In this issue I want to share some experiences with two special quality management standards with completely different backgrounds but in the end striking similarities in their deployment: automotive companies and medical devices.
To understand the strategic value of the special requirements it is good to first look at the background of the standards. Who took the initiative, for whom have they been developed and what is the result of the use of these standards?
Let’s first look at the automotive industry. In the second half of the previous century especially the Japanese car companies flooded the market with low-priced, high quality cars. To respond to the challenge the European and American manufacturers started a number of initiatives to improve the quality of their products. Early on they identified that the quality received from suppliers is crucial for quality and efficiency during assembly of the final product, the complete car. Finally this insight resulted in a single international standard detailing all requirements for a (potential) supplier for being considered to supply to the large automotive companies. The standard puts high emphasis on process control, both during production and during design and release, customer satisfaction, continuous improvement and complaint handling.
One of the results of these strict requirements is the almost complete disappearance of the “Monday morning car” (that car that always has a problem). Another result is the wide adoption of a number of automotive quality management methods, also in other industries. Consider the 8D method for complaint handling and problem solving and the FMEA method to identify and eliminate risks in products and processes.
The requirements for medical devices and materials have a completely different background. In the medical sector quality is mainly focused on avoiding risks for the patient. In many countries there are stringent laws for what a doctor is allowed to do or not and for what risks a patient may be exposed to. At the same time doctors want to give their patients the best possible care and want to use the best equipment and materials available. Often such equipment has to be imported from another country, where the rules and regulations can differ from those in the importing country. In the quality standards for medical equipment the regulations have been combined so that they are acceptable to all inspections and thereby enable the use of approved equipment in the various countries. As a consequence the medical standards put high emphasis on thorough documentation of product characteristics and use, elimination of risks and strict process control. As a contrast there are no requirements for the ability of the organizations to improve quality or reduce cost.
These different backgrounds result in clearly different requirements for the quality management system. The main concern for a producer of medical products is that the product does not jeopardize the safety of the patient and that one can demonstrate compliancy to all applicable rules and regulations. No surprise the high emphasis on following the rules, good communication with authorities and formally recording all information on the product supplied. On top of this some governments, e.g. North America, employ their own independent inspectors that are entitled to shut down operations in case of (severe) nonconformities.
As a contrast automotive companies demand of their suppliers (and the suppliers of their suppliers, etc.) that they supply such quality that car production is always assured. Hence the strict requirements on controlling the production process and its spreads, fast reaction in case of problems and very detailed requirements for new product introduction.
Now my observation is that, while the two standards mentioned have a completely different background, they have strikingly similar requirements in areas such as dealing with suppliers, control of the measurement system, product traceability and recording of staff training.
For the automotive industry the result is maximum security that materials supplied meet the specification and can be used flawlessly in production. On top of this, in case a defect still occurs, there is the possibility to effectively trace and call back the cars concerned for repair.
For medical products the result is the maximum elimination of risks for the patient and the possibility, in case a problem still occurs, to effectively trace the patients that do run a risk and preventively examine or treat them.
What are the consequences of these severe and sometimes overlapping requirements in practice? At first it is clear that when a company wants to become active in one of these sectors one has to be well aware of the strategic importance of such choice. Suppliers to these sectors have to meet severe requirements and building the ability to do so requires a significant investment. The good news however is that, because of the overlap in requirements, the step to also supply to the other sector (so from automotive to medical and vice versa) is smaller than it seemed at first sight. Especially for suppliers in the high-tech sector that can be good news.