Corrective Action for NCs (nonconformances)

[AndyN]

There are some deeply disturbing issues going on at this organization. It seems to me that if there is basic lack of understanding of how to respond to an audit finding, then the stage 2 audit is going to be a train wreck.

By the OP's admission they don't know much about this, but by virtue of the posts, appears to be fundamentally involved in the implementation. My advice is to delay/postpone the stage 2 and get some education/help to sort out these basics.......

 

[JaneB]

Whatever is written in plain english, our coordinator rejects it.. Because according to it, the qms demands that we should be very complex while making any statement.

Who is the coordinator - internal to your organisation or external?

Whichever, they're wrong. Corrective actions planned should be written in very clear, plain English so that they are able to be clearly understood. And then done.

Can you provide some more background & context about what's going on? Because this sounds like more than a problem of simply how to write up CAs.

 

[ashujanu]

Exact wordings for the following Nonconformances

I have recieved many replies to my earlier query of how to write the corrective action for the NCs. people have asked many questions - i have replied to that also. but none of the replies i received have solved my main problem i.e. writing corrective action for the NCs received:

For whatever NCs we have received, we have done the corrections to close the NCs received. but I have to write the corrective action. i dont know the exact wordings. i know what to write, but finding it difficult to put it down.

so can pls pls pls pls pls pls somebody help me out with the exact wordings for the following NCs:

1. To define the controls for the outsourcing of warehousing facilities within the quality management system. - for this we have defined the procedure and prepared the work instruction that means we have shown teh steps which will be worked out for receiving, storing, disposal - the formalities in warehouse. The root cause is known, the correction is done and now only in the non-conformity report, i have to write corrective action. only MAJOR PROBLEM IS THE LANGUAGE TO BE USED

QUOTE

The organization had outsourced the warehousing (storage) facilities for the industrial chemicals. COntrols over this outsourced activity were not defined within the quality management system.

UNQUOTE


2. To define the procedure Control of Documents called for documents of external origin to be maintained - We are maintining the documents, but the list of documents is not prepared. in our central procedures we have mentioned about this documents of external origin, the format is also prepared, we know what documents are required. again the same old problem of writing corrective action for this NC.

NC which was mentioned by the auditor is:

QUOTE

Procedure for Control of Documents called for documents of external origin to be maintained in format . The same was not done. The procedure mentioned that certain BIS requirements, equipment manuals, regulations/acts/codes, etc were applicable to the organization as a part of service execution requirements

UNQUOTE
.
3. Evidencing monitoring of customer perception as to whether the organization had met customer requirements. - NC which was mentioned by the auditor is:

QUOTE
There was no evidence of monitoring of customer perception as to whether the organization had met customer requirements. The organization had identified formats for Annexures 1 & 2 for customer satisfaction survey & customer feedback form (in case customer did not respond to the satisfaction survey) respectively.
UNQUOTE

SAME OLD PROBLEM of writing corrective action for this NC.

4. Evidence of conforming to maintaining the records of inspection for the various parameters as identified in the specification sheets - NC which was mentioned by the auditor is:.

QUOTE:

Quality Plan called for maintaining the records of inspection of the product for the various parametersas identified in the specification sheets. Evidence of conformance to the same was not being maintained.

UNQUOTE
SAME OLD PROBLEM of writing corrective action for this NC.
5. NC which was mentioned by the auditor is:
procedure for control of nonconforming products. The same was not adequate with respect to the following -

• The requirement for dealing with the nonconforming product were restricted to rework & reinspection. Possibility of detection of nonconforming product after delivery or use had started &/or release of the nonconforming product under concession was not evaluated
• Requirements for dealing with nonconformities with regards to the service provision done by the organization were not defined.

SAME OLD PROBLEM of writing corrective action for this NC.

REGARDS

 

[ashujanu]

Our coordinator is from our organisation itself.

My main problem is how to write corrective action i.e. exact wordings of this NC:

1. To define the controls for the outsourcing of warehousing facilities within the quality management system. - for this we have defined the procedure and prepared the work instruction that means we have shown teh steps which will be worked out for receiving, storing, disposal - the formalities in warehouse. The root cause is known, the correction is done and now only in the non-conformity report, i have to write corrective action. only MAJOR PROBLEM IS THE LANGUAGE TO BE USED

QUOTE

The organization had outsourced the warehousing (storage) facilities for the industrial chemicals. COntrols over this outsourced activity were not defined within the quality management system.

