Part 1: Whose Quality System Is It?

Whose quality system is it? Who cares and why?

The answer to the first question is, it is your quality system. How do you know it is yours? With no pun intended, the documents probably include your company’s letterhead or logo. And, whether it was developed in-house and prepared by internal staff or whether it was prepared by a consultant, you paid for it. So, it is yours, whether you recognize it or not and whether you like it or not. The answer to the second question is, you care, or you should care, because it is your system.

If the system works well for you and your company, bringing value to the organization, that is a good thing. Assess the system on a routine basis to ensure that it continues to bring value, and look for opportunities for improvement. If the system works, but it is painful to use, it is time to think about change. If you are not sure that you recognize or understand the system, it is time for change. If every system-related action, internal or external, requires the quality manager’s or a consultant’s translation or intervention, it is definitely time for change. You could try incremental change or plan a complete overhaul. Either way, you should not force yourself and your staff to use a broken tool. The tool should serve the company, not the other way around.

If the system needs change, most people will stop and ask themselves, “How did we get into the situation in which we find ourselves?” Analysis is a good thing; that is analysis, not analysis paralysis. There is no need to dwell on the past, but it is important to understand it, so that the past is not repeated. Effort will be required. Change is typically not greeted with enthusiasm, but it should not be feared. Consider the risks and rewards of keeping the current system versus making a change. Change may not be easy, but if it eliminates or reduces the “pain”, then it will be worthwhile. Let’s consider one example of how we might find ourselves in this situation.

Quality systems often become onerous – bigger, more complicated and less recognizable, because changes are driven from outside the organization. Changes are made to address corrective actions or recommendations from registrars (external auditors) and customers. Some of the corrective actions and recommendations may be useful, but others may not be. And, one change layered onto another can ultimately lead to a process description or system that is difficult to understand or fulfill. For example, think about speaking with someone and using the term “rubber band”. The person to whom you are speaking does not know or pretends to not know what “rubber band” means. They are waiting for you to use the term “elastic band”. Have you ever had that happen with a registrar or a customer when reviewing a process description (e.g., document, work instruction) in your quality system?   Your description does not use the exact terminology that the person uses or that is used in the standard to which they are assessing your system. Is your terminology comparable? Is it easy to present it as comparable?

Going forward, does it make more sense to keep your terminology, which makes sense to the staff who use the process description every day, or is it worth the time and effort to revise your description and system to meet the assessment standard? If your organization is a job shop, and your customers employ different standards, can you meet all the standards with the same terminology? The risks and rewards of making changes should be carefully weighed, keeping in mind that actions, no matter how well-intentioned, can have unexpected or unintended consequences. Remember, it is your organization’s quality system, and it should make sense to you and your staff.

Contributed by TDQA Consulting