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Quality Assurance – Risk Based System Design and Auditing

A central part of building out product risk lies in the systems that exist to identify and control variability and error in the product design, input procurement and production processes.

While this is common sense, our experience shows that companies large and small are frequently too content that they have such issues well controlled.  Often even holding quality accreditations can lead to a sense that all is well. In fact too often a critical eye is not regularly applied to ensure that the product risks are fully identified, recorded and systems designed to monitor and neutralize the risk.

Here are some key questions that should have clearly satisfactory answers in any manufacturing organization.  As noted we frequently find that good companies have incomplete systems to cover these points:-

  1. Do you have product design, proof of concept and testing records stored in a methodical manner?
  2. Is change control documentation and revalidation applied to product variations and is it stored in a methodical way?
  3. Is the product design , tolerances and mode of manufacture stored in a product manual or similar document or electronic system and is it used as the basis of production, QA and workforce training and supervision?
  4. Are key suppliers subject to a defined due diligence process both as to quality systems and financial ability to stand behind the supplies?
  5. Are input specifications defined and laid down in detail for suppliers; are supplies subject to inspection on the basis of a statistically valid sampling approach upon delivery? Are key suppliers periodically quality audited on the ground?
  6. Are suppliers contracted to supply to the defined specifications; do the suppliers contract on terms which preserve effective legal recourse and compensation in the event of supply defect?
  7. Has the production process been assessed to identify key control parameters and do systems require sampling and recording to demonstrate on a statistically valid basis that the key parameters are within tolerance?
  8. Are regular audits undertaken to ensure that systems already in place are being observed and that the systems in place remain adequate to control the key design parameters of the product?
  9. Is traceability maintained so that to the maximum realistic extent a given product can without need of packaging be traced back to its date of manufacture , shift , line and inputs .This enables any recall action to be as focused and as low cost as possible.
  10. Is there an effective logging and review system in place so that field problems are captured and analysed to identify any wider quality issues that may be being exposed by field use of the product.

Key Contacts