Many companies have nobly taken on the challenge of obtaining ISO9001:2008 Quality management system - Requirements certification, but in many cases the management system’s tangible connection to the actual product or service of the company is lost.
Why is this so?
All too often the management system is a copy of some other company’s system or is written using the words of the ISO9001 standard with little assimilation to the specific business reality.
Yes, the company has invested money and effort in developing the policy, manual and six mandatory procedures and has had the certification body conduct the review et cetera, all very valuable. However, EON’s experience in conducting supplier capability assessments and supplier surveillances has often found a notable disconnect between the quality management system and the production area of the business; in some cases completely different documentation is used to manage the production activities.
The “golden thread” between the documented management system and the control of the product/service must be tangible. For example, manuals must reference procedures and procedures must link work instructions, forms, and so forth.
The second most notable disconnect is between the actual practices and that which is documented. All too often the descriptions are vague and generic resulting in poor applicability and measurability, and at worst causing hostility towards the management system! The procedure or work instruction (whichever contains the lowest level of detail) must describe the actual activities executed. Typical mistakes are: not providing acceptance criteria, not referencing shop floor documents, not depicting all steps in process flows.
How can these mistakes be addressed?
The “walk-through” approach is a useful tool to ensure that adequate details are described; this approach should be part of the company’s internal audit programme, supporting continuous improvement of the management system.
So, if your documented management system can be used by any company, then it might not be yours!
Look out for future blogs that describe the "golden thread" and "walk-through" approach in more detail, to ensure ownership of your quality system.