[Practical QA Solutions] Co-Mingling QA System Elements & Control Points

Process control points, statistical process control, key check points and critical control points can be difficult to manage, and may not be considered a practical QA solution. There are times when a QA monitoring program compartmentalization overlaps, creating inefficiency and perhaps too much documentation. It is not often this author will mention too much documentation, although overlapping documentation is possible. We strive for consistent products, and recordkeeping also must be consistent. A QA system audit can improve monitoring efficiency and prevent overlap documentation. Make a note today that during your next QA audit you will make a point to look for any overlapping documentation.

What are process control points? Where do they come from? How are they developed? How do they differ from critical control points? Can these control points be co-mingled effectively? They must. Compartmentalization is the breaking down of your entire QA system monitoring into smaller elements. Each element may stand on its own and should be blended into the overall monitoring program. Here are a few examples:

Corporate QA Policy

• Procedures
• Specifications
• Standards

Precepts of Total Quality Management (TQM)

• Seven Steps to TQM
• Pareto Charting

Process Control Points

• X-Bar R Charting
• Out-of-Control Response
• Bell Curve Target

Statistical Process Control (SPC)

• Sources of Variation
• Fishbone Diagram

Plan-Do-Check-Act

• Continuous Improvement

HACCP

• Hazard Analysis
• Critical Control Points

Key Check Points

• GMPs, Security, Etc.

Each element has an intended purpose with desired results originating from a product development cycle. Numerous attributes are based on research and development all the way to the final design: ingredients, formulations, process equipment, process controls, packaging material and finished product performance, just to name a few. Corporate QA policy is a communication tool involving the procedures, specifications/standards and other essential requirements to achieve the desired result.

There is such diversity under TQM today that it has become unclear whether TQM can even be identified as a principle core of some QA systems. Basically TQM is the integration of all processes within an organization to achieve continuous improvement of products and services. The Pareto Rule is known as the “vital few and trivial many.” A few (20 percent) are vital and many (80 percent) are trivial. One can apply the 80/20 rule to almost anything, from the science of management to the physical world: Assuming 20 percent of sources were causing 80 percent of problems would help direct improvement priorities. Pareto charting is an effective method for improvement activities.

Process control points can be a charting of attributes necessary for creating consistency. An entire article could be dedicated to process control charting and interpretation (ditto SPC). For simplicity it will be suffice to say that a process is in control when no points exceed the upper or lower limits. 

The fishbone diagram tool (also know as cause and effect) is another excellent method for improvement activities. Typically this tool is used to reduce variation but can be used for most any problem solving. (To see an example of the fishbone diagram, visit www.qualityassurancemag.com.) The template has a fishbone look, and is used as a checklist to facilitate a problem solving, examining causes having an effect on a specific variation source or problem. 

Another excellent tool for improvement activities is the plan-do-check-act cycle. Follow the oblong circle in a clockwise manner to organize your improvement efforts. (See illustration on page 66.)

It is well accepted that HACCP elevates food safety to a higher level. Critical control points represent the “vital few” designed to prevent hazards (microbiological contaminants, chemical contaminants and physical contaminants) from occurring. The critical control points are not the trivial many, and should be considered specific to food safety and very few in number.

The term key check points might be a new term to some of you. These points are a key for other elements typically found in a QA system such as the GMPs (essential prerequisites for most everything else) and food security, just to name a few.

Each element may stand on its own and is compartmentalized within the entire QA monitoring program. The overall system is in control when the requirements are met and the customer expectations are exceeded. If you measure it, you can manage it. You do this by co-mingling the various QA system elements with all the control points.

The author is an Accredited Associate of The Institute for Independent Business, a Certified Professional Instructor and Certified Instructional Designer and can be reached through his Web site www.qualitycentered consulting.com or by calling 816/436-1627.