AS9100D Clause 8.5.1.2 Validation and Control of Special Processes

#1
I'm hoping someone can shed some light on the special process requirement. AS9100D clause 8.5.1.2 requires validation and control of special processes. We are a precision machining job shop and we do not perform special processes in house, but we do outsource processes such as anodizing, heat treating, passivation, paint, etc. We do not design anything ourselves; we make product based on customer drawings, specifications, etc.

We send our suppliers a purchase order that specifies the standard/specification that they must follow (which is dictated by the customer). We request a certification to this specification. Is this sufficient to satisfy this requirement?

I've read varying responses to this question- some saying that we have to validate the process ourselves, or audit the supplier, or both. Our aerospace customers that are AS9100 require that special processes be performed by "trained and/or certified persons," but they list no other requirements. AS9100 Clause 8.5.1.2 involves qualification of people, approval of equipment, monitoring the process, etc.

Can anyone help? Thank you.
 
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Sidney Vianna

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#2
We send our suppliers a purchase order that specifies the standard/specification that they must follow (which is dictated by the customer). We request a certification to this specification. Is this sufficient to satisfy this requirement?
In most cases, no, this is not sufficient. You are outsourcing a process that requires validation. In principle, you are responsible to ensure that the processes deployed by your vendors are validated and re-validated, as necessary. Some aspects which could make your life easier are answers to questions such as:

  1. Are the special processors designated by the customer(s)?
  2. Are the specifications dictated by the customer(s)?
  3. Are the special process vendors Nadcap accredited?
  4. Are the suppliers ISO 9001 and/or AS9100 certified with a scope statement that clearly identifies special processes as part of the certification?
 
#3
In answer to the questions:<br>1. The special processors, in almost all cases, are not specified by the customer<br>2. Yes, the specifications are dictated by the customer<br>3. Some, but not all process vendors are NADCAP accredited<br>4. Some, but not all are ISO/AS certified with scope statement<br>
 

Sidney Vianna

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#4
So, first and foremost, you have to require the suppliers to validate and re-validate the processes as per AS9100 8.5.1.2, even though they themselves might not comply with AS9100. Request them to provide you with records of the relevant processes validation records.

For those suppliers which have some form of credible certified QMS, such as a properly accredited ISO 9001/AS9100 and/or Nadcap accreditation, that can be used as a component of assurance that the special processes in question are being performed as per specs and are being validated and re-validated.

For those suppliers which don't have any of that, you will have to devise ways to ensure the processes are properly validated.
 

dsanabria

Quite Involved in Discussions
#5
I'm hoping someone can shed some light on the special process requirement. AS9100D clause 8.5.1.2 requires validation and control of special processes. We are a precision machining job shop and we do not perform special processes in house, but we do outsource processes such as anodizing, heat treating, passivation, paint, etc. We do not design anything ourselves; we make product based on customer drawings, specifications, etc.

We send our suppliers a purchase order that specifies the standard/specification that they must follow (which is dictated by the customer). We request a certification to this specification. Is this sufficient to satisfy this requirement?

I've read varying responses to this question- some saying that we have to validate the process ourselves, or audit the supplier, or both. Our aerospace customers that are AS9100 require that special processes be performed by "trained and/or certified persons," but they list no other requirements. AS9100 Clause 8.5.1.2 involves qualification of people, approval of equipment, monitoring the process, etc.

Can anyone help? Thank you.
The standard 8.5.1.2 list the requirements for a supplier if it is done inside as many facilities have the knowledge and resource to meet those requirements and as auditors we reviewed those requirements.

Second you probably have no clue of what a validated process is because some of them are complex and some are proprietary or directed by customers to use.

What you are asking is for outsourcing such products and that falls into another category which are described in 8.4
 

Eredhel

Quality Manager
#6
We are also a CNC shop. I have always felt like these kinds of sections are referring to things like the inspection of welds and other similar things, including something that requires destructive tests. Especially due to this sentence from the standard, "where the resulting output cannot be verified by subsequent monitoring or measurement". Context below:

"f. the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
NOTE: These processes can be referred to as special processes (see 8.5.1.2)."

And later this:

"For processes where the resulting output cannot be verified by subsequent monitoring or measurement, the organization shall establish arrangements for these processes including, as applicable:"

The list below "as applicable" is organization defined, including criteria and method.
 

dsanabria

Quite Involved in Discussions
#7
We are also a CNC shop. I have always felt like these kinds of sections are referring to things like the inspection of welds and other similar things, including something that requires destructive tests. Especially due to this sentence from the standard, "where the resulting output cannot be verified by subsequent monitoring or measurement". Context below:

"f. the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
NOTE: These processes can be referred to as special processes (see 8.5.1.2)."

And later this:

"For processes where the resulting output cannot be verified by subsequent monitoring or measurement, the organization shall establish arrangements for these processes including, as applicable:"

The list below "as applicable" is organization defined, including criteria and method.
yes! (statement or question)
 

Sidney Vianna

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#8
The standard 8.5.1.2 list the requirements for a supplier if it is done inside as many facilities have the knowledge and resource to meet those requirements and as auditors we reviewed those requirements.
If a machine shop receives an order for a part which requires some special process that is outsourced to a sub tier (special process) supplier, the machine shop is responsible for flowdown of the applicable requirements to the sub-tier supplier, including the requirement for validation of the process.

Outsourcing of a process does not constitute justification for "exclusion" nor non-applicability of requirements. While the machine shop might not have the technical knowledge to ascertain if the outsourced special process has been properly validated or not, they have the contractual responsibility to do so. Another risk to be considered...
 

dsanabria

Quite Involved in Discussions
#9
If a machine shop receives an order for a part which requires some special process that is outsourced to a sub tier (special process) supplier, the machine shop is responsible for flowdown of the applicable requirements to the sub-tier supplier, including the requirement for validation of the process.

Outsourcing of a process does not constitute justification for "exclusion" nor non-applicability of requirements. While the machine shop might not have the technical knowledge to ascertain if the outsourced special process has been properly validated or not, they have the contractual responsibility to do so. Another risk to be considered...
Totally agree - if it is required by the customer - it can not be excluded (inside the shop or another facility) but the requirements that are applicable to be outsourced fall under clause 8.4.
 
#10
Here is an example...we send parts to a supplier for clear anodize per MIL-A-8625. They provide us with a certification to this spec. The certification includes a record of test panels that are sent every 3 weeks to an outside lab for verification that the process is performing per the standard. This supplier is not ISO/AS/Nadcap, but they have a quality management system, training, records of equipment maintenance and calibration, and records of process control. What more would we, as the customer, need to validate or control to meet the requirement?

Our customers only ask of us to send the certification we get from our supplier when we ship the parts.
 
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