A question of Non-conformity specifics - AQAP2120 (The MOD's equivalent to ISO9001)

Baalberith

Starting to get Involved
#1
I am from the United Kingdom.

My ISO9001 & AQAP2120 certified company is currently undergoing a 2nd party audit by a Ministry Of Defence (DQAFF) (Department of Quality Assurance Field Force) Auditor, against AQAP2120 (The MOD's equivalent to ISO9001, but with a few additions).
The Auditor is raising QDR?s (Quality Deficiency Reports) Similar to ISO9001 Non-Conformities.


My hypothetical question to you is this; If we have a specific piece of measuring equipment, or Work Instructions that are used for an Automotive customer like Jaguar Land Rover, or General Motors, and the MOD Auditor discovers that piece of equipment out of calibration, or JLR / GM Work instruction(s) out of date / out of issue, can he raise that as a QDR, or is he only allowed to raise a QDR against things that affect the (his) MOD contract only?
Your help & comments would be appreciated.
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Leader
Admin
#2
Re: A question of Non-conformity specifics

The scope of the audit should have been covered in the early stages of the audit (in a 3[sup]rd[/sup] party audit, would have been during the opening meeting). I would think that, typically, an auditor would stick to the hardware that is representative of the products being procured by the organization they are performing the audit on behalf of, but sometimes, auditors forget the boundaries of the system they are supposed to assess and roam aimlessly through the plant.

If I were you, I would bring this up for discussion, BEFORE the auditor leaves.

The auditor escort guide should remind the auditor if he is auditing something that is outwith of the scope.
 
Thread starter Similar threads Forum Replies Date
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
Q FDA's jurisdiction over Non-Research Medical Clinics - Question US Food and Drug Administration (FDA) 2
M MEDDEV 2.12.1 rev 6 Trending of Non-Reportable Events question ISO 13485:2016 - Medical Device Quality Management Systems 8
G Japan's PMDA Response to Question on Trade Show Display of Non-approved Device Japan Medical Device Regulations 9
D What do you think of Chat GPTs answer to this Risk Acceptability question? ISO 14971 - Medical Device Risk Management 4
M ISO 13485 Supplier Question ISO 13485:2016 - Medical Device Quality Management Systems 13
A Question regarding new VDA_AIAG fmea approach for process FMEA FMEA and Control Plans 0
Ed Panek FDA Submission Question US Medical Device Regulations 2
M Cleanroom Question Manufacturing and Related Processes 10
T Aircraft GAPP Software Testing Compliance Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
sonflowerinwales Quick question M3 screw plug gauge AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
M An interesting question about import company Other Medical Device Regulations World-Wide 5
Sam.F Question about training Training - Internal, External, Online and Distance Learning 20
B Labeling question about different manufacturers on a single label Manufacturing and Related Processes 4
J Question regarding classification of custom made device EU Medical Device Regulations 5
Sam.F Question about granite surface plates out of spec AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
B GD&T Question, True Position Confusion Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
D Initial Importer question Other US Medical Device Regulations 1
Ed Panek Calibration question Manufacturing and Related Processes 4
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
sonflowerinwales Metric or Imperial; that is the question... After Work and Weekend Discussion Topics 6
M Can someone help me with this CMM programming question? Manufacturing and Related Processes 2
A A strange question about predicate device selected in 510(k) submission Medical Device and FDA Regulations and Standards News 8
S Question regarding AQL - ISO 3951 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 6
JoeRandom11 Question about Customer Supplied Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485: 2016 Lot numbering question ISO 13485:2016 - Medical Device Quality Management Systems 4
S Nadcap - Heat Treatment Proof of Verification question for Digital results AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
JoeRandom11 Question of Calibration Cycles AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Software Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 10
B 8.5.1.1 Control Plan - question audit NC IATF 16949 - Automotive Quality Systems Standard 5
C Document Identification Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Question regarding PCR workstation Fume Hood upon first use ISO 13485:2016 - Medical Device Quality Management Systems 0
Moncia ISO 9001 calibration question please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Quality Specialist Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
D ISO 13485--Question regarding performing calibrations in house. ISO 13485:2016 - Medical Device Quality Management Systems 13
S Document numbering question? ISO 13485:2016 - Medical Device Quality Management Systems 7
J Has the facility been inspected? question in Certificate to Foreign Government application Other US Medical Device Regulations 0
M ESTAR 510(k) submission question Medical Device and FDA Regulations and Standards News 0
J Question on clause 5.2.2 IEC 62304 - Medical Device Software Life Cycle Processes 2
Ed Panek ISO 15223 Question EU Medical Device Regulations 2
R Question: Cg/Cgk formula Capability, Accuracy and Stability - Processes, Machines, etc. 2
J Quick question on responsible person's experience requirements UK Medical Device Regulations 3
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
3 Scope question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Question regarding "Customer Property" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
T Noob question regarding sample size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K 510(k) Manufacturer question (private label and manufacture under another persons 510(k)) US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom