This is a special issue of the Insider Newsletter only for paid subscribers. We’re republishing one of our most popular white papers and webinars on planning a quality system remediation project following a gap analysis or audit.
We interviewed our own Alan Greathouse, The FDA Group’s Senior Director of Quality and Service Assurance, who has managed countless remediation projects and seen and solved many challenges related to resourcing and project management. Larry Stevens, a former FDA Investigator (among many former FDA roles) and consultant presented the accompanying webinar we’ve posted here.
If you need remediation support, learn more about how we can help, and get in touch with us to get the conversation started.
Introduction
A completed gap analysis is like a travel itinerary for your quality system. Just like vacationing in an unfamiliar place, you know where you want to be but need a guide to show you exactly where you are, which direction you need to go, and what you’ll need to do to get there.
If your analysis was thorough and detailed, much of what you need to develop this remediation plan is already in front of you. The information you gathered during the analysis can largely be re-tooled into a set of actions for filling system gaps. That task is relatively straightforward.
What isn’t so obvious, and where many teams get stuck, is what comes next: resourcing and implementing the fixes. These steps are rarely as easy and straightforward as they seem and can involve tough discussions about capital and capacity that are often under-addressed or avoided altogether. Too often, firms rush into planning and executing remediation without taking stock of their resources and comparing them against the resources the plan demands. Without this critical planning step, busy schedules, competing priorities, and mismatched skill sets can all converge, bringing the project to a screeching and expensive halt.
The good news: all of these threats can be mitigated from day one with a healthy dose of planning guided by strategy and a partner that can provide quick, flexible access to the resources you need to get projects done on time and on budget.
That’s precisely what this guide this for. We’ll explore exactly where quality departments get stuck during the planning phase following a quality system gap analysis and provide a strategy you can employ to ensure you have all the resources you need to be successful from the outset.
Before we jump into resourcing, however, let’s take a moment to run through a few tips for conducting a gap analysis, explore two quality system gaps that are serious red flags to watch out for, and discuss what an effective remediation plan should include.
A few tips for conducting a gap analysis:
A gap analysis should always result in the action items required to bridge the gap between the current and desired state. However, it should never be substituted for more detailed assessments that should be carried out once the remediation project is underway.
A gap analysis should be performed at the preliminary stages of any change-related project.
While trying to obtain information about the elements involved in gap analysis, always use reliable tools such as SWOT, Fishbone, McKinsey 7-S, etc.
Data obtained should be quantifiable whenever possible so it can be verified if needed.
Information collection should be focused on the processes, workflows, information, and interdependencies rather than individuals.
The end goal or future state and the respective scope of the change should be carefully defined. Any mistake in doing so might turn the analysis in an altogether different direction.
Reviewing Your Gap Analysis Report
Once you’ve completed your gap analysis, you should have a report that clearly identifies each gap in the level of detail needed to close it. At this point, some corrective actions may be obvious. Others may be more complex and take some planning to formulate.
When preparing to create your remediation plan, a healthy dose of due diligence is necessary to avoid showing up at the next meeting, only to discover that nothing has been done to address the gaps you found. After the analysis is complete and the subsequent report has been sent to management, the following steps should typically look something like this:
Follow up with the management team to ensure they fully understand the findings.
Make sure the project lead prepares a timely, complete remediation plan to address the gaps you’ve uncovered.
Determine the feasibility of your existing resources to implement the approved plan, identify the people who will initiate and implement it, and/or secure the external resources needed.
Implement the plan.
Verify success, determine the need for surveillance audits, and put a plan in place to schedule those with the appropriate resources.
Two Common “Red Flag” Gaps to Watch For
Before diving into resource planning, let’s step back to discuss a couple of quality system gaps that, when detected before or during a gap analysis, almost always point to an underlying resource or process deficiency requiring serious attention (and typically many resources and man-hours to fix).
Backlogs
Backlogs are almost always a sign of either a process problem, a resourcing problem, or a dangerous combination of the two. While a backlog is usually apparent, knowing how to get rid of it is much less so. This is especially true for lengthy backlogs and those that have gone unaddressed for some time.