UNQUOTE


2. To define the procedure Control of Documents called for documents of external origin to be maintained - We are maintining the documents, but the list of documents is not prepared. in our central procedures we have mentioned about this documents of external origin, the format is also prepared, we know what documents are required. again the same old problem of writing corrective action for this NC.

NC which was mentioned by the auditor is:

QUOTE

Procedure for Control of Documents called for documents of external origin to be maintained in format . The same was not done. The procedure mentioned that certain BIS requirements, equipment manuals, regulations/acts/codes, etc were applicable to the organization as a part of service execution requirements

UNQUOTE
.
3. Evidencing monitoring of customer perception as to whether the organization had met customer requirements. - NC which was mentioned by the auditor is:

QUOTE
There was no evidence of monitoring of customer perception as to whether the organization had met customer requirements. The organization had identified formats for Annexures 1 & 2 for customer satisfaction survey & customer feedback form (in case customer did not respond to the satisfaction survey) respectively.
UNQUOTE

SAME OLD PROBLEM of writing corrective action for this NC.

4. Evidence of conforming to maintaining the records of inspection for the various parameters as identified in the specification sheets - NC which was mentioned by the auditor is:.

QUOTE:

Quality Plan called for maintaining the records of inspection of the product for the various parametersas identified in the specification sheets. Evidence of conformance to the same was not being maintained.

UNQUOTE
SAME OLD PROBLEM of writing corrective action for this NC.
5. NC which was mentioned by the auditor is:
procedure for control of nonconforming products. The same was not adequate with respect to the following -

• The requirement for dealing with the nonconforming product were restricted to rework & reinspection. Possibility of detection of nonconforming product after delivery or use had started &/or release of the nonconforming product under concession was not evaluated
• Requirements for dealing with nonconformities with regards to the service provision done by the organization were not defined.

SAME OLD PROBLEM of writing corrective action for this NC.

REGARDS

 

[Sam4Quality]

Since Ashwini is in dire needs, without going any further into whats the coordinators affinity to complex documentation, let me put down some of the CA's. Senior Covers, please correct me where I am not in line, 'technically' (so it came!) incorrect or just not in this world (Venus?).

Originally Posted by ashwinirane

1. To define the controls for the outsourcing of warehousing facilities within the quality management system. - for this we have defined the procedure and prepared the work instruction that means we have shown teh steps which will be worked out for receiving, storing, disposal - the formalities in warehouse. The root cause is known, the correction is done and now only in the non-conformity report, i have to write corrective action. only MAJOR PROBLEM IS THE LANGUAGE TO BE USED

QUOTE
The organization had outsourced the warehousing (storage) facilities for the industrial chemicals. Controls over this outsourced activity were not defined within the quality management system.
UNQUOTE

NC#1: Controls over this outsourced activity were not defined within the quality management system.
Root Cause: Lack of adequate review of documented controls of processes.
Correction: Controls for receiving, storing, disposal of activities at the warehouse have been adequately defined and documented in the procedure. Steps to implement the controls have been documented in work instructions.
CA: All other processes related to the Warehousing facilities and other Dept. processes where controls form an important aspect, shall be reviewed for any other lack of neccesary documentation, including lack of controls, adequacy of interaction between processes, and shall be documented in order to avoid any future recurrence of such NC's.

2. To define the procedure Control of Documents called for documents of external origin to be maintained - We are maintining the documents, but the list of documents is not prepared. in our central procedures we have mentioned about this documents of external origin, the format is also prepared, we know what documents are required. again the same old problem of writing corrective action for this NC.

NC which was mentioned by the auditor is:

QUOTE
Procedure for Control of Documents called for documents of external origin to be maintained in format . The same was not done. The procedure mentioned that certain BIS requirements, equipment manuals, regulations/acts/codes, etc were applicable to the organization as a part of service execution requirements
UNQUOTE

NC#2: List of documents of external origin not maintained in format as mentioned in the Control of Documents procedure
Root Cause: Ignorance on the part of the QA team (I am not convinced )
Correction: Format for the documents of external origin has been prepared and the list maintained
CA: Further training shall be conducted for the QA team on the understanding of the standards and the importance of documentation (I am not convinced )

3. Evidencing monitoring of customer perception as to whether the organization had met customer requirements. - NC which was mentioned by the auditor is:

QUOTE
There was no evidence of monitoring of customer perception as to whether the organization had met customer requirements. The organization had identified formats for Annexures 1 & 2 for customer satisfaction survey & customer feedback form (in case customer did not respond to the satisfaction survey) respectively.
UNQUOTE

SAME OLD PROBLEM of writing corrective action for this NC.

