ISO 9001 Quality Manuals

Posts Tagged ‘Process Control’

Some organisations use up huge resources setting up rigorous final product testing regimes to ensure that products meet the specification and customer requirements. The problem is that whilst this stops poor quality product from reaching the customer it actually is of little benefit to a business.

The real secret to a successful quality management system is to control the process. Some people call this quality assurance, in essence as a business you should concentrate your resource at stages where you can still take corrective action to produce a satisfactory product. Yes you need to confirm the final product meets specification but if you have control of the process then less resource is required at the final stage to confirm this.

The problem lies with figuring out what you should do to control the process. The easiest way to do this is to carry out a Quality HACCP analysis. This will indicate to you the key points in the process where you can apply controls. You may already have a HACCP which you can use as a template.

Principle 1 If you don’t already have one, prepare a flow diagram of the steps in the process. Conduct an analysis by identifying potential quality hazards.  Assess likelihood of occurrence of these defects and identify control  options.
Principle 2 Identify the Quality Control Points in the process using the same principles as the decision tree.
Principle 3 Establish quality limits, which must be met to ensure each Quality Control Point is under control.
Principle 4 Establish a monitoring system to ensure control of the Quality Control Point by scheduled testing or observations. Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular Quality Control Point is moving out of control.
Principle 6 Establish procedures and records appropriate to the Quality Control Points and their application.
Principle 7 Verify that your Quality Control Point system is working effectively. This can be done in the normal way but also you should measure the difference in conforming final product.

I don’t really like to use the phrase Quality Control point as I much prefer to use the term quality assurance but what you should be generating in effect is Process Quality Control points which is different. Your system should increase the effectiveness of your process and also identify weaknesses and areas for improvement. For instance we went through this analysis and decided that one of the key quality control points in the filling process was capping and sealing. It wasn’t really a food safety hazard but it was really annoying if you were a customer and the stuff leaked all over your car. So to improve our performance we didn’t carry out more extensive tests to make sure less defective product got to the customer, what we did was put controls and checks in place to ensure a better capping and sealing performance. We put in place procedures to check capping torque settings prior to start up and checks on sealing head temperatures. There were many other things we implemented as well but the long and the short of it was that we reduced customer complaints and product wastage with the same resource.