HACCP for Medical Device and Pharmaceuticals

By ETQ on December 20, 2010

I recently was speaking to a group of folks on the different ways to mitigate risk.  While this may not seem like “exciting” dialogue, it actually provoked an interesting thought – while many organizations interpret Risk factors differently, it seems that from one industry to the next, they tend to use a singular method.  One group uses FMEA exclusively, another uses HFACS or some human error risk, another uses HACCP, and so forth.

Most of these risk concepts evolved out of each other.  In fact, I recently learned that FMEA (Failure Mode Effects Analysis) actually spawned out of World War II, as a method to avoid errors in ammunition, and later, rocket technology.  Once NASA was formed to jump into the space race, FMEA was used as a framework for the HACCP (Hazards Analysis Critical Control Point) standard (because food was a big deal for astronauts, apparently).  It was only after this that HACCP became the method for food safety, and FMEA for manufacturing.

However, HACCP is not only a great method for identifying and mitigating risk, it does not need to be limited to just the food industry.  In fact, Pharmaceuticals and many Medical Devices can not only benefit from a HACCP methodology, but many already are using it in their Quality Management System.  Let’s quickly break HACCP down for a moment:

1.  Conduct a Hazard Analysis:  Whether you processing food, making a medical device or manufacturing drugs, it is important to identify at which points in the process potential hazards exist.  By identifying these during the process, you can catch potential risks before the “end of the pipe”.

2. Identify Critical Control Points:  In any production process, there are points in which specific controls can be applied to ensure risk is reduced to acceptable levels.  The hazard Analysis helps to uncover these points, and by using Critical Control Points(CCP), you can set the risk limits.  CCPs were actually based on FMEA – the concept is very similiar.

3. Establish the critical limits of the control:  Again, this is a common concept in any industry – it just depends on the industry.  Each process will have it’s own limits based on their quality standards, regulatory requirements, and type of process.

4.  Monitor your CCPs:  Some industries may vary on the level of monitoring, especially on the nature of the product, but the important thing is to understand that for every hazard, you need to control it, control it to an acceptable level, and make sure you monitor it on a frequent (or constant) basis.

5.  Corrective Actions:  If I have to explain this one, then I think you’re reading the wrong blog.  But anyway, whether you make a syringe or a sweetener, you need to take Corrective Action on adverse events. Corrective Action is the heart of any Quality system – it helps to foster a systematic method for solving problems and continuous improvement.  This is a universal concept across all industries.

6.  Establish record keeping procedures:  All industries need to have documentation in place, in order to maintain proper control. It’s all about proof – show that you’re monitoring your CCPs, you’re following your procedures, you’re training employees, and so forth.  Every industry and methods includes Document Control, and HACCP is no different.

7.  Verify – Ensure the HACCP System is Working as it’s Supposed to:  Just like any process-based compliance method, it’s important to review it and make sure is working properly.  HACCP Plans are reviewed as often as needed (quarterly, annually, etc), to reflect the organization’s regulatory requirements.  Most organizations have an auditing program in place, and this usually involves internal processes.

The common thread between Life Sciences and Food is that the ultimate product is directly affecting the health and well-being of an individual.  So, it makes sense to implement a system that benchmarks Quality at every step in the process, not just towards the end.  Back in WWII, the idea was that ammunition was a critical element, and to identify potential hazards using FMEA was better than their original idea:

Now, we look at these systems as a means to control quality and safety, not only at the end point, but throughout the process.  With all the media buzzing around recalls and product failures, it is critically important to get quality right the first time, and the HACCP methodology is a great example of how one industry’s bread and butter can be another industry’s hearty meal.