Two months ago I started working for a company in the rubber industry. The quality department consists of myself and my supervisor. They have been toying around with the idea of ISO for a few years now I am told but never had anyone on staff with any kind of experience. This is where I enter the picture. Basically I have been given 6 months to come up with a rough draft quality manual that will convince the executives to invest the money for certification. The problem I am having is in trying to locate sample quality manuals for ISO 9000 and ISO 17025. If any one out there can help with this, or offer any advice, I would greatly appreciate it.
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guest 3/30/2005
Recommend you go with green for quality - green means go, or money.
Augment with the following colors for other conditions
Yellow - potential problems, nothing bad yet, but look out.
Orange - CA required or measure will fall below standard
Red - out of control, below standard, nonconforming, etc.
Purple (bruised) - does not meet expectations, but CA has begun and things are headed in the right direction.
Blue - meets minimum requirements, headed in the right direction. Bruises are starting to heal.
And, back to green when things are OK.
Alternatively, consider arrows
Up arrow - good (thumbs up)
Left - backsliding or regression to bad practices, potential problems are brewing
Down - needs improvement, now.
Right arrow - not optimal, but improving
On a related note, anything that uses commmon cultural archetypes will work - smileys/yucks, weather symbols, and so on. The important idea that you have correctly seized upoon is that the CEO (or other outsider who knows nothing about the area) should be able at a glance to answer the question, "How are we doing?"
Bill
guest 3/22/2005
We use green to show when we are operating/reached our target area.
guest 3/22/2005
Green
guest 3/15/2005
The questions you ask come from 2 sources. The first source is the standard and questions from the standard that apply to this operation. The second sources are from the documentation that defines how the work is to be accomplished. The essence of ISO 9000 is document what you do and how you do it, then do what you say. The audit is to confirm conformance to your operating procedures.
guest 3/15/2005
Obtain the requirements ISO 9001:2000, and internal Company Procedures or work instructions, engineering drawings, customer Specs. Do this ahead of time. Read and formulate your own customized checklist. It will be more effective.
Good Luck. Buy Chad Kymal's book: 'How to Audit ISO 9001:200' from Paton Press. Great for developing audit trails.
Richard Flutie
rflutie@drs-ts.com
321.727.3672 X 3080
guest 2/11/2005
I have the same question. Is it possible to get the questionnaire listing?
guest 2/9/2005
If you do signup for a beginners internal auditor course, and I hope you do, you will learn how to read the company's Quality Manual and procedures to identify "action" statements. These action statements typically state "who" is to perform "what" task, "when" the task is to be performed, "where" the records of this task being performed will be retained and "how" long the records are to be retained.
You should be able to take these action statements and create your checklist by turning the statements into questions.
For Example: This statement could result in the following checklist questions. "The Quality Manager performs the internal audits as stated on the Internal Audit Schedule and places her initials and the date of completion in the space provided on the schedule when completed. The Quality Manager retains the audit report, the audit checklists and supporting documentation, and a copy of each Corrective Action Report generated during this audit in the Process Audit notebook for three years."
Typical internal audit checklist questions might look like this:
- Does the Quality Manager perform the internal audits as specified on the Internal Audit Schedule?
- Does the Quality Manager place his/her initials and the date of completion in the space provided on the schedule to show completion?
- Does the Quality Manager retain the following in the Process Audit notebook: the audit report, the completed audit checklist and its supporting evidence, and a copy of each Corrective Action Report that was generated as a result of this audit?
- Is there evidence that the audit records are retained for three years as required by the Quality Manual?
Hopefully this will help get you on the right track.
guest 2/8/2005
A good starting point that I would suggest is AS9101B (soon to be Rev. C). This is more in-depth than straight ISO9001:2000, but is very detailed and in my experience, invaluable as a audit checklist basis. Cost is $125 for Hard Copy, $250 for Electronic Download (MS Word format). There is a 20% discount for SAE members.
guest 2/8/2005
Starting out by learning from a checklist if a good start. By not re-inventing the wheel you save time on start-up with the goal of enhancing the checklist to fit your organization. Smart idea. I would be happy to send you a copy of our's. Does this forum allow for email id's to be posted, if so, let me know where to the checklist.
kevrac 2/7/2005
I don't think a generic checklist will be of much help. Usually an internal audit checklist is just that, a checklist composed of questions as they relate to the individual company's quality manual and procedures which are typically unique to your company. As the previous person suggested, you may want to take a beginners course for auditing, there are several good ones to choose from. Do a search online and inquire about some of the classes offered. Also looking at some of the generic checklists may help you in understanding the basic types of questions to ask, but be careful, they're not all good. Good luck.