NC#3: No evidence of monitoring of customer perception as to whether organization had met customer requirements
Root Cause: Lack of interest in the customers views/opinion and lack of customer importance and care on the part of the process owners (Sales/Marketing/Business Development/Customer Care etc)
Correction: To conduct documented customer satisfaction surveys and obtain customer feeback in order to identify customer perception and take appropriate measures needed for ensuring customer satsifaction.
CA: Intense training shall be provided to the process owners on 'Customer Satisfaction', 'Understanding Customer Needs' etc.

4. Evidence of conforming to maintaining the records of inspection for the various parameters as identified in the specification sheets - NC which was mentioned by the auditor is:.

QUOTE:
Quality Plan called for maintaining the records of inspection of the product for the various parametersas identified in the specification sheets. Evidence of conformance to the same was not being maintained.
UNQUOTE

SAME OLD PROBLEM of writing corrective action for this NC.

NC#4: Records of inspection of product for the various parameters as identified in the spec sheet were not beign maintained (as mentioned in the Quality Plan)
Root Cause: What is the root cause here? Format was there but did not fill it? Misplaced it? No format at all for recording?
Correction: (Assuming there is no format) The format for the 'Inspection of Product' has been developed and implemented. Records of inspection are now maintained.
CA: Based on root cause. Unclear.

5. NC which was mentioned by the auditor is:




procedure for control of nonconforming products. The same was not adequate with respect to the following -

• The requirement for dealing with the nonconforming product were restricted to rework & reinspection. Possibility of detection of nonconforming product after delivery or use had started &/or release of the nonconforming product under concession was not evaluated
• Requirements for dealing with nonconformities with regards to the service provision done by the organization were not defined.

SAME OLD PROBLEM of writing corrective action for this NC.

NC#5: Procedure for Control of Nonconforming Products was not adequate due to the above two points.
Root Cause: There may be many implications on this. Ashwini needs to identify the exact root cause. Maybe there was no provision/policy for such before, maybe such incident never happened before etc.
Correction: Both the above points were added to the procedure.
CA: Based on root cause. Unclear.


I don't think there is any better 'technical language' than this (unless you want to mention the standards clauses with corresponding NCs). When he has written the NC's in plain simple English, why he insists on a complex language is out of my grey cells reasoning. Try helping the coordinator with a crash course on complexity management.


I hope this helps you. However, wait for other senior covers' comments on my corrective actions and their own too.


Ciao.

___________________________
Sincerely, SAM
"To achieve the impossible, it is precisely the unthinkable that must be thought!"

 

[Sam4Quality]

Re: Exact wordings for the following Nonconformances

Dear Ashwini

Please refer to your original post. I have replied to your 5 NCs.

SAM

 

[Jim Wynne]

Our coordinator is from our organisation itself.

My main problem is how to write corrective action i.e. exact wordings of this NC: <snip>

In order to get help with this, you need to tell us exactly what you've done insofar as corrective action is concerned. You say that your problem is in writing the thing in "technical" language, so I suggest that you write it out in your own words and post your work here so we can help you to make it more difficult to read. We can't help to write things that we don't know anything about.

 

[ashujanu]

Thanks a lot for your reply. THis is what i wanted.

for yr info, i have now worded the 5 NCs as follows:

For NC (1) - warehousing:

Root Cause: Lack of adequate review of documented controls of processes.


Correction : Controls for receiving, storing, disposal of activities of industrial chemicals at the warehouse have been adequately defined and documented in the procedure. Steps to implement the controls have been documented in work instruction..
.
Corrective Action : All other processes related to the Warehousing facilities and other processes where controls form an important aspect, shall be reviewed for any other lack of necessary documentation, including lack of controls, adequacy of interaction between processes, and shall be documented in order to avoid any future recurrence of such NC.

