A Step-by-Step Guide to Quality System Remediation

Gap analyses are critical for assessing the scope, compliance readiness, and resource support within a quality system. By identifying and characterizing system gaps, quality teams get the information they need to develop and implement a plan to remediate them with confidence.

But turning a finished gap analysis into a project plan isn't always easy. While much of the information you need should be contained in the report, you may need to think critically to capture the entire nature of the issues identified.

In general, utilize your analysis as a starting point and build upon each finding to reveal the full scope of a gap and all of its interdependencies. In practice, this means following a few general guidelines to ensure that every action you include in your remediation plan accurately captures the extent of the gaps and lays out a plan to fill them completely.

1. Start with the information you discovered while identifying the gaps

As we said before, very often the details you uncovered about the nature of a gap offer most if not all of the information you need to close it. If, for example, it’s clear that a deficiency was caused by staff being too busy to devote themselves to one of their responsibilities because of another being introduced, the best solutions are evident by the nature of the problem.

Either reallocate existing resources and adjust any project timelines that are impacted so capacity can be maintained, or add the qualified resources needed to fill the gap without affecting other initiatives. In short, don’t overcomplicate or under-complicate your findings. Listen to what your gaps tell you about the nature of their root causes.

2. Consider what is needed to implement each solution from the outset

While some gap remediation can be done internally, other gaps—especially those that point to larger issues within the system that may involve many interdependencies or significant process or resourcing problems—should be highlighted as tasks that will require external resourcing to augment internal efforts.

Note these needs as soon as possible along with the skills, knowledge, and level of experience you’ll need in a contracted resource.

Preparing for a Life Science Validation ProjectGrab our free guide for a set of key questions and checklist items to ensure you fully understand your resourcing needs before starting your search. While the guide focuses on validation specialists, it can be generalized to serve in many different functional areas.

3. Identify known dates and timelines considerations for the project plan

You may discover that some gaps threaten other projects or initiatives within your organization. In these situations (or other situations where time constraints prompt priority action) document who will be needed, when they’ll be needed, and consider how an external resourcing partner could quickly provide the resources you need to protect your project deadlines.

Although these general steps can be used to craft an action plan for closing gaps for which solutions are more or less apparent, gaps that point to more complex problems (and thus more complex fixes) should be treated with a more comprehensive investigation and analysis in order to determine the full scope of the issue and the best path toward solving it.

Backlogs are a prime example of a complex problem that requires a more in-depth follow-up analysis. And while these issues are often the result of a number of contributing factors that need to be untangled and addressed one by one, eliminating them can be relatively straightforward when approached systematically.

Consider the following steps when facing a backlog or use them as a generalized template for addressing other kinds of complex quality system issues:

a. Delineate and confine the backlog (or other quality system issue)

Separate currently scheduled work from backlogged work and define a clear boundary between them, usually with a date. In the case of another kind of issue, the key here is quarantining the problem. This is critical for being able to scope the work needed to eliminate and measure the progress of that work, all while not getting in the way of other ongoing projects.

b. Quantify the backlog (or other quality system issue)

With the backlog or other issues identified and separated, you can measure the true scope of the problem. While different metrics lend themselves to different situations, the result should be in the form of hard numbers. (For example, the number of impacted documents or the hours of work required to process them).

c. Map your processes

Once you have a handle on the size and scope of the backlog or other issue at hand, turn your attention to the processes that may be contributing to it.

Process mapping is the best way to visualize any weak points or bottlenecks that might exist. Keep in mind, the entire root cause probably won’t be something you can circle on a chart. It’s often a combination of factors you have to untangle.

For example, perhaps productivity is stalling despite having brand new manufacturing equipment in the facility. In this situation, the requirements of operating the new equipment may not be reflected in the processes currently in place. By mapping this process out, you can spot the weak link as a resourcing problem in validation, for instance.

Conduct a kind of “mini root cause analysis” to evaluate the effectiveness and relevance of the process and whether you have the right people and the right number of people in place to support it.

“When you map out your processes, you may find bottlenecks where resources are constrained in multiple areas. Your remediation plan needs to capture those bottlenecks so you can resource the project accurately from the start. The plan has to address each individual bottleneck before you move forward.”

Alan Greathouse, The FDA Group

4. Remediate

Based on the nature of the problem that prompted the gap you're looking to close, and its now-quantified scope, there are two practical ways to eliminate it: either get more resources (such as hiring contracted specialists), change the way you do things, (for example, adopting an ad-hoc process for managing the backlog through expedited procedures, shorter forms, etc.), or ideally both.

Use the simple comparison matrix below to understand the relative advantages and disadvantages of each approach and how a combination can offer extreme value in terms of efficiency and corrective/preventive action.

Remediation Decision Matrix Existing Resources Additional Resources
Same Processes

No Progress

The root causes of inefficiency remain while the personnel is tasked with untenable workloads. Changing nothing and demanding more invites cut corners and mistakes while stealing time from current projects.

Short-Sighted Grind

Augmenting your staff with external resources helps eliminate the issue, but at the added cost of operating in a potentially inefficient process. Root causes related to the process remain only to appear again in the future.

Process Improvement

Short-Sighted Efficiency

An ad-hoc or simplified process may allow for expedited review, but at the cost of completeness. Shorter forms and lost steps introduce serious risks. 

Maximum Efficiency, Effectiveness, and Confidence

A combination of process improvement and experienced external resource support results in the fastest, most complete issue resolution while improving efficiency going forward.


5. Review

It’s one thing to get rid of a backlog, but it’s another to eliminate it in a way that prevents it from coming right back. After closing the process gaps and eliminating the backlog, have a meaningful close-out meeting around a few key questions:

  • What caused the backlog in the first place, and was this source external or internal?
  • How could you have seen this coming, and what indicators should you monitor going forward to prevent it from happening again?
  • What new systems, processes, procedures, and resources need to be put in place and are they there now?

Dive deeper or get expert quality system assistance now

Grab our free white paper to learn how to transform a quality assessment into a practical project plan. Inside, you’ll find a strategy for planning the resources necessary for quality system remediation and tips for implementing your plan efficiently from start to finish.

Need help assessing your quality system or closing gaps? Contact us to learn more about fulfilling specific quality and compliance staffing needs.

We help life science organizations secure a wide variety of specialists with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects—all at a competitive rate and backed by a Total Quality Guarantee.

The FDA Group’s large network of quality and compliance resources have extensive knowledge and experience in relevant regulations, guidance, and best practices related to quality system management throughout the regulated life science industries.

Gap Analysis Remediation

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Topics: Quality Systems