How to implement a robust Quality Risk Management Program

Quality Risk Management has been an industry hot topic for the last number of years and the recent draft Annex 1 revision has highlighted the particular focus that regulators will place on this element of the Pharmaceutical Quality System in the future.

In the pharmaceutical industry, we are still accustomed to looking for black and white guidance on how to implement controls that impact the quality of our product. However, with the rising prominence and importance of Quality Risk Management we need to implement QRM programs that will give us the information and scientific rationale for how and when we implement controls in our processes.

QRM is not a new concept in the industry, but we are still finding our feet, often resulting in unwieldy and complex risk assessments, primarily based on FMEA that have become ‘tick the box’ exercises to satisfy the regulators. When this happens, we are missing an opportunity to significantly benefit from the correct implementation of a QRM program.

QRM programs when implemented successfully reduce the workload on an organisation by focusing effort on the areas of highest criticality which also brings a knock-on positive effect on product quality and patient safety. QRM implementation does not need to involve convoluted additional processes that are resource heavy but should focus at a base level on five questions;

  1. What can go wrong?
  2. How bad will the effect be if it goes wrong and who will be impacted?
  3. What controls do I have in place to prevent things going wrong and are they robust enough?
  4. Will I detect something going wrong?
  5. Do I need to improve my control to prevent issues from happening?

The focus in all cases should be on prevention of issues and pre-emptory solutions to potential problems in a process in order to safeguard product quality and patient safety.

QRM can also be used successfully to enhance knowledge management by providing complete overviews of processes or systems, their weaknesses and the critical controls that are in place to prevent issues from occurring.

Once implementation of QRM and application of its principles has started for all critical processes, the next task is ensuring that the program is correctly integrated and communicating with all other site systems, particularly the PQS.

An example of this integration is change control, a process with which QRM should be closely linked. Typically risk assessments are generated to assess the impact of a change control but this approach alone can be short sighted. When a Change Control is proposed, the change should also be assessed against all existing relevant risk assessments to determine if the change will reduce or increase the risks that have been identified in the process, facility or system.

Likewise, the distribution of capital funding should ensure that areas of higher risk are funded before areas that may not impact product quality to the same degree.

A successfully implemented and robust QRM program should provide the glue that holds it all together, providing channels of communication, methods for documenting valuable information, a template for making decisions and a mechanism for prioritisation that ensures that product quality and patient safety is at the heart of everything we do.

If you would like support in the implementation of a QRM program or an independent review of the QRM processes you have in place, PharmaLex have subject matter experts in this area that are happy to help.

To discuss how PharmaLex can support your organisation, please connect with us on +353 1 846 4742 or email us at


This blog is intended to communicate PharmaLex’s capabilities which are backed by the author’s expertise. However, PharmaLex US Corporation and its parent, Cencora, Inc., strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice. 

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