Qualification Builds & Process Changes (AS9102 - First Article Inspection)

S

SiMoore

#1
I am looking for advice here as my experience within Qualification Builds is limited.

I have a Customer who has now informed me that the products we are making for them are for Qualification rather than Development and my take on this means that all the processes we use must be authorised and be in line with what we aim to do in Batch Production.

The question

The Customer has authorised multiple processes in their specification and we want to use 1 of 2 methods.

If we use Method 1 for the NPI and state this in the FULL AS9102 we provide. Are we allowed to change to Method 2 once we go into batch as long as we do a PARTIAL AS9102?

Or does it mean the Customer has to get the part re-qualified?

To me; as the Customer has already authorised the 2 methods, and that we should be able to change between the two methods as and when the quantities dictate as long as we have the Full and Partial AS9102s completed showing the difference in the Processes.

Or should we run this by the Customer and get their take before selecting our process?

Thanks
 
Elsmar Forum Sponsor

PenutButer

Starting to get Involved
#2
That is typically going to be customer to customer as far as a full approval or a delta.

As far as the spec is concerned you will need to do a delta FAI for anything the change may have impacted. We do these when we move a part from a mill to a lathe or OSM or vice versa. Some of our customers only want us to perform the delta and maintain it, while others want to have a full source inspection any time we make a change. We have some controlled planning where the customer makes us get reapproved if we move the job from the actual mill it was planned on.

Your customer should have some blurb in their Supplier Quality Requirements about work transfer that will lay it out for you. If not, I would suggest getting a hold of the customer supplier quality rep and ask them.
 
Thread starter Similar threads Forum Replies Date
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
Y Examples of TRB Reports for MIL-PRF-31032 Qualification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
T Qualification testing of Lead acid batteries Reliability Analysis - Predictions, Testing and Standards 0
Z Qualification of AzureDevOps in Gxp Qualification and Validation (including 21 CFR Part 11) 12
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 3
B VDA 6.3 Qualification as Process Auditor training course and exam VDA Standards - Germany's Automotive Standards 0
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
H How to prepare Performance Qualification (PQ) for autoclave General Measurement Device and Calibration Topics 2
D ISO 13485 - Equipment validation , qualification Qualification and Validation (including 21 CFR Part 11) 6
DuncanGibbons Qualification vs Certification in an Aerospace context AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Z Operational Qualification for Injection Molding Supplier Quality Assurance and other Supplier Issues 6
S AIAG CQI Auditor Qualification and 3rd Party Certification Requirements General Auditing Discussions 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
R Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 3
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
Z Training Qualification Matrix for ISO 9001:2015 Audit General Auditing Discussions 8
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
I Compressed air system qualification and 1 micron particle analysis Other Medical Device Regulations World-Wide 0
S Medical Device Supplier Component Qualification Service Industry Specific Topics 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
K Is Mold qualification / process validation always required? Manufacturing and Related Processes 7
Rameshwar25 IATF ADP - How to proceed for new auditor qualification IATF 16949 - Automotive Quality Systems Standard 17
S Do suppliers of prototyping components need to undergo supplier qualification? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Qualification of weights used for curing epoxy Manufacturing and Related Processes 3
M Qualification of Freezer with IQ and PQ but no OQ Qualification and Validation (including 21 CFR Part 11) 2
S Supplier Qualification - How do we determine which suppliers to qualify? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 CE Marking (Conformité Européene) / CB Scheme 3
J Simple supplier evaluation qualification process form that includes Risk Assessment Document Control Systems, Procedures, Forms and Templates 2
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
P Qualification of a Temperature Controlled Unit have to be empty? Qualification and Validation (including 21 CFR Part 11) 5
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
O AS9100 AQMS AEA Qualification Audits 4 Full QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C MSA for Non Manufacturing - Design Validation, Characterization and Qualification Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
L Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
Z Is PPAP Re-qualification needed in case of not quoted dimension change? APQP and PPAP 4
A Tracking Calibration and Qualification in an MS Excel Spreadsheet Calibration and Metrology Software and Hardware 6
P FDA has just released the forms for "Small Business Qualification and Certification" Other US Medical Device Regulations 6
P Vision Measurement System - Software Program Qualification Qualification and Validation (including 21 CFR Part 11) 6
C Process Qualification Sample size Document Control Systems, Procedures, Forms and Templates 6
P CMM Equipment Validation and Qualification Approach ISO 13485:2016 - Medical Device Quality Management Systems 11
M Chosing a procedure title - "Validation of equipment" or "Qualification of equipment" Document Control Systems, Procedures, Forms and Templates 8

Similar threads

Top Bottom