Thanks in advance for your opinions.

My company is a division of a fairly small corporation (about 500 souls) which has been ISO certified for around 10 years. Our parent company is dropping it's ISO certification but my division (84 souls) has decided to pursue independent certification. We are trying to keep everything as streamlined, simple, organic and practical as practicable. We really want our ISO processes to make improvements in both our operations and bottom line.

Because we are so small it will be impossible to field internal auditors who are area independent and, frankly, we never had an internal audit administered by our parent that triggered a meaningful improvement. :nope: We have talked a great deal about claiming process report studies, shipping audits, and the like as audits. Will this fly? If not please share your alternatives.

Check and see if any other local company has someone that can do them for you either as a favor or for a reasonable fee.

Another possibility would be to contact the nearest ASQ chapter and try to get some assistance.

8.2.2 requires internal audits to be at planned intervals, and to determine if the QMS (its processes, procedures, methods, records) conforms to your own plans, to the requirements of ISO 9001, and to any requirements for the QMS you may yourselves have defined. The audits also have to determine if the QMS is effectively implemented and maintained.

To do this internal audits must examine processes - how people work, what they do, whether they follow the processes defined and observe hand-off criteria, whether it all works, etc. Since shipping audits don't examine processes, they won't be acceptable as internal audits. Other audits that look at product also won't be acceptable.

I'm not sure what "process report studies" are. If they're reactive and not "at planned intervals" then again, they won't be acceptable. Nor will they be acceptable if they don't, in aggregate, cover the whole QMS over a reasonable period of time (say six months or a year).

I see no reason why a small outfit can't do internal audits for itself. That the corporate auditors can't find anything useful to report does not mean internal audits don't work, it just means either they weren't looking hard enough, or your operation has evolved to total perfection! (BTW was the ISO 9001 program terminated because auditors weren't finding anything useful?)

To do internal audits yourselves, identify a few people who have the interest and energy to improve your processes. Make sure they're from enough different departments that everyone can audit somewhere else with independence of mind. Work with the management team to give them time out from their regular work to do it - they'll be part time auditors. Have the management team agree to recognise their contribution with public acknowledgement of achievements: that's often enough to motivate them and doesn't cost money. Also have the management team define objectives for internal audits with you, for example, to reduce defect rates, or reduce costs, or position the company for growth with well defined, easily learned processes: that will give the auditors some focus beyond mere compliance.

(If your management say, "But we don't have time for this," tell them that if nobody works on continual improvement, nothing will improve. If they're fine with stagnation, remind them that nobody wins in today's competitive market by being complacent. In other words, being small is no reason not to do this; if everyone is so stretched they can't make time to do it, something is going to break soon anyhow, if it hasn't already.)

Get a decent trainer in to train them - it takes two or three days, plus some hands-on coaching through their first audit. A decent trainer is one who can teach them to listen, and build their confidence to report useful things to the management team.

Not only will this meet the internal audit requirement, it's an excellent way of cashing their knowledge of how their company works, improving morale (by involving people in quality improvement), sharing best practices, and improving inter-departmental understanding and cooperation.

Hope this helps,
Patrick

Also, if your small company has a QA Department they can perform approx. 85% of the internal audits. They just couldn't audit their own work. So you may want to train (which supports Patrick's statement) someone in manufacturing to perform the other, approx 15% that would meet the requirement of the Internal Auditing, in my opinion.

Check and see if any other local company has someone that can do them for you either as a favor or for a reasonable fee.

I perfectly agree with Randy our sister company is in a similar position ( they have ISO 9K ), a collegue and myself do the internal auditing for them, it's been like this for the last 6 years.

Patrick has posted a perfect response, and I must support his conclusions.

You aren't that small. If you were a manufacturer with less than 25 folks then I might recommend hiring a qualified consultant or even a registrar to do the internal audit function. However, in your case, there should be plenty of talent to do the internal auditing.

You might even consider a consultant at first, weaning towards your own staff to support the internal audit function of ISO 9001:2000.

We are trying to keep everything as streamlined, simple, organic and practical as practicable. We really want our ISO processes to make improvements in both our operations and bottom line.

As it should

Because we are so small it will be impossible to field internal auditors who are area independent

Really? 84 people is more than enough to find auditors .... my first system was for a division that had only about 55-60 on-site employees. The standard says objectivity and impartiality...auditors shall not audit THEIR OWN WORK. Not, the auditor cannot audit any work done in his area. If the person can be objective and impartial, s/he can audit. Also, sales people can audit production or maintenance, the receptionist can audit nearly anybody, production can audit maintenance, sales, finance, IT, etc., etc., etc.


and, frankly, we never had an internal audit administered by our parent that triggered a meaningful improvement. :nope: We have talked a great deal about claiming process report studies, shipping audits, and the like as audits. Will this fly? If not please share your alternatives.

And, then again, you can trade audits as suggested above, but you've already discovered that internal audits are done internally for a reason.
I am a big fan of bringing others in to get a fresh look, but who knows more about your business than you? As far as I'm concerned:2cents: , the beauty of internal audits is that they expose employees to areas of the facility that they would otherwise never gain an insight on. You usually get some initial "I don't want to get out of my comfort zone" but that usually gives way to "You know, there really is something to what they've been telling us all this time, we can make changes to make it better for dept. X and that will make Dept. Y more efficient, and then we can sell even more."

Good luck on your division's efforts.

The company I work for has been in business now for 5 years. When we started in 2001, I was the first employee. REALLY. The QA guy was the first employee they hired. I started working on procedures and ISO9001/FDA compliance before we even had a location picked out.

The reason I say this is that for the first 18 months of operation, we were a total of 4 employees. President, Chairman of the Board, QA Manager, and Press Operator. Talk about difficulty in doing internal audits. But we did them. I trained the President as an internal auditor. His audits weren't so "great" at first, but eventually he became a fine auditor.

Now, we're 20 employees strong and the President doesn't "have" to do audits anymore. He does from time to time. Our Purchasing Manager does audits where I cannot.

There are ways . . .

I did registrations at sites with only 50 people and did not have trouble with independent auditors. The advice others have given is appropriate. We included our customer service group which was located in the corporate office as part of the plant registration. It was difficult auditing the customer service group so I did most of it as the division quality manager. On a regular basis, the three plants who used the customer service group took turns auditing the group in general and auditing areas I was responsible for. One of the benefits was having plant people visit the corporate office to audit and see how the work was being done there. If you have multiple sites that are small, it might be useful to let them audit each other occassionally.

Bill Pflanz