Managing a Significant Number of Outstanding Non-Conformities

S

Stuart Williams

#1
Hi Everybody

I am at a new company and I have found that out QMS system is not in tip-top condition. We have started to do things properly, and during our audit programme we are finding a significant number of non-conformities and recording them properly.

The position I find myself in is that I have a significant number of outstanding NCs. The management team here is now pretty well engaged and the NCs are getting steadily resolved, but I do have a continuing assessment in a couple of weeks time and can only reasonably expect that there are a number of NCs outstanding, unless there is some kind of miracle in the meantime.

The standard requires that we take action to prevent non-conformities occurring in the future, and we have a process for recording and managing non-conformities, which specifies that the auditor will specify a required date for corrective action.

Is it acceptable to have outstanding NCs at an audit? What criteria would make them acceptable, perhaps if they are in progress and the required date is in the future?

Any help in this matter would be much appreciated.

Kind regards

Stuart Williams
 
Elsmar Forum Sponsor
P

PaulJSmith

#2
Re: Managing Non-Conformities

Hi, Stuart!
Welcome to The Cove!

There is nothing wrong with having open NCs during an audit. In fact, as long as you are following your Noncon procedure, it is a fine opportunity to demonstrate that with a real example.

It's awesome that your management team is getting involved, too. That's essential to success.

Good luck with your audit.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#3
Re: Managing Non-Conformities

Hi Everybody

I am at a new company and I have found that out QMS system is not in tip-top condition. We have started to do things properly, and during our audit programme we are finding a significant number of non-conformities and recording them properly.

The position I find myself in is that I have a significant number of outstanding NCs. The management team here is now pretty well engaged and the NCs are getting steadily resolved, but I do have a continuing assessment in a couple of weeks time and can only reasonably expect that there are a number of NCs outstanding, unless there is some kind of miracle in the meantime.

The standard requires that we take action to prevent non-conformities occurring in the future, and we have a process for recording and managing non-conformities, which specifies that the auditor will specify a required date for corrective action.

Is it acceptable to have outstanding NCs at an audit? What criteria would make them acceptable, perhaps if they are in progress and the required date is in the future?

Any help in this matter would be much appreciated.

Kind regards

Stuart Williams
Welcome to the Cove, Stuart :bigwave:

To answer your question correctly, you need to be very clear in your definition of "outstanding". To me, "outstanding" could mean "late" and could either mean "NC's that are not closed, and the corrective actions are being implemented prior to the specified date" (which is acceptable) or "NC's that are not closed, but the corrective actions are not being implemented by the implement date" (which if those happen a lot, will indicate a systemic issue, which is not acceptable). This needs to be clearly explained to your CB.

As long as your internal audit NC resolution process recognizes this distinction and corrective actions are being implemented according to planned arrangements, you should encounter no problems with your CB regarding "NC's in process".

Brian :rolleyes:
 

somashekar

Staff member
Super Moderator
#4
Hi Everybody

I am at a new company and I have found that out QMS system is not in tip-top condition. We have started to do things properly, and during our audit programme we are finding a significant number of non-conformities and recording them properly.

The position I find myself in is that I have a significant number of outstanding NCs. The management team here is now pretty well engaged and the NCs are getting steadily resolved, but I do have a continuing assessment in a couple of weeks time and can only reasonably expect that there are a number of NCs outstanding, unless there is some kind of miracle in the meantime.

The standard requires that we take action to prevent non-conformities occurring in the future, and we have a process for recording and managing non-conformities, which specifies that the auditor will specify a required date for corrective action.

Is it acceptable to have outstanding NCs at an audit? What criteria would make them acceptable, perhaps if they are in progress and the required date is in the future?

Any help in this matter would be much appreciated.

Kind regards

Stuart Williams
Outstanding ... Significant number ... How many ?
I see a good opportunity to quickly close many with just a correction.
All NC's do not need a corrective action.
Identify those that are systemic in nature and you can address corrective action more appropriately to address many NC's of similar nature.
When you have the audit, you are fine if some NC are still open and can be justified why they are open and what has been the progress so far. No undue delay please.
 

Wes Bucey

Quite Involved in Discussions
#5
My opinion:
Good things:

  1. n/c are identified
  2. progress has begun on root cause and corrective action (if required)
Bad thing:

  1. you are focusing on the negative points versus the good plan and progress to date

Things to watch:

  1. keep records of n/c, the plan for root cause, and the corrective actions planned and/or taken
  2. finally, ensure there is a process to evaluate the corrective action to ensure it does, indeed, resolve the n/c
  3. don't confuse "corrective action" with "correction or repair"
  4. deliver documents, not anecdotes, to outside auditor
 
S

Stuart Williams

#6
Thanks everybody.

My use of Outstanding means not completed, we use SharePoint for this and have statuses of "Not Started", "In Progress and "Completed". The use of the required date in our process is not clearly defined, I think I need to do some work on that.

