QUALITY SYSTEM DEVELOPMENT: management review (risk assessment)

The demand for risk assessment and risk management in the current quality management standards can immobilise the most dedicated executives, not to mention the quality management representatives. Out of pity for their dilemma and misery I offer the following questions, which are extracted from the Qualidoc Quality System Internal Audit Checklist at www.qualidoc.co.uk.

Are the quality system, quality objectives and business objectives reviewed regularly FOR RISK against the following:

• Development of innovative product or service, including software?
• New or strategically important customer acquired?
• Loss of strategically important customer?
• New techniques developed, including software?
• Significant changes (planned or not) in the business?
• Process changes?
• Transfer of work?
• Change of supplier where parts become obsolete or otherwise unsatisfactory, especially where counterfeit parts might enter the supply chain?
• Changes in regulatory, statutory or quality management standards?

These are all questions based on my experience on the shop floor and also verified information received from my valuable contacts in aerospace and other heavy industrial users having to meet stringent quality management requirements.