Applying the “Risk-based Approach to the Quality Review

Although the concept of “Risk Based Approach” is not new to Validation, it is not often applied to the Quality Review for a Validation project. With the realities of increased volume of validation work and finite QA resources, it makes sense to target the Quality Review on the areas of most significance. I’ve mocked up this frame work to do exactly that. Any thoughts?


Targeted, Risk-based CSV Operational Quality (QA) Review

Request for Quality Review: The Validation Team (Business/Technical/Validation unit provides the list of deliverables to be generated for a given project in conjunction with the request for Quality Unit Review for the project.

The Quality Impact Assessment is conducted independently by the Quality Unit to determine the level of review required for a given Validation project. The Quality Unit will review and sign the Risk Assessment.

There will be an Internal Escalation Process to the QA review triggered by various flags or issues (e.g., request from stakeholders, problems detected during review, etc.) that can potentially increase the level of Quality Review within a project.

Quality Impact Assessment Targeted QA Review QA Approvals Example Scenario
Critical All deliverables; 100% Review Risk Assessment, Plan, Report Directed; GMP LIMS for Release
High Risk Assessment, Plan, User Requirements, Report, Sampling of Scripts (e.g., SQ N+1) Risk Assessment, Plan, Report PVDB; Clinical DB; Primary GLP Data System (e.g., SDMS)
Medium Risk Assessment, Plan, Report Risk Assessment, Plan, Report Clinical Trial Management System (Monitoring), Laboratory Data Generating System
Low Risk Assessment Risk Assessment Indirect GxP System (e.g., Learning Management System)


sqaThe Society of Quality Assurance is a great professional society for those of us working in Quality Assurance, etc. in Pharma and related industries. I just received email notification that the Quality Assurance Journal from April is now online……This is the one that contained all the abstracts from the annual meeting. A bit slow to move from print to electronic, but I suppose better late than never:

Quality Assurance Journal Volume 12, Issue 2 Content Alert
Dear SQA Colleague:

The Quality Assurance Journal, Volume 12, Issue 2 is now available online! To access the content, please log into the SQA members-only website at and visit the My Membership page from the menu at the top. The link to the Journal is available on the right side of the page under Publications. SQA Members do not need a separate login to access the Journal through the SQA website. The content listing for this issue is available below. All paid members of SQA receive an online subscription to the QA Journal, included with membership in SQA. If you are interested in contributing to the Journal, please review the information regarding submissions available on the SQA website.

We hope you find this information useful.


Elliott Graham, RQAP-GLP, Executive Director

Allison Travis, Program Director

Society of Quality Assurance
154 Hansen Rd, Suite 201, Charlottesville, VA 22911 USA
Phone – +1.434.297.4772 Fax – +1.434.977.1856
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Additionally, I would encourage any Quality professional (in the Pharma or related space) who does not yet belong to SQA to consider joining. You can learn a lot and remind yourself of things you already know.

Oh, I nearly forgot. There is also an SQA group on LinkedIn. I encourge you to join that as well.


SQA Thoughts after Catching Up on some Work

They say that no good goes unpunished….That goes doubly for attending a week-long off-site conference/training. I’ve been back from SQA for over two weeks now and am just getting to a place that might be called “caught up”.

Overall, the conference was good. I had some time away from the office to recharge, reflect, and learn. I saw some old friends and met a few new ones. The pre-conference train courses were quite good:

1) Basic GLP – Pre-clinical is an area in which I haven’t worked directly and I think it is best to always stretch at these opportunities and learn something new. I came in second in GLP Jeopardy!

2) Current Topics in GCP (formerly entitled Advanced Topics in GCP) – This is one of the areas in which I currently live and breath; so I heartily enjoyed this session. It included several former/current FDA employees who really added a lot to the course and the subsequent discussions.

During the conference proper, I focused primarily on Clinical and Validation sessions. There were a lot of good ideas and questions at these sessions too, but I really find that I get a lot more out of the intimate, all-day training classes because of the opportunity to really drill down into a topic and explore lots of related ideas and experiences.

Anyway, I’d better get back to it. I’ve been implementing a training program at work related to “Good Documentation Practices for Clinical Validation Projects” that has been taking quite a bit of time. It has generated a lot of good discussion and the response has been very good. Time permitting, I may post some of my support materials.