely questions and areas of interest and have documentation and premises ready for inspection.  Prepare a brief presentation covering site activities and confirm any significant changes since the previous inspection (if it is not the first inspection). Check that previous inspection actions have been closed and have evidence of closure to hand. Identify and walk the physical inspection routes and tidy the areas focusing on housekeeping and first impressions. Plan to walk the expected route each day to check on housekeeping, as new deliveries may have arrived, new production batches set up, new teams on shift, etc.   

By following these tips, you can prepare for an inspection by using practice runs and role-play scenarios to practice hosting, tracking, and responding to questions (including the difficult ones!) and help build confidence in being able to demonstrate compliance. 

Get in touch if you want to know more about our mock inspections or bespoke inspection readiness training.  

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com

 You may also like to read our Case Study 1: Inspection Readiness: https://epic-auditors.com/case-study-inspection-readiness/