Posted by Quality Doc
We are committed to our Quality Management system. It was implemented through our decision to adopt ISO 9001 as our basis for a Quality pathway. We have helped maintain our motivation to Quality through annual annual audits since 2004. It has been a very effective approach for us and our customers.
One of our techniques for keeping our system fresh is to introduce variation in our implementation and follow-through. An example is in our approach to Quality Audits.
In our course we talk about four different approaches to Quality Audits:
Internal Audits (IAs) are performed by our own staff to generate information for our own internal purposes including monitoring and improvement.
External Internal Audits (EIAs) are performed by people from outside our program, but under contract. They are performed to generate information for our internal purposes.
External Audits (EAs) are performed by people from outside our program, either people from our certification body or by customers requesting an audit to ensure compliance for their own purposes.
Internal External Audits (IEAs) are often paper challenges or internal inspections requested of us by an authorized agency to comply with regulatory requirements. In these situations we perform the inspection with our own staff and send the agency a completed and signed form. Sometimes the agency may choose to do a follow-up with their own personnel.
This week as we start to prepare for our next certification (EA) audit, we are going through the process of our own internal audit. In the past we have done this by contacting a friend or colleague to come in and do the audit for us (an external-internal). We usually find this has a lot of advantages. EIAs tend to be a little more thorough because we know that there are certain areas that we tend to gloss over because we are confident that they are intact and working properly. EIAs are certainly more objective because outside eyes tend to see things that we don’t.
Depending on who you invite to do these they don’t need to be particularly expensive. If they can drive over rather than come by plane, travel expenses can be kept under control, and if they are a good friend, sometimes you can get it done for a cost of a good meal and a bottle of wine.
As long as you make it clear that you are going through the exercise because you actually are seeking a critical and thoughtful eye, EIAs can be very effective. Make sure that the person you invite is not only a friend a colleague but actually knows and understands your standard and knows what is involved in doing a constructive audit.
This time we are not doing our assessment externally. This year we are going with our own internal audit, I am doing it primarily myself along with our program coordinator. It’s kind of like combining a Top Management Review and an Internal Audit together at the same time.
It’s not so much about saving money as it is about re-engaging. As we have worked through colleagues I was feeling that I was getting more removed from the actual hands-on activity than I really wanted.
I recognize that there is the risk of introducing my own personal bias, but the reality is that with practice and experience that I have had over the years, I am confident that we can be fairly objective in the exercise. In all fairness, I also understand that our regular certification officer is to going to check our work when he comes for our true EA. Any deviation that he detects between what we say on paper in our EIA and we he sees with his own eyes is going to come back and bite me in the neck.
In the meantime this gives me a chance to get back into the laboratory and see on a first hand basis what we are actually doing. And that seems to me to be a good thing.
Overall it is going to take me about 8 to 9 hours over 2 to 3 days.
We will see what we do next time, but for now I am enjoying getting hands-on.
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