Top Tips for Implementing Effective Knowledge Management Practices

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

At the EPiC Autumn Compliance Seminar, I delivered a presentation outlining the direction of travel in demonstrating compliance  (Session 1. GMP Seminar 10th November 2022 9am to 10am) which highlighted how global regulators are looking at new ways to be agile and make best use of resources and reduce regulatory complexity.  

The aim is to benefit patients by supporting access to quality medicines by adopting the same requirements for the formats and data expectations in regulatory submissions and applying the same standards in regulatory review, assessment, and inspection to support reliance. Such approaches will require companies to demonstrate effective use of data, knowledge management and to implement a culture of continuous improvement throughout the product lifecycle.

How organisations create, manage, and use knowledge is a key component of an effective Pharmaceutical Quality System (PQS) as defined by ICH Q10. The need to minimise knowledge loss is a primary concern, as loss of knowledge can lead to poor risk-based decision making and inefficiencies in trying to retrieve past knowledge or having to  “reinvent the wheel” to replace lost knowledge.

Hardly a week goes by without seeing a post on LinkedIn from a network connection who is “happy to share” that they are starting a new position. Whilst this is exciting for the individual to be embarking on a new chapter in their career, what can organisations do to minimise the risk of specialist knowledge walking out of the door with them?

Tips for implementing effective knowledge management practices:

1. It’s important to recognise that it is the people and not the data that underpin an organisations’ knowledge base. Compile and maintain a list or matrix of subject matter experts (SMEs) to increase awareness of “go to” people and encourage communication, networking and sharing of past and current knowledge.
2. Don’t wait until someone is working their notice to try to capture all that they know, as there won’t be enough time to transfer valuable knowledge to colleagues. Think about how you can capture and manage knowledge as a continuous improvement activity e.g., capturing and implementing lessons learned and after-action reviews.
3. Advances in technology to support remote collaborative working accelerated during the Covid-19 pandemic and has increased the availability and accessibility of creative tools to capture and share information. Explore what options are available with IT and Data Management colleagues to make use of available tools to help build and improve your knowledge management systems.
4. Asking someone to write down everything they know about a particular product, process, system, operation is a daunting task. People may not be aware of the knowledge they possess or how valuable it is to others. Indecision on what to include could result in a lot of the implicit knowledge remaining in people’s heads and at risk of being lost. As implicit knowledge is often difficult to articulate, transfer of knowledge can be achieved more effectively by encouraging regular interaction with colleagues e.g., networking forums, and sharing practical experiences through coaching and mentoring opportunities.  
5. For knowledge to be usable, it needs to be captured in an effective manner. Consider using a variety of formats to encourage information sharing and capturing knowledge e.g., video recordings, voice notes, whiteboards, story boards etc. Look at how the resulting output could be adopted into workflows, SOPs, Work Instructions, etc. as continuous improvement helping to retain current knowledge and support the development of new knowledge.

The above practical tips are intended to help minimise the risk of knowledge loss and support compliance with the EU GMP requirement to implement quality improvements appropriate to the current level of process and products knowledge (EU GMP Chapter 1, 1.4 (xi)) and ICH Q10 principles.

If you need our help and support, then please don’t hesitate to contact us.

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

5 Top Tips for Calibration Success

Article By Darren Jones, Director & Senior Consultant for EPiC Auditors

Calibration is an often-overlooked area of the PQS; many calibration certificates are incorrect or don’t contain adequate detail and in many cases are not understood by the site experts!

Calibration services are frequently outsourced and I often find that key GMP decisions have also been inappropriately outsourced as well! Does the calibration company set the limits? Who determines how and when out of specification results are reported?

Many certificates do not state Pass or Fail… Why not? The certificates often just contain the limits and the data. I regularly find calibration results that do not comply with the limits- the calculations have not been done and no one in the Pharma company has checked the data!

Limits are sometimes specified as +/-2% of FSD (full scale deflection). What does this mean? Often the method of calculating this is not clear and the calculations used to determine this limit are not recorded or checked.

Given accurate instrumentation is key to achieving process control, which ultimately assures product quality, calibration requirements need to be understood and properly managed.

Tips for success:

1. Use multi-point calibration over the working range of the instrument.
2. Ensure you set, or at least approve the limits applied during calibration, don’t leave this just to the contractor.
3. Have a contract with the provider that includes instruments, frequency, limits, ranges and out of specification results reporting. Appendices containing tables can be useful to manage the detailed information.
4. Ensure results are reported as found and as left, i.e. pre and post any adjustment, you don’t want to miss a failed as found result.
5. Ensure limits are clearly understood. The SOP should show how to calculate limits e.g. based on FSD and these calculations should be documented and checked as per any other important calculation.  Evaluate the limits using Pass/Fail criteria.

If you need our help and support then please don’t hesitate to contact us.

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