Reaching Understanding

The standards are written in a foreign language: Standardese! We help you understand and learn to speak Standardese so that your registrar and the audit are clear.

We sit with your people and cover each word of the standard, using examples from your operation. We are working to help you see what the standards writers are saying, with explanations why they use the language they do. It is confusing.
For example, the important and simple but important word "Shall" is used in 4 different ways:

1. "Shall" specifies something you have to do, as in 5.6.1 Management Review General "Top management shall review the organization’s quality management system, at planned intervals..." This tells you to have management reviews when you planned to have them.

2. "Shall" identifies something you might try to weasel out of so that the auditor can shoot you down if you engage in that specific undesirable (in the eyes of the writers) activity. However, there is no specific thing you have to do, as there was in 1 above. For example, 5.2 Customer Focus "Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)." This was not a part of management in the '94 standard, but was added to allow the auditor to pin it on the Boss when they discover that the organization knows it is shipping junk.

3. "Shall" tells you to do something but you don't have to, since there will be further detail saying more about the subject, so simply point at that more detailed requirement and ignore it. "Shall" is often used in this meaning in "General" sections. For example 8.1 Measurement General "The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate: a) conformity of the product..." looks like you have work to do, but those who have peeked ahead know this same topic will be covered in more detail in section 8.2.4, where you have to do the work.

4. "Shall" tells you to do something which you have already been told to do. This is mostly in ISO/TS 16949:2002, and the requirement is repeated to make sure that the auditor checks it and it isn't missed in the sampling. For example, TS Section 7.4.3.2 Supplier monitoring "Supplier performance shall be monitored through the following indicators: delivered product quality; customer disruptions including field returns..." Back in section 7.4.1 Purchasing process "The organization shall evaluate and select suppliers based on their ability to supply products in accordance with the organization’s requirements..." In my book this covers "product quality and customer disruptions", but I don't know about how you treat your suppliers. So the "shall" is a repetition and can be answered once.

The Midwest professionals can communicate well with shop floor personnel with little formal education, but a lot of manual know-how as well as with the MBAs in the front office and PHDs in the lab. We use examples from your business to make the points.

Midwest always starts with the clearest parts of the standard and works up to the most difficult. Most people find describing what they do to in production pretty straight forward, so we start with 7.5 production. We end up with the definitions of your processes, their sequence and interaction in section 4.1; by this time we have covered what you do and that answer is clear. But start at 4.1 and typically you get wrecked!

We also go over it again and again in the Rough Cut, Fine Cut and Dress Rehearsal Audits. It is often on the third time we cover a topic that we hear the nickel drop and that "aha" moment happens.

Our goal is that you understand the requirements so that you can fight with the auditors and continue to develop your system. It is very frustrating for each person to tell you definitively that a section of the standard means "black", and the next expert says equally definitively that it means "white." Eventually you get tired of hearing what others think and do the thinking for yourself. So when the auditor pushes you to say something is "black" you will know how to (politely) push back and show how the words really do say "white." Then you have graduated from our class. You understand, and no one can take that from you.