SBS - The Best Value in QMS software

Validation Of Outsourced Special Processes under AS9100

Steve Weber

Starting to get Involved
#1
We outsource special processes such as plating (chrome, Type I, II, & III anodize, nickle, etc.) What can we do to meet the standard requirements for validation AS7.5.2? Our auditor suggested purchasing a hand-held instrument to check the thickness ourselves and see if that meets the sspec requirements. We need something to satisfy the AS requirement and not a method that might create conflict with the vendor suppling the work.
 
Elsmar Forum Sponsor
W

world quality

#2
Re: Validation Of Outsourced Special Processes

Steve,

See if your customer will accept this and have your supplier quality do a audit
and implement it and its requirements. Only the requirements that pretain to your process.

I would agree you need a elcometer or something to check and evrify the thickness.

If you need one for paint I can give you that to.
look under painting and plating for supplier quality here on the form and
download them (CQI-11 CQI-12)
 
J

Jeff Frost

#3
Re: Validation Of Outsourced Special Processes

Steve,

I am assuming that you are saying AS9100 Clause 7.5.2 (It helps to tell us here at the cove which standard). It sound like your registrar is a little of his or her mark. Clause 7.5.2 with its aerospace adders relates to your special processes, not your suppliers.

Your suppliers are controlled through purchasing process 7.4.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Re: Validation Of Outsourced Special Processes

But if you outsource a special process, you are still responsible to ensure it is validated. Obviously a thickness check is not adequate. That would defeat the definition of a special process that needs to be validated.

To what specs are these special processes supposed to be performed against? Many times, those specs define how the process gets validated.

One alternative (albeit costly) is for you to use NADCAP accredited suppliers for those processes.
 

Steve Weber

Starting to get Involved
#5
Re: Validation Of Outsourced Special Processes

Thanks Jeff, I'm new to this an appreciate your help. You are correct. The nonconformity deals with AS 7.5.2 (Validation Process)stating there is no objective evidence that company is requesting and keeping outsourced process records. We have a C of C but was informed that that was not the same as validation. How do we know that what they say they are doing is really being done?. I guess we did not know how to answer the auditor in a logical manner.
 
J

Jeff Frost

#6
Re: Validation Of Outsourced Special Processes

Steve

Sidney is correct. Easiest way to handle this is to 1) perform a process audit at the supplier to the requirements of the specification. 2) Use OEM approved special processors (specified via PO), 3) Use NADCAP approved processors or 4) send a sample of the plated part to an independent lab and have it validated per the specification.

Look at the requirements of 7.4.3 of the AS9100 standard. If the plating is not considered a Key Characteristic or Critical to Flight Safety application then of one of the aerospace additional requirements listed plus a thickness and adhesion test may be only be required.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#7
Re: Validation Of Outsourced Special Processes

Steve/All,

We might be confusing Validation with Verification. Interestingly, the registrar suggested a verification activity in order to satisfy a validation requirement. Purchasing the handheld device will probably satisfy two needs: 1) satisfying the registrar by fulfilling an expectation, 2) having the device available for the validation you will still need to perform (unless the supplier has one already, which they probably do).

Assuming that the AS requirement for validation of special processes is similar to the requirement in the medical device industry, the aim here is to qualify/validate the special process where 100% verification of an attribute would not be effective. Plating sounds like one to me. Investigate whether or not the plater has the ability to perform a process validation. If not, does your organization have the ability. If not, hiring a consultant to perform the validation for you might be the way to go.

What you will need to provide the registrar with is a summary report confirming that the process is capable and repeatable in delivering you product that meets specifications every time. The higher the degree of confidence you achieve, the less the need to do inspection from that supplier.

Back to the group…

Regards,

Kevin
 

Big Jim

Super Moderator
#8
Re: Validation Of Outsourced Special Processes

Lets look at portions of 7.4.3 from AS9100B.

"Verification activities may include a) obtaining objective evidence of the quality of the product from suppliers (e.g., accompanying documentation, certicate of conformity, test reports, statistical records, process control)"

"b) inspection and audit at supplier's premises,"

"d) inspection of products upon receipt,"

"Where the organization utilizes test reposts to verify purchased product, the data in those reports shall be acceptable per applicable specification. The organization shall periodically validate test reports for raw material."

I hope I caught the pertinent portions here.

I wonder if they are suggesting periodic test reports? A common practice for this is to randomly select test reports to send samples (coupons) out for an independent lab to test and compare with the certs the supplier furnished. What I often see is something sent out every three to six months.
 
