The Changing Nature of ISO Special Processes
“Some processes are no longer special and you can relax your controls over these vendors of outsourced special processes.”
The application and implementation of ISO 9001 7.5.2 “special processes” has been and will continue to be debated vigorously. Section 7.5.2 is frequently misunderstood, implemented ineffectively and just plain abused. And certification body auditors do not necessarily understand the requirements any better than the people they are auditing!
Where items produced (or processed) by processes cannot be verified (by measuring or monitoring), then the process itself must be controlled to ensure items are produced consistently and correctly. Verification means checking to make sure the product is correct, and if you cant measure it, or monitor it (compare a characteristic to a reference) in some way then you can’t verify it.
That just makes sense. If you cant measure the product that comes out of the process, then manage the process so the product always comes out right. Clause 7.5.2 lists a number of requirements to make sure that controls are formal and thorough.
Where this activity is performed in-house, those controls can be implemented easily and can be demonstrably effective. However, many organizations have to outsource special process activities. Of course they also outsource non-special process activities: that is, activities that produce or process items that can be measured. If when outsourcing is performed and the items produced (or modified by services) can be verified (measured) when they get back to the organization, then there is no controversy.
Even if we choose not to measure, we still have the ability. Choosing to not measure something is usually based on experience of good measurement results. Thus choosing not to measure does not make a process “special” although the reason that the results are good is that the process is well controlled.
It is only the outsourcing of special processes that causes confusion and which is worthy of further discussion.
Whether a process is in-house or outsourced, you have to be able to demonstrate conformance to ISO or AS for it to be a valid part of your ISO/AS certification. If it’s a special process, then you must be able to demonstrate that the requirements of ISO 9001 Section 7.5.2 are being fully met.
You can do this in several ways although usually they are all initially implemented with purchasing controls. It is your purchase order that spells out the controls you need.
First, if the vendor is ISO 9001 or similar, they are required to have controls in place and you can rely on that certification as.
Second, you could conduct your own audit on the vendor’s processes to demonstrate conformance.
Finally and commonly you can request a certificate of conformance (or similar). This is problematic because it does not demonstrate conformance with 7.5.2 and thus certificates should not be accepted by auditors. It does demonstrate a limited form of control over outsourced processes but may be considered inadequate to demonstrate 7.5.2 for special processes.
To meet 7.5.2 you start, as mentioned above, by having clear contractual requirements. In addition to the product requirements and flowing down any purchasing requirements from your customer, you need to contract the supplier to provided evidence of meeting 7.5.2.
An accredited ISO 9001 certificate should be a good solution because if they have special processes, then they are audited as part of their certification. If they do not have certification or you doubt that it is as reliable as it should be then you should conduct your own audits. In these audits you need to see the 7.5.2 controls that the supplier has implemented. In practice they may be able to provide many of these to you without an audit. Copies of process specifications, work instructions, test instructions, process test results, training requirements and training records, might be among the documentation that could be supplied and should be reviewed to ensure the process is managed appropriately.
All Things Change
Technology has changed. The cost of measurement equipment has dropped substantially and it has provided many special process service providers with access to measuring equipment that makes their processes no longer special – because they can now measure the products. They can measure the result or output of their process. They will still control their processes with enhanced controls but now they can prove it is effective.
These processes are still special to you because you don’t have this measuring equipment and so you still cant measure the items when they are returned from the vendor. However, that vendor can measure the product (not the process) and verify that the product meets specification. Because it is no longer a special process you no longer have to address 7.5.2 controls or have evidence that the vendor has those controls (although they still will) because they are measuring the product.
So if you find that your vendors have obtained this capability, they are no longer special and you want to simplify your control over them then we recommend that you contact your “special process” vendors and get them to verify what measuring capability they have. Ensure you have some tangible evidence of this to show the auditor to back up your justification. This could be a record of a conversation with the vendor, an email, a review of their capability presented on their website, the results of an audit you conducted and/.or you might even want to get a copy of information about their measuring equipment to show the auditor that you have proof the vendor has the capability.
Cavendish Scott, Inc. has been working with ISO for over 25 years and is very passionate about the precise interpretation of the requirements to ensure the ISO 9001/AS9100 quality management system provides a vehicle for discipline, organization and continual improvement, rather than a meaningless, bureaucratic, paperwork system that has to be managed separately from the way you run your business. We provide professional consulting, training and auditing services. Consider having us conduct your internal audits this year.