As I am working on entering first pass yield data into a system I have created for Valtronic, I am reminded of past businesses that I have worked for. In those positions, the Quality system (or Quality Management System – QMS) was a key identification tool to help businesses and their customers thrive. The QMS systems are THE most important tools for a small or large business to help gage the companies’ health, supplier performance and customer well-being.
The systems in a robust QMS, must take full advantage of the electronic age or fall victim to slow customer resolution times and even slower data gathering. While a paper system satisfies regulatory requirements such as ISO or AS, even those regulatory bodies realize that electronic systems are more widely used and have updated their standards to include verbiage about using electronic systems.
So what are the two items that make a Quality Management system successful?
1. The first system to be deployed (in my opinion), must be the nonconformance system (NCR – Non-Conformance Report). This system is used to record deficiencies in production (or even audits in some cases) which may deviate from drawings, track audit observations and record supplier defects. THIS SYSTEM IS KEY to highlighting internal as well as external nonconformance’s. As an example, I personally have developed nonconformance systems. In my previous life we use to track deficiencies across 72 sites within the organization. As a certified Black Belt, I say that this system is paramount in the QMS arsenal. By using the NCR system, you can easily identify:
- top internal defects
- monitor supplier performance
- monitor technician performance
- gather first pass yield data to trend product lines
… To my point, your NCR system MUST be your most robust system in your QMS! Many folks involved in Quality will disagree and state a CAPA system is most important, however if you don’t have robust data for a correction, then your root cause analysis will most likely suffer.
2. The second major attribute to a effective QMS is finding the way to balance regulatory requirements, customer issues and correcting deficiencies. These are always a challenge but by placing major focus on linking your companies audit program, customer issue resolution and corrective action will bring visibility to everyone in the organization along with action. In my experience, ALL QMS systems must be able to “talk” to each other. For example, when you have good customer issue or audit data, and are trending an issue, the most common reaction is to start a CAR (Corrective Action Report). By having these systems linked to each other, those individuals who are responsible for completing the CAR are able to see exactly which issues drove the requirement for a corrective action. The ability to instantly see the traceability of the issue when it started internally or externally from a supplier (NCR), minimizes the time required to complete the CAR and as a direct result, drives improved root cause determination. This has a lasting effect on driving improved customer satisfaction as well. When customers can see that your QMS systems are tied to each other, and their issue is resolved in a timely manner, it matters.
It is the same for all other QMS systems, having systems linked to each other drives improved Quality response time. Associated systems like audit tracking and notification, training schedules, calibration, documentation control and supplier qualification systems are among some of alternate systems which when linked, provide a truly robust QMS which benefits the business, as well as, the customers it serves.