A

andygr

#9
Re: Validation Of Outsourced Special Processes

Since you are operating under the AS system this indicates that you are in the aerospace food chain. This being the case more and more the Nadcap requirement is being officially passed down the food chain ( Goodrich Corporation just issued the mandate letter for all suppliers and subtier suppliers to be Nadcap approved ).
Selecting a supplier that has been thru the Nadcap review gives you evidence of a review of their special process by a third party qualified individual and meet element a of 7.5.2.. While you may not have visibility to the audit details on line at eauditnet you can always ask that they send you the certificate that is issued.

If there is no need for Nadcap then they are still required to work to some process specifications and for the process that you listed plating (chrome, Type I, II, & III anodize, nickle, the applicable specs most likely define the solution control , periodic process panel and qualification that are required. I would use these records to show evidence of review of the process to cover elements a,b,c,d since it clearly states “as applicable”

The element e for revalidation also as applicable and if not required by spec or your own internal procedure in some way you would not be required to do anything.
:2cents:
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#10
Folks,

Let's keep in mind that verification and validation are not the same. Certs of Conformance and inspection on plating thickness (verification activity)will not suffice (but might if the auditor is weak).

For instance, an inspector makes a measurement of plating thickness and finds that it meets PRODUCT specifications. Have the PROCESS specifications been maintained through the plating of the part? How would you know? Will the part flake due to poor surface preparation? Is plating thickness the same uniformaly especially in corners? What is the suppliers Preventive Maintenance program and how well do they monitor/maintain equipment, solutions in tanks, etc.? (I’ve emphasized PRODUCT and PROCESS to draw distinctions and not to shout at anyone)

Special Processes are those processes which inspection and test alone are insufficient to determine the acceptability of a part/good. It is necessary to understand how well designed a process is at meeting the design requirements of the part/component. Consider the inputs to producing a finished part/component/good: man, machine & equipment, material, methods, measures and environment. Validation examines the robustness of each of these areas in meeting the PROCESS specifications. Invariably, some means of test and inspection will need to be performed to confirm the process capability at meeting the PRODUCT specifications. Often times the inspection and test methods themselves are Special Processes requiring their own verification and VALIDATION. Validation challenges that the process designed to manufacture (plate) a good consistently produces product meeting PRODUCT specifications.

Keep in mind that verification and validation are both necessary. I’d like to also offer that Statistical Process Control is also a critical element in assuring product quality and conformity. SPC more so than SQC, perhaps, but both are important.

Good discussion folks! Back to the group…

Regards,

Kevin
 
Thread starter Similar threads Forum Replies Date
T Outsourced Manufacturing - Do we or our manufacturer has to perform the validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
R Validation of outsourced processes - Calibration - How do we validate that? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L Validation without Tolerance Qualification and Validation (including 21 CFR Part 11) 0
shimonv Test Method Validation ISO 13485:2016 - Medical Device Quality Management Systems 6
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Melissa Process Validation of Rotary Heat Sealer Speeds Design and Development of Products and Processes 4
C Validation of process for releasing the UDI EU Medical Device Regulations 4
C Validation of process for production and servicing 5.7.1.5 API Spec Q1, 9th Edition Oil and Gas Industry Standards and Regulations 3
W Transport validation Qualification and Validation (including 21 CFR Part 11) 4
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 6
C 8.3.4 Verification and Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
W Transport validation Qualification and Validation (including 21 CFR Part 11) 12
mustomutlu Process Validation Final Report Other Medical Device and Orthopedic Related Topics 2
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 8
C Spreadsheet Validation and Release Qualification and Validation (including 21 CFR Part 11) 2
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
M Sterile packing validation tests to be performed and protocol Other Medical Device and Orthopedic Related Topics 1
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 1
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
C ISO 19227 Validation Cost Other Medical Device Related Standards 2
A CNC Mill and Lathe - Validation Manufacturing and Related Processes 2
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
W LTPD, AQL, Ppk and Cpk validation sampling plan table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
J Validation Sample Size for Tray Seal Qualification and Validation (including 21 CFR Part 11) 3
F AS9100 - Validation, FAIR's, ITAR and Sub-Contracting AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
B Sterilization Validation Plan Other Medical Device Related Standards 3
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
T Laboratory Verification after validation ISO 17025 related Discussions 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 10
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
B TMV - Selection of TM's for Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 4

Similar threads

Top Bottom