Quality departments should be especially wary of a few types of backlogs that, as experience tells us, nearly always represent the tip of a much larger iceberg of issues lying underneath the surface. Backlogs in analytical testing, CAPAs/deviations, and customer complaints are three examples of these high-priority areas that should always be a cause for concern given that lapses in oversight could lead to serious risks in both regulatory compliance and product safety.
A backlog of quality documents should also prompt you to put processes and people under the microscope. Especially in busy, chronically understaffed units, competing priorities can prevent managers from reviewing and signing off on key reports in a timely manner. In the case of a backlog of batch records, for example, a back-up of documents may be directly causing a back-up of products, thereby creating a potentially serious yet completely avoidable financial and compliance liability that may or may not be on anyone’s radar.
While it’s impossible to capture all the types of backlogs that should serve as warning bells for your system, we’ll lastly mention long-standing investigations as another gap to be particularly careful of. Both in gap analyses and internal audits, inadequate and/or delayed investigations remain one of the most persistent issues affecting quality units and a frequent red mark on gap analysis reports. The takeaway is to be proactive to ensure that if a red mark is spotted, it’s on your gap analysis, not the FDA’s.
The causes of these and other types of backlogs shouldn’t be surprising. As we mentioned, teams have a lot on their plate and may be dealing with long staffing or skill shortages. As a result of these and other constraints that put pressure on teams and their timelines, the intensive investigations and diligent corrective actions that are so critical after a gap analysis or other quality system assessment are often exactly where corners are cut among other competing priorities.
But, as we’ve observed firsthand in quality units large and small, the ironic root cause of poor root cause analysis isn’t the nature of the work itself but the quality of the processes and people that support it.
Inefficient or inadequate investigation processes often get compounded with unqualified writers and reviewers to create the kind of quality management gaps that pose serious compliance and safety risks when problems are allowed to go unresolved at the root. Remediation in these cases often starts with simple questions that, when answered honestly, can prompt meaningful steps toward improvement that can alleviate these lingering burdens.
“Issues with investigations come up a lot. A consistent backlog here almost always points to an underlying process or people problem that when left as-is, only compounds to create a bigger, more expensive, and risky gap to fill. The questions we use to diagnose and treat the problem usually aren’t complex.
‘Is your investigation process as efficient as it could be?’ ‘Are the people responsible for conducting, writing, and reviewing investigations qualified to do so?’ ‘Is there a documented training system in place to ensure qualified resources support the process?’ ‘Have leaders made sure their teams are adequately resourced to conduct and review investigations thoroughly?’”
— Alan Greathouse, Senior Director of Quality and Service Assurance, The FDA Group
Procedure vs. Practice
In addition to backlogs, another major red flag worth noting for how frequently it shows up and how much remediation it can require is any quality system discrepancy between procedure and practice. When a procedure is routinely not being followed or doesn’t match what personnel is actually doing, it’s usually the procedure’s way of telling you it needs attention.
Closing the gap here requires some investigation to determine the exact issue. The best and most universal advice here is to start asking the questions that reveal the most common root causes:
Is the procedure still in use?
Is the procedure out of date?
Is the procedure unnecessarily long?
Is the procedure unclear, complicated, or difficult to understand?
Is the procedure hard to find or locate?
Is the procedure currently controlled or uncontrolled?
Is the procedure too generic, general, or simplistic?
Is the procedure incorrect, wrong, or poorly written?
Is the procedure poorly designed or hard to navigate?
Is the procedure inconsistent in format from others?
Developing a Remediation Plan to Close Quality System Gaps
As mentioned before, the gap analysis report should do much of the heavy lifting in crafting a plan to close your identified gaps. Utilize your analysis as a starting point, building upon each finding to reveal what’s needed to completely solve the problem. 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:
Inform your remediation plan using the information you discovered while identifying the gaps. As we said before, the details you uncovered about the nature of a gap often offer the best way to fill 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.
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 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.
Identify known dates and timeline considerations for the subsequent project plan. You may discover that some gaps threaten other organizational projects or initiatives. In these situations (or other situations where time constraints prompt priority action) document who will be needed and when they’ll be needed, and consider how an external resourcing partner could quickly provide the resources you need to protect your project deadlines.
