Planned Deviations: Beware of THIS Compliance Risk!

Sandra Gauvin — Wed, 24 Jun 2009 17:54:07 +0000

In the biotech industry it’s common for a company to use a process known as planned deviations (some companies also call it planned temporary departures) when it’s known in advance they will deviate from prescribed Standard Operating Procedures (SOPs). It’s like knowing a nonconformance is going to happen before it actually occurs.

An example as to when a company would use this process is prior to validation batch runs for new drugs that will be manufactured. A company must submit documented evidence to the FDA that their manufacturing process and controls will maintain the drugs identity, strength, quality, and purity at all times. Typically a company will do a few trial batch runs beforehand to make sure they’ve worked out all of the ‘kinks’ in their manufacturing process. This means they will temporarily deviate from their manufacturing SOP.

Overall, there should be very few instances where it’s appropriate and justifiable to use the planned deviation process because of what it implies….you’re deviating from your SOP’s. However, I’ve seen companies use this process when another process wasn’t working properly. For example, if I needed to get a manufacturing SOP revised quickly but the Document Control process was ‘broken’ so that it took me greater than 4 weeks to get a revision approved….I would initiate a planned deviation and circumvent the Document Control process altogether.

With this mindset, you can see how planned deviations can become excessive and out of control. If the FDA notices an increasing trend and also recognizes that you’re using this process to circumvent broken processes, you may get a 483. I’ve actually heard of companies that initiated a planned deviation because they were deviating from their planned deviation SOP….stop the insanity!

To minimize your exposure to compliance risk, you can do the following:

Create an approval board with senior management so that all planned deviations are scrutinized before given approval. Most people will think twice if they have to get senior management involved.
Create a performance metric that monitors the number of planned deviations per month….this added visibility and will help limit their use. Also, make sure the acceptable monthly target is low. For example, less than 5 per month.
Eliminate the use of planned deviations altogether and use your nonconformance process to document these events.

NonConformance Report: 4 Key Things To Consider

Sandra Gauvin — Fri, 16 Jan 2009 17:42:07 +0000

Write A Good Problem Statement
I’ve learned over the years that writing a good problem statement in your NonConformance Report is probably the most important part of any investigation. If the problem isn’t stated clearly, then it becomes too easy to misinterpret the problem and lead the investigation in the wrong direction. A Good problem statement should tell someone ‘who, what, where, and when’….the ‘why’ will be addressed in the actual investigation.

Start Your Investigation Immediately
Every investigation has an assigned timeframe (specified in your Standard Operating Procedure) in which it must be completed….that means approved and closed out. So the day the NonConformance Report is initiated, the clock starts ticking. If you wait until you have very little time left before you begin, then you most likely won’t complete a through investigation and may find yourself revisiting the issue. Set up a timeline that will include milestones along the way so that you are working on the investigation little-by-little….before you know it your NonConformance Report will be completed and on-time!

Consider All Possibilities When Determining Root Cause
In your NonConformance Report, you want to make sure that you consider everything that may be contributing to the problem and rule each one out until you’ve gotten to the most likely root cause(s)….yes there can be more than one root cause. Sometimes our workload gets a bit crazy and it becomes too easy to quickly jump to a premature conclusion.

Verify That Your Corrective Action Was Effective
Give yourself enough time to evaluate whether or not the the problem has truly been corrected. For example, if the problem used to occur whenever you manufactured product X, then you would want to make sure you have at least three cycles of making product X after your corrective action has been implemented. If the problem hasn’t occurred during the three cycles, then you most likely got to the root cause.

Let me know what your experience has been with NonConformance Reports and if this post has been helpful.

Thanks,
Sandra

Current Quality Blog » Nonconformance

Planned Deviations: Beware of THIS Compliance Risk!

NonConformance Report: 4 Key Things To Consider