Blog, ISO 9001 Requirements

Total Quality Control – Product Control

When A.V. Feigen the orginator of Total Quality Control talks Product Control, what is he referring to?  Does Quality Control Mean more Inspection?  The four main elements of A. V. Geigenbaums approach to Total Quality Control are as follows:

  1. Design Control
  2. Incoming Material Control
  3. Product Control
  4. Special Process Control

So what does product control really mean in a manufacturing environment?  I have discussed Design Control Principles for Total Quality Control, and Quality Assurance – Incoming Inspection.  The manufacturing of product is the next step in the Total Quality Control process.  The control of manufactured product is critical in the process of total quality control.  If you have a robust design and raw materials which meet requirements, you must ensure the manufacturing process will consistently produce product which meets the customer requirements.  This is typically verified through product validations.  Inspecting quality into the products can result in excessive scrap and failures in the field.  Therefore, validating your product is a worthwhile venture.tqm

Product Validations are sometimes conducted throughout the design phase.  Product Validations can be conducted on both prototypes as well as finished product manufactured for end use.  Validations should be conducted prior to release to ensure the end users requirements will be met before product release.  The use of the final raw material designs and manufacturing work instructions should be used to produce product for validation testing.

Some typical steps to perform Product Validation are as follows.

  • Assign a Validation Team and include the Quality Department to ensure all quality and regulatory requirements will be met in the scope of the validation.
  • Develop a Validation Protocol or Test Plan to predetermined criteria which ensures the product will meet customer needs and product specifications.
  • Have trained resources to execute the plan validation plan so the requirements are not misinterpreted.
  • Run pre-production pilots to debug manufacturing processes and tooling.
  • Validate all manufacturing work instructions, finished product, user manuals, instructions for use, and service manuals etc.
  • Conduct all required Inspection and testing to an approved statistical sampling plan.
  • Schedule Design Reviews to ensure project in under control and the plan is acceptable to all departments involved in product release.
  • Complete any necessary revalidations or corrections if product or process failures occur
  • Ensure the process produces acceptable product consistently to the predetermined criteria outlined in the validation plan.

The subject of validation is much too large to address in this article.  If you are interested in learning more contact me.

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