For NC (2) - documents of external origin:

Root Cause: Though the format for documents of external origin was prepared but the list is not maintained

Correction: List of documents of external origin is now maintained in format and the list will be updated on daily basis.

Corrective Action : There should be understanding of the standards and the importance of documentation by the HODs.

For NC (4) - evidencing monitoring of customer perception:

Root Cause: Lack of interest in the customers views/opinion and lack of customer importance and care on the part of the process owners be it for sales, business development etc.

Correction: To conduct documented customer satisfaction surveys and obtain customer feedback in order to identify customer perception and take appropriate measures needed for ensuring customer satisfaction.

Corrective Action: For every sale transaction, customer feedback form will be sent to the customers within 48 hours of completion of transaction and rigorous follow up to be done till the HOD gets the customer feedback form duly filled, signed and stamped. This is done for the HOD to understand the concept of 'Customer Satisfaction, & 'Understanding Customer Needs' etc.

For NC (5) : Records of inspection of product for the various parameters

Root Cause : Records of inspection of product for the various parameters as identified in the specification sheet were not being maintained.

Correction: The format for the 'Inspection of Product' has been developed and implemented. Records of inspection are now maintained.

Corrective Action : All processes related to the inspection of product will be maintained and it shall be reviewed every time when the consignment is ready for despatch.

For NC (6) : . procedure for control of nonconforming products.

Root Cause : The requirement for dealing with the nonconforming product & non conforming services were not defined.

Correction : NOT SURE WHAT TO WRITE….

Corrective Action : All HODs will evaluate possibility of detecting nonconforming product & non conforming service (after delivery or even after usage)


if you think that there is any change required in above mentioned root cause / correction / corrective action, do pls feel free to inform me.

bye

ashwini
p.s. HODs mean Head of Division

Since Ashwini is in dire needs, without going any further into whats the coordinators affinity to complex documentation, let me put down some of the CA's. Senior Covers, please correct me where I am not in line, 'technically' (so it came!) incorrect or just not in this world (Venus?).

NC#1: Controls over this outsourced activity were not defined within the quality management system.
Root Cause: Lack of adequate review of documented controls of processes.
Correction: Controls for receiving, storing, disposal of activities at the warehouse have been adequately defined and documented in the procedure. Steps to implement the controls have been documented in work instructions.
CA: All other processes related to the Warehousing facilities and other Dept. processes where controls form an important aspect, shall be reviewed for any other lack of neccesary documentation, including lack of controls, adequacy of interaction between processes, and shall be documented in order to avoid any future recurrence of such NC's.
<snip>

 

[AndyN]

There is an inherent danger in writing (and posting) a response for an audit corrective action of behalf of someone who posts their non-conformities here.......

If the response is copied (wholesale) how can it be assured that a) the recipient can adequately demonstrate 'ownership' of the corrective action? and b) there is any transfer of knowledge as to how to determine the actions necessary to address such issues in the future? There are probably more considerations which I haven't given time to.

Although it is attractive to tell folks 'just do this' it is also dangerous - as in this case - without knowing a lot more. IMHO, people have inadvertently stepped over a number of important points in haste to provide a solution, which - ultimately - won't help.

 

[samsung]

There is an inherent danger in writing (and posting) a response for an audit corrective action of behalf of someone who posts their non-conformities here.......

If the response is copied (wholesale) how can it be assured that a) the recipient can adequately demonstrate 'ownership' of the corrective action? and b) there is any transfer of knowledge as to how to determine the actions necessary to address such issues in the future? There are probably more considerations which I haven't given time to.

Although it is attractive to tell folks 'just do this' it is also dangerous - as in this case - without knowing a lot more. IMHO, people have inadvertently stepped over a number of important points in haste to provide a solution, which - ultimately - won't help.

Good reasoning. It appears that till now the OP had not taken any effective CA probably because of ........don't know why but certainly the issue may not have been solely concerned with his inability to wrap the things under the cover of 'technical language'. Language shouldn't be an issue in any way as long as appropriate actions are timely taken in whatever language.

Not sure upto what extent Ashwini has got to grips with the current issues. Problems are certainly deep rooted and I wish those problems don't crop up any more in future if he has really got what he wished for.

Good luck!