From Lynn Clyde, BRC Consultant
The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 QMS for clause 7.3.1 Design and Development Planning. Read the scenario to determine if you think it would be conforming or nonconforming, then read the answer and explanation.
Support Information – ISO 9001:2008 Clause 7.3.1
The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine:
a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be updated, as appropriate, as the design and development progresses.
NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization.
Scenario
The auditor was conducting an audit on “Refineries R Us”, an engineering company that designs oil refinery equipment. When the auditor asked to see the design plan, the engineering manager said they didn’t have one because they felt their designs were very simple and everyone knew what they were doing.
Answer
Nonconforming.
Explanation
Regardless of how simple the design process is, the standard requires that there be some type of design plan. The design plan can be one or more documents and can be very complex or very simple, depending on the needs of the organization.
The design plan should consider the following: who should be involved and their responsibilities, major tasks, resources required (facilities, equipment, raw materials, people, training, procedures, tools, etc.), objectives/milestones/deliverables, timing, review frequency, verification and validation.
These requirements are true regardless of your organization’s product or service. (Note that services also need to be “designed”). Unless you have been determined to be exempt from the design requirement, the ISO 9001:2008 standard requires that you create and maintain a design plan.
