Product Realization Planning

Product realization is the ISO 9001 term for product and / or service provision.  ISO 9001 section 7.1 states that: “The organization shall plan and develop the processes needed for product realization.”  A quality plan involves the following:

• Quality objectives
• Product requirements
• Documented processes
• Resources needed to produce, monitor and test the product
• Required verification, inspection, monitoring and measurement procedures
• Records needed to show that the processes and the resulting product meet requirements

Quality objectives should be consistent with the organization’s quality objectives.  Product requirements must be consistent with the outputs of the design process.

Documented production processes are not required, but it is a good idea to document how the processes that produce the product interact. A flow chart is a good way to show how the manufacturing of the product will occur and where the inspection points will be.  Documented inspection procedures which describe the product requirements, the inspection methods and tooling to be used, and the frequency of inspection assure a consistent inspection process.

Once the production processes are determined, it should be easy to determine the resources needed to create the product including:

• Manufacturing equipment
• Tooling
• Personnel needed to perform the work and do the inspection
• Inspection equipment and procedures
• Records needed

Inspection records are required.  The organization must be able to show that the product meets requirements, and the way to do this is to record inspection results.  Records should show the features inspected, the specification for each feature, the values obtained, the gauge / tool number used to perform the inspection, the inspector, and the date / time of inspection.  Inspection records can be a critical input to corrective actions, and analysis of data necessary for continual improvement.

For more information visit www.rosehillsystems.com

On-site Supplier Audits

In my recent post in March on Supplier Evaluations, I addressed supplier self-assessment questionnaires.  Questionnaires are good, but sometimes it is good to visit the customer.  What should one do when on-site at the supplier?

A client recently asked me how to conduct an on-site process audit of a supplier.  He was visiting the supplier anyway, so it made sense to him to conduct a process audit while there.

When doing such an audit, I like to start with known purchase orders (open and closed) and follow those orders from the point where the PO is received by the supplier to the point where the product ships.  Asking the supplier to retrieve records about a closed order also helps to assess the supplier’s record keeping.

To assist the client, I came up with 10 areas of questioning.   The questions follow a customer purchase order through the sales order, design, procurement, production and inspection processes.  They offer a pretty good idea about the supplier’s processes and how well aligned with the standard they are.  Such an audit can be conducted in a couple of hours and give a pretty good idea of the supplier’s compliance with ISO 9001 requirements.

You can find the questions here , in the advice section of my web site.  For questions, or additional information, visit www.rosehillsystems.com.