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7.3.5 D & D Verification
Perform verification in accordance with planned arrangements (see 7.3.1) to ensure that d & d outputs satisfy d & d input requirements.
Maintain records of the results of verification and any necessary actions
7.3.6 D & D Validation
Perform validation in accordance with plans ( see 7.3.1)
Ensure that the product meets requirements for the specified application or intended use, where known
Complete validation before delivery or implementation (wherever practical)
Maintain records of the results of validation and any necessary actions
Key Explanation Points and Tips:
ÞProduct design Verification includes - design reviews (see 7.3.4); comparing the new design to a similar proven design if available; performing alternate calculations; performing tests and simulations; reviewing the design documents before release, etc.
ÞVerification is checking product or process to input requirements, whereas validation is checking product or process is suitable for its intended use - does it perform/function in the way intended by your customer or your organization.
ÞManufacturing process design verification include - design review (see 7.3.4); process capability studies; testing various process parameters; performing tests and trials; reviewing the manufacturing process design documents before release, etc.
ÞProduct and manufacturing process validation includes - design reviews; comparison between customer requirements and internal development plans; d & d validation against customer requirements and d & D input requirements; corrective action and lessons learned from documented process failures and product nonconformities
ÞIf you outsource any part of your d & d activity, then you must exercise the same controls required by clause 7.3 on the outsourced work and the organization doing the work, had it been done internally.
ÞYou must keep records for both verification and validation activities.
7.3.7 Control of D & D Changes
Identify and maintain records of changes
Review, verify, and validate the changes(as appropriate)
Approve the changes before implementation
Evaluate effect of changes on constituent parts and product already delivered
Maintain records of the results of such reviews and any necessary actions
Key Explanation Points and Tips:
ÞMake sure your process for d & d changes follow appropriate steps of clause 7.3 (define plan, have inputs and outputs, verify and validate) to the extent necessary to meet customer requirements and control product, quality and business risks.
ÞChanges may come from internal, customer or regulatory sources. Get all requests for product or manufacturing process design changes in writing from your customer!
ÞImpact of the change must be evaluated on - materials used; design process; manufacturing process; characteristics and use of developed product; regulatory compliance; cost; etc.
