7.5 Production and Service Provisions

7.5.1 Control of production and service provisions

This may be the most important clause in the ISO 9001 standard. The standard is based on this concept: If you control the input to your process and make sure it is good, the output has to be good. Why? Because the process consists of the input, that’s all there is. If it is good going in it will be good coming out. Therefore, this clause tells the company the things they need to do make sure the input is okay.

7.5.2 Validation of processes for production and service

This requirement is for processes where the output can’t or isn’t inspected or tested to see if it is okay. You have to make sure that everything in the process is controlled. Like how to do the work, what equipment and material must be use. It could even require the operator(s) be certified to run the operation. Once that’s all settled, it has to be checked on from time to time or what the standard calls ‘revalidation’.

7.5.3 Identification and traceability

The standard defines quality as conformance to requirements. Earlier we discussed the importance of clearly defining the customer’s requirements that are measurable. This clause reminds us it is necessary to always keep these requirements in mind.
As items move through the steps of processing, we need to know if they are ready for the next step. As obvious as this seems, at one time companies didn’t know what was what and where it was because it wasn’t always clearly identified.

The other condition in this clause is about traceability. This means we can look back and find where the materials came from, when it was made and who bought it.

7.5.4 Customer-owned property

The first thing you need to ask is “Do I have any customer owned property?” This can be anything the customer retains title to. It can be parts, materials, tooling, packaging and labels. Also include is intellectual property like blueprints, methods, formulas and recipes.

You are responsible for the care, custody and control of customer property and that means keeping it safe from damage and loss. It can also mean keeping it clean, properly identified and in useable condition.
If anything happens to it you must tell the customer and keep a record of the problem.

7.5.5 Preservation of product

You have to be careful in handling the materials and goods while being processed. You must use the appropriate containers and fillers so items won’t be chipped, broken or bent. Reducing the distance between operations inside the plant and fixing cracks and holes in the floor so the towmotors aren’t bouncing your stuff around like an eight-year old on a trampoline may be needed.

The final stage is seeing the goods are packaged correctly for the method of shipping; truck, air or sea. Sometimes a supplier doesn’t get to choose the shipping method or the carrier because the customer is paying the freight. Unfortunately, you are still responsible for seeing the goods arrive at your customer’s in good shape. We need to always keep in mind the customer pays for the product quality at their dock, not yours.

7.6 Control of monitoring and measuring devices

A lot people think this clause is about inspection gages and instruments. It’s not. It’s about data, good useable data. If we are to make a decision regarding the quality of something we must be able to rely on the data we use to make the decision. In order to feel comfortable about the data we have to be comfortable about the methods used to gather the data. This does include making sure the gages and instruments used in the data gathering method are stable and reliable.