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:

1. 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.
2. 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.
3. Eliminate the use of planned deviations altogether and use your nonconformance process to document these events.