guest 2/7/2005
Amazon.com has some ISO checklists that you can buy, but they're kind of pricey. You might also try getting into some kind of introduction to ISO auditing class. That way you can find out how to audit, and how you will be audited. They usually provide some good material for you to take home, too. For the most part, though, I think they have discouraged the use of checklists for auditing anymore. They seem to have moved away from an "elements" approach and more toward a "process" approach. You might also try the ISO website at www.ISO.org
guest 2/7/2005
You know, people like you are the reason this country is in the bad place it is! Do the work yourself you idiot!!! If you think there is a shortcut, think again, and if anyone gives this fool a checklist, shame on you! It's all about getting it done fast and easy, you don't really care about quality, you just want the certificate to open up the sales opportunities! If we all took pride in what WE DO OURSELVES, maybe the quality of our products would change! We all need to wake up people! We in the United States make CRAP! Be insulted if you want, but it's the truth. I am stuck with a bunch of it in my house right now! Two Maytag machines (washer and dryer) that break more than they work, a GE refrigerator that constantly breaks, a GE washer that stopped working two days after the warranty period, and GE wouldn't do a thing to help me, now that is Customer service, where's your customer survey on that! I can't keep a vacuum cleaner working for more six months without it breaking, cars that rattle and literally fall apart, and hundreds of small items that just can't, don't or have stopped doing what they are supposed to. We do FMEA's, so we'll know just when to cut off the warranty, we do Lean to cut our expenses at the cost of our Customer's satisfaction and product quality, we do SPC to keep our products at acceptable quality levels, what about the fallout! We lay off our workers because the economy is bad, why do you think it is bad! I have absolutely no confidence in American products anymoe, and it breaks my heart to say that, because I believed in us. Oh, and if you think I am just blowing off steam and do not know what I am talking about, you're wrong. I am a Quality Manager for a very large company, who I will admit is as guilty as the rest when it comes to quality, it is a sale tool, and it makes me sick! WAKE UP AMERICA, WE'RE DYING HERE!
guest 4/5/2005
Angry Person:
Do you believe in preventive maintanace? Thigs can breakdown after certain period if you do not take care of it. Not a single things runs for ever without needed preventative care. If you can not do it yourself or do not spend money when needed or follow the manual thats what happen. I will tell you that I have to open vacum cleaner once a month to clean hair that pluged up roller and eventually burn the belt. I do not believe thats vacum cleaner manufacturer falts it is condition created in carpet. Do you clean your washer, dryer, refrigerator on regular basis for dust? I agree with one thing that GE product are not quality product but when you buy it for what ever reason you should have thought about it. You can not resolve the issue unless you write to GE.
guest 4/5/2005
Yes, I firmly believe in preventive maintenance, I have two vehicles with well over 200,000 miles due to my comitment to it. The appliances in question broke within the first year, all of them. I have contacted the companies and have had some level of satisfaction, but still have unresolved issues. These companies have fallen short and do not reply to my requests, I believe in hope that the warranty period will pass. I do maintain what I own, unfortunately, this is not why there have been failures. I am glad to see that you understand the importance on PM and have the ability to open your vacuum, I am truly impressed. The next time you want to try to attack someone on a subject know the facts, do not assume you know the answer without truly knowing. Yet another reason companies wind up in the gutter. People like you change things that you "think" are the problem. Maybe you should take the time to learn about "fact based decision making". Never make a decision based on perception. Make sure you always take time to collect and analize the data so you do not make a fool of youself and waste your company's time and money. I hope I have "cleared the air" with you.
signed,
aparently more skilled than you
guest 3/22/2005
A check list does not necessarily mean that he was or is looking for a "short-cut". Had it ever occured to you (angry person) that he is new to the standards and that this list may help him better understand how to navigate throught the standards in order to fully implement this in his procedures? Further more, if you own "crap" from GE and other companies why should he have to eat what you "crap" out? You sound like a very angry person that is closed minded and angry at your profession, so my advise to you is, why don't you go work for GE and help them not to make and sell "crap" as you so bluntly put it.
I am glad I do not work for you, smile.
Signed
Not a angry person, Happy person.
guest 4/5/2005
I'll answer your messages separately. Yes, it had occurred to me that this person was new to the standards, even more reason for him to go through the learning process for his and his company's benefit. If you start out short cutting everything, you'll never learn the systems in-depth. I didn't mean to single out GE, but that is how you have taken it. In general my statement was aimed at American businesses in general. Yes, I am angry because I've been victimized by these companies by believing I was getting a "Quality" product and wound up with crap. I am very open minded and love my profession, which is why I get so passionate when big business tarnishes my profession at the cost of me and you, the cutomers. If anything, the companies are the ones who are closed minded, they will never hire me and let me fix the problems because I do not posess a degree. I am very successful in my area of expertise, but because of the closed minded people who hire only "degreed professionals", there is no chance for someone like me to make a difference.
guest 3/7/2005
I absolutly agree with the gentleman whos belongings are literally falling apart. I am a QE in asia, and we have to report to the procurement organization, ppl there cant differentiate QA from QC. Everthing is done mostly for show, for speed for money.
You'll be surprised all those Cpk data submitted for each lot to all the disc drive makers here..!!!?? its a big joke..
Just like this idiot who is looking for a "checklist" to audit...the QMS is there for you to read, you have to go thru and verify compliance. Doesnt the QMS serve as a checklist?