Posted By Everette Phillips, April 17, 2014 at 11:34 AM, in Category: The Adaptive Organization
ISO-9000 Quality Management Systems (QMS) can be a very useful tool for capturing and preserving critically important business process as well as laying out a means for future improvement and growth. However, I often come across situations where ISO-9000 QMS actually brings harm to business processes when this need not be the case. This happens when the QMS is not a living document or is impractical. In either case, it is rigid in a way that restricts growth much in the same way that a rigid, too-small pot restricts a plant’s growth.
In my experience, there are often some clear signs when this is happening. The first is that a company is turning away business because adapting the existing QMS is too much of a burden. For example, I have worked with some large machine shops that have turned away business because their QMS did not allow for the easy addition of a new subcontractor needed for a unique plating process. This company had the ability to machine the part and the inspection tools needed to measure all the critical dimensions. But the plating process was not available among their current and approved subcontractors under the existing QMS.
The problem was that this company had allowed the consultant helping them with ISO-9000 certification to create a rigid auditing system for approving new subcontractors. The system included too much detail and too many restrictions. The QMS could have been easily written to allow a process of experimenting or testing a new subcontractor with less overhead and fewer resources. But the way the QMS was written, it required the machine shop created additional costs, making it impractical to take on the new project.
Another sign that a ISO-9000 Quality Management System is not working is when parts in inventory do not match the approved drawings on file. This is a sign that the QMS is so restrictive that employees take short cuts or ignore it. The QMS should reflect the actual workflow of the business and align with it in a way that policing is not required. The QMS should instead be audited, which, while similar to policing, is not the same thing. The main difference between auditing and policing is that policing creates overhead and adds costs, while auditing should help the business and the QMS align and grow together.
There are many ways for parts that do not match drawings on file to end up in stock. The most common scenario is when an experiment is needed. An engineer looking to solve some production issues or help a customer will ask a vendor or internal production team to modify a part. Usually, they take a red marker and “redline” the existing drawing with the change. The QMS process for a drawing change may be too onerous for a simple experiment, so the change occurs outside of the QMS. If the experiment is a success, then the redline drawing may remain outside of document control, because the process to add it to document control is too difficult. And, if the part is received from the vendor under a “dock to stock” arrangement, a change may necessitate a a “required incoming inspection status.” So a discrepancy between parts in inventory and drawings on file results.
Each act outside of the QMS is usually justified as a means to improve customer satisfaction or improve response time or improve yield. It is hard to capture these acts and quantify them. I usually encounter them as we reorganize a supply chain or conduct vendor reduction or cost reduction projects that require matching drawings to inventory parts.
Such signs of a dysfunctional ISO-9000 QMS should be exposed during the audit process. But most audit procedures are not designed to uncover this. For example, rarely do companies take random samples from stock and compare them to current drawing versions as part of their internal audit. However, a good management team will take note of these actions outside of the QMS and look for ways to improve the alignment of the QMS to the needs of the business.
This is a better approach than keeping a rigid QMS in place and policing the adherence of actions to policies that may be bad for business and lead to a “root-bound” corporation.
Written by Everette Phillips
Everette's experience includes robotics, advanced manufacturing, supply chain management and international manufacturing. After a career path as a robotics engineer helping automate plants in North America, he became a manager of European Operations for Factory Automation & Robotics in Europe for SEIKO living an expat in Brussels then returning to the US as GM for Advanced Mfg Technologies in North America. Currently, as President of Global Mfg Network, he is involved in coordinating production of highly engineered parts, assemblies and products across a wide range of industries in manufacturing facilities located in Asia and North America and Europe. Everette is a regular speaker and panelist on topics related to manufacturing, international business and technologies such as robotics and advanced manufacturing. He has a BS Bioengineering from Cornell and an MBA from the UCLA Anderson School. Everette serves on the board of Cornell Engineering Alumni Association as a Regional VP and on the Advisory Board for Entrepreneurship@Cornell.