Rob Kantner answers your questions:
Inspection: always documented? (8/25/08)
Incoming inspection of purchased items is not always documented. We have found that if deliveries are made during breaks or lunch hour, the required inspection tickets are not completed. I'm told that the inspections are actually done, just not documented. Is this a problem?
Uh, yes. Problem 1 is 9001 compliance. The Standard requires documentation of inspection. Problem 2 is consistency. From what you say, incoming inspection is documented at all times EXCEPT during breaks and lunch. If the control is important to have at non-lunch and break times, then it's important to have during those times also. The inspection ticket proves that inspection was done. If the inspection is not documented, it may as well never have occurred. Perhaps the inspection ticket itself is burdensome; if so, simplify it. But it must be used every time. (Side note: It amuses me that people would actually justify noncompliance with the system because they happen to be "on break.")
What Standard should vendors be registered to? (10/11/04)
What are the ISO certification that you should look for from outside sources? For example we have one that says in accordance with ISO 9002 & ISO-IEC 17025.
ISO 9002 is no longer a valid or operative standard and has not been since 2003. In quality management, the prevailing quality standard to expect people to be registered to is ISO 9001 (2000). The prevailing environmental standard is ISO 14001 (1996).
ISO-IEC 17025 is the standard for testing and calibration labs, so my guess is that the outfit you're referring to is in the calibration business. If you're concerned about their ISO 9000 registration, ask to see their certificate. If they were ISO 9002, by now they should have transitioned to ISO 9001 (2000).
What sub-contractors must we control?
The Standard requires control, development and performance tracking of your sub-contractors. Which subcontractors do I involve here? Is it okay to involve only those subcontractors who supply process material that eventually get incorporated into our final product, or is it more then just this?
The subcontractors (vendors) you must control are all those whose products and services impact the quality of your output. So it's not just raw material. It's also maintenance equipment, parts, and services, transportation services, temporary help services, calibration services, your ISO 9000 consultant (if any), your ISO 9000 registrar (when you recruit one). You get the idea.
Excluded are suppliers of such things like paper clips and copy paper (unless, of course, you're in the business of selling those things).
The amount of control you exert over these vendors depends on the extent of the impact they have on the quality of your output.So a lot of judgment comes into play here (and is entirely permissible under the Standard).
Vendor Appraisal
Why is vendor appraisal an essential activity?
Vendor appraisal is important because so many organizations are highly dependent on the quality of products/services provided to them by vendors. The expression "garbage in, garbage out" applies here. High quality, efficient vendors provide products/services that are dependable, that you don't have to modify, adjust, or correct before using them. Lower quality vendors force you to spend your own time, money, and other resources fixing THEIR mistakes before their products/services are useful. It's especially important to have a solid selection/control process for vendors of CRITICAL products/services (those that have a direct, strong effect on your customers and/or the products/services you provide to them).
