So, what is the natural reaction of many suppliers after a few audits that have effectively eliminated their chances of selling to prospective customers? They opt for the quickest and most straightforward solution. They work with a consultant who sells them a package of services that includes a set of documents, some instruction on how to answer questions, some guidance on how and where to show records, and some assistance in selecting an accommodating certifying body.
The auditee can demonstrate that they have a standard operating procedure (SOP) for every requirement of ISO 9001 (or 13485, or whatever standard they claim to be in compliance with)
Ticking boxes is simple — they have such a standard operating procedure, such a policy, and so on
But where have all of their nonconforming material reports disappeared to
Where have all of the customer complaints gone
Is it true that everything is running perfectly
Once an auditor has determined that this is the way the game is played, he or she can ask questions and observe actual practices, and it is usually fairly simple to identify inconsistencies in the game
See 10 Signs of a Poor ISO 9001 Implementation for more information
Those suppliers are taking advantage of you. They put on the appearance of having a well-tuned system, but they never use it. You must examine their processes in detail, as well as the actual control points they have established, and if possible, their overall organizational culture. A typical Pre-Shipment Inspection management system audit is not a good fit in this situation. Yes, that is correct. Inquire about their manual as well as some of the standard operating procedures. It will have a 'boilerplate' appearance. Choose a specific aspect of the manufacturing or testing process that is clearly critical to quality, and ask for the documentation pertaining to that aspect. You will receive nothing that is tailored to the specific process.
Some suppliers 'get it,' while others do not. They are aware that the costs of poor quality outweigh the costs of taking preventative measures in the first place. They are well aware that they must put in the necessary effort to put in place a good quality inspection services management system and keep it up to date over time. Perhaps a key customer gently nudged them in that direction, or perhaps a superb quality manager has been at the helm for several years.
When the Production Monitoring Service management system (QMS) is properly implemented, it is like a beautiful symphony. Detailed procedures and other key documents have been developed in accordance with the processes. Extra points are awarded if they employ what we refer to as the "three basic process improvement tools" (flow chart, fault tree, and control plan), as this makes the auditor's job easier and demonstrates a genuine desire to do a good job. The danger is that you will not continue to look for inconsistencies and lapses. For example, the auditor may fail to take some examples and may dig too deeply into the details in other instances. Every living system has... let's say 'imperfections,' as the saying goes.
They may, on the other hand, be picky about the clients with whom they choose to work. It is possible that they are already extremely busy with their current customers. Check to see if they are interested in doing business with you. With certainty, their QMS documents will not be 'boilerplate,' and they will go into greater detail. Consider the following scenario: a supplier is designated as "type 3," and the CMM Inspection Companies manager who was responsible for keeping the entire system running leaves. Top management recognizes that their success is due in part to the excellent system, and as a result, someone else is tasked with ensuring that it continues to operate. However, that'someone else' doesn't do a particularly good job.
Quality Assurance (QA) vs. Quality Control (QC)
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