First, what are those ‘good manufacturing practices’?
Think of it as the requirements of ISO 9001 (which are vague enough to be applicable in any type of organization) + some specific manufacturing arrangements.
- For general consumer goods, GMPs include batch-level traceability, identification of all materials, audits of processes and systems as well as corrective actions, 5S, and so on. This is generally what companies like Costco check in their GMP audit forms. It is ‘ISO 9001+’.
- For automotive parts, it goes into new product introduction, measurement system analysis, statistical process controls, and so on. In that case, it is inspired by the IATF 16949 standard (which goes much further than ISO 9001).
- For medical devices, some elements such as traceability records and the plan cleanliness are given more importance. It is close to ISO 13485 (which also goes further than ISO 9001).
- For food production, it is all about personal hygiene, facility hygiene, and premise hygiene. These requirements are part of ISO 22000.
- I could go on and on: pharmaceuticals, cosmetics, etc.
Does it even make sense to audit a factory based on a GMP checklist?
If you really, really can’t afford to work with a manufacturer that has little control over their processes, it does make sense. In other words, it helps with risk evaluation, in your supplier selection process.
If you can afford to buy product from a bad supplier, catch the issues, and over time switch to another supplier, it doesn’t make much sense. A typical quality system audit will be plenty.
Does a GMP audit drive improvement?
In the short term, some serious lapses in the factory’s systems might be detected, and it can only help. (Note that, in many cases, this would also be caught by a traditional, ISO 9001-style quality audit.)
However, in the mid-to-long-run, it is not likely to help. I have visited factories that have had 5 annual GMP audits (by the same customer) in a row and haven’t improved one bit!
Michel Baudin commented about maturity assessments in general:
The reason this approach is popular, particularly with the supplier support groups of large companies, is that it doesn’t require the auditors to know any specifics of the business, management, and technology of the organization they are scoring. They can see whether all the visible signs of 5S are in place, each team has a performance board and each machine an andon light,… You can even check how many Kaizen events they have run in the past 12 months.
The suppliers learn how they must appear to humor the auditors and engineer their facilities to look right. To them, it’s a cost of doing business, not an opportunity to improve, which explains why they don’t perform any better than competitors. If instead of complying with external mandates, an organization is driven by its management to improve its practices at all times, in pursuit of broader goals than certification by a customer, it will not follow a generic script and perhaps undertake projects that are not as spectacular to auditors but are more useful.
Very true… Repeated audits often train the supplier to play games.
David Collins wrote about this in Are Your Production Management Systems For Real (Or Just For Show)?:
I recently visited a factory on behalf of a client. They wanted me to see if the factory was capable of making the products that the company needed at the right cost and quality. When I called the supplier for an appointment, the representative asked me what standard I wanted to see: ISO or something else?
I told them I wanted to see their production systems and how the factory knew that the people were doing their work properly. I also asked about maintenance, incoming quality control, and how they developed their new products.
The representative in charge of sales asked me what I meant. I said, “Well, do you have FMEA’s, a preventative maintenance system for machines, the standard work instructions for the operators, etc.?”
She was very polite and told me those things were no problem. She asked if I could send her what I wanted to see and she would have this all filled out for me by the time I came the next week. I said do not worry about it – I will just see her.
What I found, of course, is that the factory had little documentation that was relevant to its actual processes and procedures. It was ISO 9000 certified and had mountains of irrelevant paperwork that had nothing to do with its actual processes.
Do you agree? Have you seen some factories improve on their own, simply on the basis of a good manufacturing practices audit?
You may also enjoy our podcast episode about GMPS which you can listen to here:
We are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. QualityInspection.org does not present this information as a basis for you to make decisions, and we do not accept any liability if you do so.
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