The key to success is knowledge – with more knowledge about requirements – the less mistakes there will be.
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Tammy Pelnik gives her view on why knowledge matters in GMP and QMS
How I see it
 
Living in the real world, I am certain each and every day that there is a chance something may go wrong. An unexpected “oops” because stuff happens! It’s a cold, snowy day, someone slips and falls on the sidewalk, or a flight is delayed because de-icing is essential for safety’s sake and that takes time. I accept the challenges every day events present, and look for opportunities to reduce the likelihood of these potential mishaps. Considering the weather conditions before selecting footwear, might be enough to prevent today’s slip and fall. And if they are not, maybe next storm I reconsider: is it time for new or different boots?

Quality Management System standards have the same pragmatic approach. Rather than hope that nothing will ever go wrong, or treat each incident as special case, simply establish a systematic process to help identify, evaluate, and resolve issues that could cause ongoing problems with your product. This aspect of your QMS is another case of accepting the real world for what it is (i.e., stuff happens), and striving to make improvements where they’ll really help. The concept of Corrective Action and Preventive Action have persisted and matured.
In practice, too few are enthusiastic to contribute to CAPA at work. I believe all the reluctant participants are the result of organizations’ QMS decisions around how to implement their CAPA processes. Maybe the authorities afforded staff who are assigned CAPA work are insufficient, or onerous data management systems overtake good CAPA work with tedious data entry requirements, or not enough time is available to take care of the “extra” CAPA work on top of all their other responsibilities.
- People don’t really disrespect the CAPA process as a concept, but they don’t believe in the way CAPA has been implemented.
 
People don’t really disrespect the CAPA process as a concept, but they don’t believe in the way CAPA has been implemented. In other words, bad choices in designing and implementing the CAPA process can lead to a lack of enthusiasm, and may in fact result in inefficiencies that cost a company lost resources. But it doesn’t have to be that way.

That’s why Knowledge matters.
My big why
 
Having the opportunity to help someone set aside their pre-conceived notions about the problems with (their version of) CAPA, and instead see the power CAPA could hold in improving their overall business, that makes my day! Leaving people with real ideas to truly streamline, simplify, and thereby improve CAPA effectiveness, that makes for a truly satisfying learning experience for everyone. I firmly believe that CAPA is a pillar in an efficient and effective QMS.
Did you know?
 
Even though the basic CAPA requirements for regulated products have been stable since the first standard, industry practice has changed over time, and regulatory expectations have expanded. Industry expectations for a fully integrated, risk-based QMS are not the same today as they were in 2005. A CAPA process that was considered robust 15 years ago but has not changed since then will probably seem inadequate to regulatory authorities today.
Tammy is an industry expert, a quality systems consultant and President of The St. Vrain Group, Inc., a management and technology consulting firm. Tammy is noted for her subject matter knowledge, expertise in presenting engaging courses, and her frank, direct approach to addressing attendee questions throughout each class.
 
How you can get it
 
 
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