A Step-by-Step

Guide to Quality
System Remediation
Larry Stevens

Software for Performance Excellence

 A Step-by-Step Guide to Quality System Remediation

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.
ither 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.

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.
 A Step-by-Step Guide to Quality System Remediation
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:

1. 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.

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

With the backlog or other issue 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).

3. 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.
 A Step-by-Step Guide to Quality System Remediation

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.
 A Step-by-Step Guide to Quality System Remediation

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?

This article was originally published on The FDA Group Website. The FDA Group, LLC and its contributors will not be liable for any
errors or omissions in this information nor for the availability of this information. The owner and its contributors will not be liable
for any losses, injuries, or damages from the display or use of this information.

About the Author

Larry Stevens, RAC has held almost every field position within FDA during his 21-
year career with the Agency. He has over 18 years of experience in the medical
device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for
major class III device manufacturers. He specializes in planning, creating, and
auditing quality systems as well as creating clinical plans, including protocol
development, case report form development, and implementing and managing
clinical trials. He also assists in design control to meet FDA requirements. Larry is
a professional speaker who regularly trains on all aspects of FDA requirements
while offering practical, successful solutions to FDA problems.
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