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Mark Snively, quality control manager at The Champion Co., asked members ofQualityMagazine’sLinkedIn group what quality system software they would recommend if starting a company’s quality manual from scratch. Here were what some members had to say:
Jeff Pfouts, quality assurance at McAfee Tool & Die Inc.: “You might want to define what you have in mind. The size of the company; what resources you have such as IT personnel; computers; networks- what you wish to accomplish and of course the budget.
I personally have not worked with quality systems software, as I have worked at small companies with limited resources and budgets. Our solutions are homegrown with the MS series, though I am not above even going cheaper than that and working with one of the free office suites out there.”
William West, PhD, board of directors at Western Textiles: “You will have to layout your expectations much like any other project. From there you can begin to define what costs you are willing to bear and what the time line is. There are many good systems out there, but without a well defined plan, you may purchase software that looks good but may not meet your expectations later.”
Bob Doering, quality engineering professional; expert in CorrectSPC for Precision Machining: “For a quality manual, I would use MS Word. If you are looking for a canned manual, I really do not have a recommendation for that. For most industries that has been passé”. As far as an overall quality system software, my favorite over all of the ones I have used is still MQ1 from Cebos (Cebos.com)”
Tom Arneson, CQA, president at Focus Consulting LLC: “I would suggest you look at Mike Mickelwright's book,Lean ISO 9000. I have used the suggested two-page quality manual with my last two ISO certification audits. I agree with Bob: stick with the MS products and keep it simple.”
Douglas H. Hoover, principal optical engineer at Reichert, Inc. : “From scratch. The key is to keep it simple (as noted by those posting above). I would recommend contacting a consultant well versed in ISO 9000, 13845 and the entire FDA(Good Manufacturing Procedures (GMP) process. Then I would insist on the absolute minimum page count in a quality manual and reward for brevity and simplicity.
You probably don't want a one-size-fits-all software package. If you want electronic records, a database system and office software (MS or others) should suffice. You can omit quite a lot of the regulatory based requirements for medical devices, but I believe that the basic framework in ISO will be a good choice for a quality management system over the long haul. If you need sophistication over time, it's easy to add, but start with a complicated system and it will haunt you forever. Make sure that any consultant you contact knows that you want a bare bones system and never pay by the page.”
Ken Bunselmeyer, quality director at AG Industries: “ I totally agree with Douglas. Keep it as simple as possible. If you use a consultant, get examples of their documentation. Some just keep piling on more and more documents like band aids. I'd love to see Tom's two-page quality manual.”
Edison Reis, oil sands quality and compliance manager at SGS Canada Inc.: “Mark, you already received several good suggestions, but as mentioned before, keep the quality manual very simple and focus on providing more details on tier two and three documents, procedures and work instructions respectively.
Strive to have a 15--20 page quality manual, which should suffice to give you a good outline about what does your company do and who the company is. Everything else can be addressed on tier two and three docs.
Michael McMonagle, quality manager at OYO Geospace: “I'm in agreement with Tom. Take a look at Micklewright's book on lean ISO. It's a radical approach that makes perfect sense once you digest it. I recently attended an ASQ seminar with Mike, and we are now looking to use his approach in our revamping of our existing QMS and Tier two procedures.
The ASQ Web site has a short one hour webinar with Mike discussing Lean ISO, and his book (hard copy or ebook) is available at a discount to ASQ members.”
Ronald Barr, vice president of quality at Transphorm: “[It] definitely depends on the size of the company, and if you are going to ISO9001 or something else, [and] your budget.
I am currently working on my second "greenfield" ISO9001 implementation, and have also done a greenfield 14001, and so share your pain. I've used template files in the past as a starting point. You might Jack Kanholm's book and his materials. A simple database program to help to track your QMS can be very helpful, and is better than using spreadsheets. I started our ISO program using ISOxpress and their materials to get things going (this is also published by Kanholm) They have the templates and their program is pretty good. It's been updated since I used it last about a year ago.
Later we migrated to an integrated system, EtQ and expect to go for registration in the near future using it as the platform for our QMS. A fully-integrated system requires some upfront costs but is much easier to deal with in the long run. [It] depends on your requirements and resources.
Consultants are a two-edged sword. You can turn the entire program over to a consultant, but then need to make sure that the consultant's system is going to fit your company's needs, culture and budget. My own approach has been to generate the system as best as I can and then use consultants to audit, critique, and as general sounding board to bounce ideas off of. I then plan on a couple of internal audits to work out the bugs before going for registration. As long as you are OK with your consultant telling you that your work isn't worth spit and working with them to fix it, this is the way to go. At least it has worked for me the last two times, and seems to be working on my third.”
Stephen Cummings, high-tech sales and marketing executive: “It sounds like your company is just starting out with quality and is still small. Another approach for starting out quickly but with a good foundation for the longer term is to look into a commercially available online solution. This would get you more than just the quality manual, but you'll need more soon enough. A hosted solution means you can start with a few users; not worry about having to run a server yourself; and capture the benefits of a structured and integrated, computer-based QMS. As a vendor, I help companies deal with this issue all the time. But I'd recommend you consider this approach, even if you don't go with us!”
Willy Grunfeld, owner and principal consultant at TQAS, quality manager at Shafir Production Systems: “I suppose you mean QMS support software, and if that is the case, it has very little relationship with the status of the quality manual.
“The most important feature to look at in a QMS support software is what effort does it take to integrate it with other company-wide software like ERP, CRM, PDM, etc. The best software is worthless if it doesn't exchange data with these other programs. As for writing/maintaining the quality manual and quality procedures, I agree that MS Office or equivalent is all that's needed. In a very large company with over 20-30 procedures, a document management system would make life easier.”