Audit Scenario – Product Realization
By Lynn Clyde, BRC Quality Consultant
The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 quality management system for clause 7.1 Planning of product realization. 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 7.1
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
The output of this planning shall be in a form suitable for the organization’s method of operations.
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
When interviewing the operations manager, the auditor asked to see information on production planning. Specifically, she wanted to see quality objectives for every product they made. The operations manager said that they developed quality objectives on a line by line basis but not for each product, although they did have a product specification document for each product. The auditor felt they should have objectives for each product.
The standard states that quality objectives and requirements for the product shall be determined “as appropriate”. This provides flexibility for the organization to set objectives as they see fit. Some companies do this on a product by product basis, on a product line basis, a project basis, or an overall business basis. The extent and type of planning that is done will be dependent upon many factors: size of the organization, complexity of the product and processes, quantity of the product produced, type of industry, regulations, education level of employees, etc.