OQ, PQ Requirement for Aerospace? Recently purchased CNC

Document Dame

Starting to get Involved
#1
Greetings all,

My company recently purchased a CNC and a friend told me we need to have Operational Qualification and Performance Qualification or it would be a problem for us during our AS9100D transition audit.


I know OQ, PQ is a requirement in the medical field, but is it required in the aerospace field too?

Thanks!
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: OQ, PQ requirement for Aerospace?

If I understand your question:

Yes I believe...you would be required to perform a First Article Inspection using AS9102, to validate and verify the results of the CNC.

Just my opinion.
 

howste

Thaumaturge
Super Moderator
#3
Greetings all,

My company recently purchased a CNC and a friend told me we need to have Operational Qualification and Performance Qualification or it would be a problem for us during our AS9100D transition audit.


I know OQ, PQ is a requirement in the medical field, but is it required in the aerospace field too?

Thanks!
The relevant AS9100 requirements are in 8.5.1.1 and 8.5.1.3:

AS9100 Rev D said:
8.5.1.1 Control of Equipment, Tools, and Software Programs

Equipment, tools, and software programs used to automate, control, monitor, or measure production processes shall be validated prior to final release for production and shall be maintained.
AS9100 Rev D said:
8.5.1.3 Production Process Verification

The organization shall implement production process verification activities to ensure the production process is able to produce products that meet requirements.

NOTE: These activities can include risk assessments, capacity studies, capability studies, and control plans.

The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation, and tooling are able to produce parts and assemblies that meet requirements. This activity shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, production process changes, tooling changes).

NOTE: This activity can be referred to as First Article Inspection (FAI).
The organization shall retain documented information on the results of production process verification.
AS9100 doesn't specifically require First Articles to AS9102. You should verify if your customers require FAI per the AS9102 requirements.
 

Eredhel

Quality Manager
#6
We're also a CNC shop with AS9100. The AS9102 first article is not an AS9100 requirement, it's a guidance in its Annex. But it can often be customer driven. I think you'll find most AS9102 requirements will be part driven, not machine driven. But until you have customers requiring it you don't need to. If an auditor requires it have them "show you the shall". We verify with First Part Inspections and our own internal First Articles, that meets the standard but is not an AS9102 FAIR.
 
Thread starter Similar threads Forum Replies Date
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 6
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
I Laboratory Fridge / Freezer Inventory - Requirement(s) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
P Obstruction alarm requirement ISO 80601-2-12 Other Medical Device Related Standards 1
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
C Industrial scales and MSA (IATF 16949 requirement 7.1.5.1.1) IATF 16949 - Automotive Quality Systems Standard 30
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 1
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 5
V 3 PQ lots mentioned as requirement in PPAP. Is this necessary? APQP and PPAP 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO17020 - Equipment calibration requirement General Measurement Device and Calibration Topics 3
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
D Vietnam requirement of CE mark for medical devices CE Marking (Conformité Européene) / CB Scheme 4
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Gage R&R studies for identical Devices - Need to confirm the requirement to perform them Reliability Analysis - Predictions, Testing and Standards 2
A Microbial exposure during use - Requirement 11.1(c) EU Medical Device Regulations 1
D Requirement of Pharmacovigilance (Drug Safety) Risk Based Strategic and Tactical Audit Plan General Auditing Discussions 0
S Device name change and label color change EU requirement? Other Medical Device Regulations World-Wide 6
I Receiving Inspection Requirement in IATF IATF 16949 - Automotive Quality Systems Standard 3
C ISO 17025 2017, Requirement 6.6.3 - Communicate requirements to external providers ISO 17025 related Discussions 4
D AS9100 Inspection records - Is there a requirement to have gauge ID and calibration status AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A EU-MDR Annex I Requirement 10.1(d) EU Medical Device Regulations 3
padraick63 REACH and ROHS Requirement for a Molded Part REACH and RoHS Conversations 1
M Requirement for manufacturing process validation in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 8
J IMDS for Trucks in USA as a requirement RoHS, REACH, ELV, IMDS and Restricted Substances 1
D FDA Date Format Requirement US Food and Drug Administration (FDA) 0
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
M IATF 16949 - 8.5.6.1.1 Providing a list of process controls: Does this requirement add value to QMS? IATF 16949 - Automotive Quality Systems Standard 4
V "Manufacturer Symbol on Device is missed due to space constraint" EU requirement EU Medical Device Regulations 11

Similar threads

Top Bottom