Quality Assurance Training/Online Workshops Coming Soon
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I’m thinking about offering Quality Assurance training in the form of online workshops.  Initially, I want to focus on nonconformance and corrective action, and would like to expand the workshops to include other topics.

If I decide to move forward, I’d like to consider some of the issues that you’re currently dealing with, specific to nonconformance and corrective action.

Now’s your time to speak up and share your pain in the form of a comment or you can contact me through the contact page.

You know that dreaded feeling, when you realize that you forgot to put key information in a non conformance report that’s since closed and product has been released?  Do you reopen the report or not bother?

Every time you reopen a closed non conformance report, you’re putting your company at risk from a compliance and maybe even a liability perspective.  That’s because an auditor would begin to question the integrity and thoroughness of the investigation.  S/he would want to know, was the investigation cut short because the focus was on releasing product and not finding root cause? If the missing information were available at the time of the investigation, would the product still have been released?  And if you’re FDA regulated, did you put patients at risk because non conforming product may have been released?

Once an auditor questions the integrity of an investigation, all investigations are then questioned and they’ll start looking for trends to support their suspicions…it’s like opening pandora’s box! And keep in mind that if you have an electronic system, the audit trail will document when and how often a record was opened, and what information was added, so it’s even more obvious to a savvy auditor.

To minimize your risk, you’ll first need to know how often records have been reopened in the past.  If you have an electronic system, then you should be able to quickly run a report.  For paper systems, you’ll unfortunately have to manually look through each report.  Any reopened records found will have to be re-evaluated through the eyes of an auditor to determine the severity of the situation.

For example, was the record reopened to fix grammar and typo errors or were lot numbers affected by the non conformance not included in the initial investigation?  Either way, you’ll need to know how you’ll handle the situation should an auditor ask questions.  Moving forward, you should consider how you’ll control the reopening of closed non conformance reports and write a procedure documenting the control…this applies even to companies that provide a service as opposed to a manufactured product.

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.