Improve Your Quality Records
Computer technology has done amazing things since the first APQP document was published.
Delegating and nodding in agreement is not the way to get things done.
“Everyone delegates. Everyone nods agreement. Nothing changes. Sometimes this not discussing the ‘how’ is very purposively avoided. How many times have you heard in a crisis, ‘I don’t want to know how you get it done, that’s your problem. Just do it.’ If management is to improve their organization, they must change the process. This means that they cannot accept conference room promises, but must work directly with their people on the process, the how and the why. During this period of transition, everyone must be willing to learn. There is no room for fear of learning. No one is too senior to be involved in the how.” This quote comes from “The Deming Route to Quality and Productivity – Road Maps and Roadblocks” p. 139 by William W. Scherkenbach.
So when is the last time you thought about Advanced Product Quality Planning and Control Plan (APQP) in regard to quality records? Going hand in hand with APQP is the requirement for TS16949 certification. TS16949 has evolved over the years to have all the best practices and lessons learned pertaining to quality management systems. Thus, to have effective APQP, there should be quality records. Section 4.2.4 of TS16949 is about control of records. This section states that:
“Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.
The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.
Records shall remain legible, readily identifiable and retrievable.”
During the past two decades, from 1993 to the present, computer technology has done amazing things since the first APQP document was published. The amount of data that is generated and collected is monstrous. How would your records meet the requirements?
In auditor talk, quality records are really the evidence that APQP has been executed. APQP states “Product quality planning is a structured method of defining and establishing the steps necessary to assure that a product satisfies the customer.” So, what are the records of your product quality planning?
APQP has sections on:
- Plan and Define Program
- Product Design and Development
- Process Design and Development
- Product and Process Validation
- Feedback, Assessment and Corrective Action
- Control Plan Methodology
So APQP covers your product planning; all your product engineering processes and manufacturing engineering processes; the validation of the product design and also the validation of how the design gets manufactured; how you detect and fix problems during these processes; and the issues and corrective actions that happen during these processes.
Examples of quality records are: program definition and requirement documents, product change requests, bill of material lists, product prints (both 2-D and 3-D), validation and verification test results, design review documents, virtual analysis reports, some types of meeting minute, run at rate results, PFMEAs, DFMEAs and documentation of issues and corrective actions.
So where do you start?
To understand the “how” of your processes, one needs to find the quality records of your processes. Look at a particular record of one of your APQP processes. How is this record generated and used? Can you find all your records? Can a new employee understand where to find them easily? Is there only one place to store a particular type of record? Or do some departments store similar types of records in different types of databases? How do you know you have the latest record for a particular item?
Walk the virtual process of the quality record from a finished one backwards.
In the book “Learning to See: Value-Stream Mapping to Create Value and Eliminate Muda” (p. 14), Mike Rother and John Shook state, “Always collect current-state information while walking along the actual pathways of material and information flows yourself….Begin at the shipping end and work upstream, instead of starting at the receiving dock and walking downstream. This way you will begin with the processes that are linked most directly to the customer, which should set the pace for other processes further upstream.”
Start at the end of the process you pick by looking at a quality record and look at how it was created and used in a particular process.
Does each area of the company understand what their quality records are? Where are they located? What processes generate them? Are they only retained in one area? Is a record kept in multiple areas? On everyone’s individual hard drive? On special drives that one needs a special decoder or the right person in order to get access?
Many companies create what is called a quality record matrix that is an Excel type list that catalogs for each record its identification, storage, protection, retrieval, retention and disposition of records. These record matrixes may be subdivided by departments. Often different departments within a functional area have the same type of records, just different types of products or services. Keep the definition at a high enough level that you can see how different areas use the same processes just for different commodities, services or product lines. It will help to simplify your processes and also identify your main “virtual” processes.
Understand the quality records of your company. Understand how they are generated and by what processes. Look at actual records. As Deming would say, “You can expect what you inspect.”
So you need to look at the content of your records and the integrity of what they contain and say in order to build robustness into your processes. The concepts of quality management systems standards such as TS16969 are tried and true learnings. It’s very similar to athletes doing push-ups and sit-ups. It’s core work, and nobody really likes to do them. It’s painful if you don’t do these types of strength building exercises for your organization. If you don’t, your overall performance suffers, you’re not as good as you could be, and you put yourself at risk for catastrophic injuries.