ICH Q10 states , “Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system.” One of the central roles of the Quality reviewer/approver is to provide leadership, driving each event/record/etc, and the system as a whole, to continually improve. Quality does this in three ways:
- Ensuring the process is followed
- Validating the decisions made
- Creating a good history
Ensuring the process is followed
The quality review provides a coaching/mentoring opportunity to build and/or enhance capabilities and behaviors and recognize and reinforce desired behaviors.
Questions to Ask
1. What is the process? What process and steps apply?
2. What is expected? Look for: Standard work, expected state, variation to the expected state
3. What is working well? Look for: process being followed, ideas being generated, lessons shared
4. What is not being followed? Look for: variation to procedural requirements, poor technical writing
Validating the decisions made
Quality is ultimately responsible for the decisions made. For each decision we do the following:
- Identify alternatives. Once you have a clear understanding of the record from ensuring the process was followed, it’s time to identify the various options for each decision.
- Weigh the evidence. In this step, you’ll need to “evaluate for feasibility, acceptability and desirability” to know which alternative is best. It may be helpful to seek out a trusted second opinion to gain a new perspective on the issue at hand.
- Choose among alternatives. When it’s time to make your decision, be sure that you understand the risks involved with your chosen route. You may also choose a combination of alternatives now that you fully grasp all relevant information and potential risks.
- Take action. Ensure the quality system/process reflects the action.
- Review your decision. An often-overlooked but important step in the decision making process is evaluating your decision for effectiveness. Ask yourself what you did well and what can be improved next time.
Creating a good history
If it Isn’t Written Down, then it Didn’t Happen” is a guiding principle of the quality profession.
There are four major types of writing in quality: instructional, informational, persuasive and transactional. A well written event is both instructional and transactional.
Our quality systems record what happened, finalize recommendations and action plans, and to act as an archive. A well written report allows the reader to easily grasp the content and, if applicable, make informed decision. Report writing is a cornerstone of an Event/CAPA system (from incident identification to root cause through CAPA completion and effectiveness review), validation, risk management and so much more.
In short, reports are our stories, they form the narrative. And how we tell that narrative determines how we think of an issue, and how we will continue to think of it in the future.
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