In Reply to Parent Post by shushd
Thanks you two for your replies. Generally I know all that, what I don't know is when to use it. I'm trying to build up a list of processes in my company, from the time raw materials are coming in, the design phase, prototype, production and try and list the quality methods/methodology/tools we need to use in each of the quality management system stages.
We are very new at this, and wer'e building everything from start. We don't really have a QA manager, and wer'e learning alot as we go along and thanks to this great forum. So, forgive me if it sounds a bit stupid. I hope I managed to clear my self a little bit.
I note from your Profile you declare yourself a "technical writer." I value the work of technical writers in writing clear concise descriptions of existing processes, but I question the value of technical writers being assigned to create the processes from scratch without a strong background in using the tools of the process.
We often see threads started by folks who have been burdened with following a third party quality manual written in generic form by an experienced quality professional, only to find there are procedures and processes included in the manual which are useless and impractical in the thread starter's organization.
One of the most egregious examples I witnessed was a small 5 person organization which had copied the entire Quality Manual and Procedure set from a multi-national corporation with 100,000 employees. Since every employee wore several hats in the small organization, they had the extreme example of the President, who was also the chief engineer and purchasing agent, signing off on new documentation in three places, once for each job title! After I ran a one day seminar for all five employees, they ultimately discarded 90% of their Procedures and reduced the Quality Manual from 250 pages to 30 pages, compliant with ISO 9001:2000. They were able to do the paring of the Procedures and Manual themselves without further input from "experts," (especially not me!)
My bottom line advice:
Sit down with all the folks in your organization and settle these points:
- Can they agree on what the flow of operations are (will be)? This means they can draw a flow chart which lists the order of events in bringing a product or service from initial idea to delivery to the customer.
- Can they agree on who (which individual currently employed) is capable of performing each task in the flow chart and that the person will accept the responsibility and be granted the authority by the others to do so?
When they have agreed on those points, then it might be worthwhile to call in a qualified consultant to help your organization perform a gap analysis comparing the barebones operation with a Business/Quality Management System Standard such as ISO9001:2000 to see where some of the Quality tools might be employed.
That said, some of the tools may be "once and done" or used continually. Take FMEA (Failure Mode & Effects Analysis) - some companies are single product companies and FMEA may only come into play once or twice during the lifetime of the product (during its initial planning and when revisions are made.) Other companies (job shops, contract manufacturers, multi-product companies, etc.) may find FMEA taking up a large amount of time and effort on a daily or weekly basis.
Similarly, SPC (Statistical Process Control) is important for organizations making hundreds, thousands, or millions of identical products, but rarely important for organizations making "one-off" customized products where every customer gets a different product in which most components are purchased from third parties and the organization's primary business is assembling a unique product from standard off-the-shelf third party components.
The point is to fit the tools to the operation, not fit the operation to the tools by imposing nonessential tools.