Write down same nonconformity in several processes?

qualprod

qualprod

Trusted Information Resource
#1
#1
Hi all

Please share your opinion in this issue.
Auditing a 9001 system.

When auditing the responsible of the Management system (Coordinator) in the process management system, it was found that for Some documents, the responsible didn´t follow what the procedure stated.

The procedure states that responsible of the process have to revise the document and finally the General manager have to approve them.

But in this case the coordinator revised all the documents of all the processes and General manager approved them.
So a NC was written down for this process.

This person (coordinator) is in charge to receive approved documents from the general manager, then convert them in PDF , then load final files into the system, so that the new releases are available to all the people.

But when auditing the next process (human resources), and one document is audited (a job description of the responsible of the process), it was revised to check authorities and responsibilities.

Both issues (authorities and responsibilities) were ok, so were in compliance, but....... such document was one for which a NC was written down, and the same happened when audited the third process (sales) , So, the question is should I write down a new NC in these last two processes, or is enough with the first one?

Please give you advice.

Thanks
 
Elsmar Forum Sponsor
A

AMIT BALLAL

Trusted Information Resource
#3
#3
It depends on the organization. If you feel the NC raised at one place will be accepted, properly treated by all processes and will be horizontally deployed, you can raise a single NC. If not, better to write an NC for all the processes where found.
 
Last edited:
qualprod

qualprod

Trusted Information Resource
#4
#4
AMIT BALLAL said:
It depends on the organization. If you feel the NC raised at one place will be accepted, properly treated by all processes and will be horizontally deployed, you can raise a single NC. If not, better to write an NC for all the processes where found.
Click to expand...
Is there a rule in iso to follow for this case?if written down against the last two processes it may seem that they are responsable of the NC , when it was actually the coordinator’s fault.

I think that when we audit a process we are measuring their performance and in this case it was not their fault.
Please share your opinions, thanks[/QUOTE]
 
Last edited by a moderator:
RoxaneB

RoxaneB

Super Moderator
Super Moderator
#8
#8
I'm not quite sure I understand. It sounds like the issue is with the doc control process, not the individual departments - presuming the coordinator is in some admin role? Or did I mis-read this issue?

If the issue is in the doc control process, then I'd suggest it's one nonconformance written up, but it's a systemic issue that may require an investigation into the entire document control process (i.e., responsibilities, efficiency, effectiveness, etc.)
 
qualprod

qualprod

Trusted Information Resource
#9
#9
RoxaneB said:
I'm not quite sure I understand. It sounds like the issue is with the doc control process, not the individual departments - presuming the coordinator is in some admin role? Or did I mis-read this issue?

If the issue is in the doc control process, then I'd suggest it's one nonconformance written up, but it's a systemic issue that may require an investigation into the entire document control process (i.e., responsibilities, efficiency, effectiveness, etc.)
Click to expand...
Yes Roxane, is control of documents. Sound good your suggestion, thanks to all of you
 
Randy

Randy

Super Moderator
#10
#10
Either determine the cause of the problem and fix it or start eliminating documents (especially the ones that are nice to have but there is no real need for them). You pretty much only need to document what's required by the standard itself, the law and other obligations (can include customers), and those necessary, as determined by you, to demonstrate effectiveness of the QMS.

I'll guarantee, sight unseen, that you have a ton of documents that are nice to see and are fluff smoke & mirrors
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Quality Policies - Necessary to write down Numeric Objectives IN the Policy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
L How to write a proper defect description in a NCR Nonconformance and Corrective Action 4
qualprod When to write up a nonconformance and require a NCR - We produce labels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Validation of existing equipment - I have been asked to write a quality assessment for equipment ISO 13485:2016 - Medical Device Quality Management Systems 13
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
GStough Have You Had to Write a NC Against a Quality Manual in a Supplier Audit? General Auditing Discussions 12
D What is the appropriate way to write a conclusion from a % contribution result? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Who should write Departmental Work Instructions Document Control Systems, Procedures, Forms and Templates 6
L Requirement to write a Detailed Inspection Plan (DIP) APQP and PPAP 5
E How to write requirements for Medical App Validation and Verification IEC 62366 - Medical Device Usability Engineering 7
Z What to write on A3 Methodology Recognition Certificates? Six Sigma 2
T SOP for How to Write a Specification for Raw Materials and Finished Good ISO 13485:2016 - Medical Device Quality Management Systems 3
alonFAI Update an existing QMS manual or write a new one for AS9100C Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E How to write a Project Plan to Overhaul our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
C How to write a Post Market Surveillance REPORT (not procedure) EU Medical Device Regulations 4
E How to write an Aseptic Media Fill Validation Document Other US Medical Device Regulations 2
Q Who must write Quality Manual as per ISO 9001 Clause 5.5.2? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
J Can An External Auditor Also Write The Same Non-Conformance As An Internal Auditor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C How to Write Procedures without too many Details ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B How do I tell my boss to write neatly without offending her? Career and Occupation Discussions 8
W How to write an EASA 145 Quality Manual EASA and JAA Aviation Standards and Requirements 3
N Do I Need to Write a CAR for..... (All Opinions Wanted :) ) ISO 13485:2016 - Medical Device Quality Management Systems 7
B I'm trying to write detailed Customer Service Work Instructions Customer Complaints 10
T How do I control web-based asp forms/rpts that write to and pull from an Access DB Document Control Systems, Procedures, Forms and Templates 4
P Internal Audit Corrective Actions - Can a CB write an NC on an in-process CA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 27
J How to Write the Planned Interval to Conduct Internal Audit, Management Review, etc.. ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to write a US FDA proof MDR procedure? Other US Medical Device Regulations 5
Y New Guidance for the Industry - How to write a Request for Designation (RFD) US Food and Drug Administration (FDA) 0
Q How to write Statement of Purpose for a Law School Admission Career and Occupation Discussions 9
K How to Write a User's Manual for Peachtree - Seeking help Document Control Systems, Procedures, Forms and Templates 4
K ISO 22000 requirement to write a Food Safety Manual Food Safety - ISO 22000, HACCP (21 CFR 120) 2
E How to write a Validation Risk Management Plan for Equipment ISO 14971 - Medical Device Risk Management 5
A How to write Quality Manual? Point to consider Quality Management System (QMS) Manuals 2
M How to write a Nonconformance Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
S How to write a Prerequisite Program (PRP) for food industry ? Food Safety - ISO 22000, HACCP (21 CFR 120) 11
B How to write a SOP for a Medical Device Document Control Systems, Procedures, Forms and Templates 4
E Software to Write and Control Work Instructions? Document Control Systems, Procedures, Forms and Templates 7
A How to write quality policy? Basics of Quality policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Is it required to write a formal corrective action on any nonconformance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 29
M How to write the Essential Requirements EU Medical Device Regulations 14
R How to write a Capacity Plan Quality Manager and Management Related Issues 2
N Four CMMs and would like to write programs for intermediate checks General Measurement Device and Calibration Topics 5
A How to write a Quality Policy Statement Quality Manager and Management Related Issues 11
Jen Kirley How does a Demingite write a good self evaluation? Career and Occupation Discussions 5
E Starting to write a Quality System Manual - Import/export medical devices - Need help ISO 13485:2016 - Medical Device Quality Management Systems 1
L How to write Executive Summary for Health Canada medical device applications Canada Medical Device Regulations 4

Similar threads

Top Bottom