I think the approach I will take is to ensure that I have reviewed all of the non-conformities and make sure that the business manager has updated them with an action plan and marked the non-conformity as In-Progress. I am also going to make sure that the required date is reasonable.

I am particularly going to avoid NCs with a required date in the past and a status of "not started".

Stuart
 

Wes Bucey

Quite Involved in Discussions
#7
Thanks everybody.

My use of Outstanding means not completed, we use SharePoint for this and have statuses of "Not Started", "In Progress and "Completed". The use of the required date in our process is not clearly defined, I think I need to do some work on that.

I think the approach I will take is to ensure that I have reviewed all of the non-conformities and make sure that the business manager has updated them with an action plan and marked the non-conformity as In-Progress. I am also going to make sure that the required date is reasonable.

I am particularly going to avoid NCs with a required date in the past and a status of "not started".

Stuart
Perhaps you might breathe a little easier if by "required date" you defined it as "due date of first progress report." (Sometimes an N/C is simple and straightforward and can be resolved in a matter of minutes or hours. Other times, an N/C can be a real knotty situation, taking days or weeks just to get to the root cause and additional days or weeks to formulate a workable plan, then still more time to obtain financing and permissions to implement the plan, then still more time to run the plan and evaluate it for efficacy.)
 
Thread starter Similar threads Forum Replies Date
Q Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
M Medical Device News DHS – Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients Medical Device and FDA Regulations and Standards News 0
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
J Design Verification - Managing Changes Design and Development of Products and Processes 4
Jane's You may or may not have the same person managing Operations and QA ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Managing Internal/External RNC and Complaints in same Format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Managing Finance Processes - Identification of Sub Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Microbiology Testing - Managing a Microbiology Process Hospitals, Clinics & other Health Care Providers 2
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
G Managing Ongoing Compliance to Standards when they are Changed Misc. Quality Assurance and Business Systems Related Topics 3
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Need ideas on managing Shelf Life Studies within an organization ISO 13485:2016 - Medical Device Quality Management Systems 1
I Any recommendations on software for managing the APQP, PPAP, PFMEA, Control Plan etc? Quality Assurance and Compliance Software Tools and Solutions 2
R Managing Tooling Condition at Suppliers Supplier Quality Assurance and other Supplier Issues 6
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Looking for Practical Advice in Managing Measurement Uncertainties Measurement Uncertainty (MU) 3
L Managing ITP with an ERP system Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Form for Managing Coating Process Parameter Changes during Production Document Control Systems, Procedures, Forms and Templates 2
A Software Tools for managing a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing Inspection Records with a Database and Destroying Paper Records Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Process for Managing Documents which are Overdue for Review Document Control Systems, Procedures, Forms and Templates 17
S Q1 Manufacturing Site Assessment - Managing Post-Job 1 Changes Procedure Manufacturing and Related Processes 1
B Are there any Standards related to Managing an Airport Various Other Specifications, Standards, and related Requirements 3
Q Managing Internal and Client Complaints ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Industry Best Practices for managing outside Engineering Consultants Design and Development of Products and Processes 3
Q Process or Departments - Document Content and Managing the Process Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Filtering ECR/ECO by quality management? Managing Engineering Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing the Unexpected - Book Recommendation Book, Video, Blog and Web Site Reviews and Recommendations 1
T Internal Conflict of Interest in Managing Suppliers Supplier Quality Assurance and other Supplier Issues 2
L Managing Certificates of Analysis or Conformance for Products Quality Assurance and Compliance Software Tools and Solutions 4
T Managing Audit Reports and Schedules General Auditing Discussions 3
M Managing Changes to an SFDA Registered Device China Medical Device Regulations 6
F Who manages QI projects? Quality or PMO? Managing Six Sigma and Lean Projects Six Sigma 2
Hami812 Attribute Data Gage R&R - Managing Data Sets - Minitab Using Minitab Software 2
E Nonconformity on managing documents for Electric Arc Furnace Manufacturing and Related Processes 4
D Managing an Employee Suggestion Program Quality Manager and Management Related Issues 4
K Managing Prerequisite Programme Activities Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Non Normal Data Managing - Clements Method to get Process Characteristics Statistical Analysis Tools, Techniques and SPC 8
J Managing New and Revised Electronic Documents (Procedures) - Share Point Document Control Systems, Procedures, Forms and Templates 8
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Should ISO/QMS policy be signed by the Managing Director or anyone from Top Mgt? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Managing Quality Risks in Construction Quality Manager and Management Related Issues 14
D Managing Product Risk Management ISO 14971 - Medical Device Risk Management 1
S EOQ (Economic Order Quantity) - Use for managing Customer Orders - asking help Lean in Manufacturing and Service Industries 5
Michael Malis Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 23
A Managing and Scheduling Internal Audits Internal Auditing 5
Similar threads


















































Top Bottom