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Dimitri
I know most of you do quality control work, and my experiance with ISO items is limited so Looking at Wikipedia it lists several things about ISO 9001:2000, my comments are in Red any help understanding this would be greatful.
I'm wondering about this because I may very well end up in a ISO company and if I atleast have some knowlage of the way ISO 9000 series items work then I can atleast understand what is needed to be done without being told if there are problems etc.
Thanks in Advance.
Dimitri
- The quality manual is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality manual is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.
So is stating something like "Our Quality control policy at the company is that each product we sell conforms to the requirements established by the company and the customer to meet the customers need" but the one thing that is confusing is this "Each employee needs measureable objectives", does that include if the employee's objective is to produce parts withing specifications and tolorance and the "measureable" part is counting the number of "scrapped parts" verses the number of "ok'ed" parts ??- Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
Does this mean looking back and checking why parts were not made to proper specifications and that you actually go back and currect the problems ??- You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.
Does a filing cabinet lising manufacturing data like number of parts produced on a specific date and the number of rejections and the reasons why they were rejected meet this requirement ??- To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.
This is means the company needs to provide a few charts on trouble shooting problems for the people working on the shop floor, having someone to relay infromation on why parts are being rejected from QC to the shop floor, a few measuring instruments to the QC people, and have AC and heating ??- You need to map out all key processes in your company; control them by monitoring, measurementand analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.
Mapping out key processes is like saying a product goes from a CNC mill to have "X" things done to it, then goes to heat treating by "Y" method then finally hard part machining/grinding to get to the final product ??- For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required. (Note: a “product” is hardware, software, services, processed materials, or a combination of these.)
Quality objectives are similar to lising specifications and the range the items are allowed to vary without being "defective" ??- You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated.
So this means micrometers etc need to be checked with calibrated gage blocks ?? And if so how do you deal with the fact that different people use micrometers (for example) different, and using the same micrometer measuring the same part there can be a discrepency between the 2 numbers ??- You need to have clear requirements for purchased product. Select suppliers appropriately and check that incoming product meets requirements.
This is the clause which ISO companies are supposed to make their "first choise" suppliers other ISO companies ??- You need to determine the skills required for each job in your company, suitably train employees and evaluate the effectiveness of the training.
Well normally you hire someone who has the skills they require or you hire lets say a apprentice which the entention of them learning as they go along in a shop under a mentor, and the mentor makes the "evaluation" if the new employee is able to preform the job or not. Don't all companies do this anyways ??- You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
So you need to have a customer service department as a requirement if I understand this currectly.- When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.
So pretty much what any R&D department does anyways I belive, you work on something with intended goals to reach to, and you document why doing something failed and why something worked so you don't end up doing the same development job agian because you have no records of what your doing. They just added to the ISO standard.- You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness. (Note: you need a documented procedure for internal audits.)
Internal audits are normally done when too many customers or too many products are not meating spec's and you preform currective action to deal with the problem ??- You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.
So saying this product is out of spec, telling the guy on the shop floor why its wrong and getting the guy on the shop floor to stop doing what he did wrong then dumping the part in the scrap bin is not execptable ??
I'm wondering about this because I may very well end up in a ISO company and if I atleast have some knowlage of the way ISO 9000 series items work then I can atleast understand what is needed to be done without being told if there are problems etc.
Thanks in Advance.
Dimitri