SBS - The best value in QMS software

To raise a NC beyond the audit scope? Two signatures were missing

Jean_B

Trusted Information Resource
#11
Can't say for aerospace (AS) as it's not my industry. Don't expect it to be all that different though.
In general, if I don't know a regulation nor its scope of application i am careful of stating a company does not comply.
As an auditor you must include observation, criteria & finding. Do you know enough about all of them?

They might be exempt (RoHS), below a threshold (REACH), have a grandfather guidance in effect (more a thing of the past now, ha), not active in the enforcing region (MDSAP full package or part?), not in that part of the supply chain (ISO allows 13485 certification for distributors or suppliers of manufacturers, but indicates requirements should be selected as applicable), not (yet) with a product in a lifecycle phase that demands it (developing, but not manufacturing), at the end-of-life phase with requirements that no longer apply (if you're only doing service and maintenance, do you keep up your manufacturing controls or only the production masters and production records you've maintained).

Different example: 150 km/h is generally a speed in excess of the limit. But not on the German Autobahn (if there are no roadworks). Not in the Netherlands, if it is a police car following proper procedure in a chase. Not for a helicopter in general. You need to know the case, and what rules and exceptions apply before you can honestly stand behind your non-conformity.

If it is my objective to check and in scope I would ask questions, but then I would have been selected for expertise and expected to spend the effort.
If I have a forgiving organisation I might write it and then admit my mistake if proven. There's risks though: a loss of reputation which is non-trivial for an internal auditor in a high word-of-mouth environment where you might find you are later not taken seriously, or too seriously, or perhaps the company trusts your word, spends thousands fixing (manhours cost man, don't get system changes and validations involved, what about field action consequences) something which wasn't an issue but they had noone else smart enough or free enough to prove you wrong.
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#12
Can't say for aerospace (AS) as it's not my industry. Don't expect it to be all that different though.
In general, if I don't know a regulation nor its scope of application i am careful of stating a company does not comply.
As an auditor you must include observation, criteria & finding. Do you know enough about all of them?
Let's not take this too far beyond the specific topic at hand, which involves an internal audit and a documented internal requirement. A nonconformity is simply non-fulfillment of a requirement. In this case, there was non-fulfillment of a requirement, but evaluation of fulfillment of the requirement was outside the scope of the audit in question.
 
Thread starter Similar threads Forum Replies Date
qualprod Criteria to raise a Nonconformance based on KPI values ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 39
Q Practical Way to raise NCR's in an Assembly Workshop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N Any comment, if a supplier raise an NCR to the Client? Oil and Gas Industry Standards and Regulations 5
R Can a external auditor raise a finding that is already identified in Internal Audit ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Performance Evaluation - Time for a Raise? Career and Occupation Discussions 4
4 ISO 14001 videos to raise awareness ISO 14001:2015 Specific Discussions 1
A Shall we raise SCAR/CAR for every defect as per our current procedure? Nonconformance and Corrective Action 4
N I Want A Raise! (joke) Funny Stuff - Jokes and Humour 2
Q Waiting for Audits to raise Nonconformity Reports? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q How raise en ECO starting from a NC - ECO after NCR? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Encouraging Teams to raise Issues ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
O Who can raise a Corrective Action? Nonconformance and Corrective Action 7
Stijloor Goldman Posts Profit and Will Raise $5 Billion World News 2
M Thermocouples prices raise General Measurement Device and Calibration Topics 4
C Internal Audit Findings - Do I need to raise NC for amendments/revisions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S How one can raise increment request to TOP management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Asking for a Raise and Justifying a Raise Career and Occupation Discussions 30
R NCR & CAR - How to use & where to raise Nonconformance and Corrective Action 23
Marc US Airlines raise base fares - April 2006 Travel - Hotels, Motels, Planes and Trains 1
M Record Falsification - What clause to raise a non-conformity? Records and Data - Quality, Legal and Other Evidence 20
A Employee Involvement - Employees shall have the authority to raise nonconformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
T Class A PRTD beyond 300°C General Measurement Device and Calibration Topics 0
B Go Beyond ISO 9001 WITH IATF 16949 (January 28) [Paid] Training - Internal, External, Online and Distance Learning 1
M Calibration certificates avowing accuracy beyond the uncertainty limits? Measurement Uncertainty (MU) 7
Hershal Star Trek Beyond (ST 13) - 2016 Coffee Break and Water Cooler Discussions 4
N "Beyond Economic Repair" - Scrapping Customer Material - DCMA Quality Manager and Management Related Issues 7
somashekar Authorization to use shelf life sensitive materials beyond its valid shelf life... Manufacturing and Related Processes 7
2 DOE to minimize Noise Contributions that enlarge the Variation beyond Part-Part Quality Tools, Improvement and Analysis 5
C Controlling Documents: Beyond the standard, how do we truly define what to control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Calibration and Customer 'Requirements' - Something Stupid Beyond Belief General Measurement Device and Calibration Topics 40
U Beyond words and wonderment Coffee Break and Water Cooler Discussions 1
J Taking Lean beyond 5S - Commercial Printer Lean in Manufacturing and Service Industries 10
Jen Kirley Beyond Compliance: Value-added auditing for system performance The Reading Room 9
R Beyond Lean manufacturing - Operation management / Performance improvement Lean in Manufacturing and Service Industries 1
BradM 29th Olympics in China - Beyond the opening Coffee Break and Water Cooler Discussions 82
R Getting started (beyond the standard) and getting up to speed with AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the Risk Assessment ISO 14971 - Medical Device Risk Management 4
Douglas E. Purdy Beyond PDCA by Praveen Gupta Philosophy, Gurus, Innovation and Evolution 126
A Do you register NC's beyond Internal Audits? Internal Auditing 13
Casana Beyond CQE: Any suggestions to improve my knowledge further? Statistical Analysis Tools, Techniques and SPC 25
J ISO 9001 - Product ID & Traceability - Beyond our door? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Supplier audit Medical Device and FDA Regulations and Standards News 2
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6

Similar threads

Top Bottom