The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Google
  Web Elsmar.com
*Please be aware that SOME RECENT forum threads may not yet be indexed by Google.

View Full Version : Corrective Action for NCs (nonconformances)


ashujanu
21st March 2009, 01:35 AM
Can somebody help me out in writing corrective action (in the technical language) for the following received NCs:

1. To define the controls for the outsourcing of warehousing facilities within the quality management system.

2. To define the procedure Control of Documents called for documents of external origin to be maintained - this procedure mentions that certain BIS requirements, equipment manuals, regulations/acts/codes, etc which are applicable to the organization were not maintained.

.3. Evidencing monitoring of customer perception as to whether the organization had met customer requirements.

4. Evidence of conforming to maintaining the records of inspection for the various parameters as identified in the specification sheets.

5. For non conforming products, to also consider in the procedures,

a. to evaluate the [ossibility of detecting nonconforming products after delivery or use had started &/or release of the nonconforming product i.e. after-delivery detection of nonconforming product
b. to evaluate the requirements for dealing with nonconformities with regards to the service provision done by the organization

can somebody help me out wiriting the corrective actions (in the technical language) to the above mentioned ncs

regards

ashwini

Marc
21st March 2009, 05:33 AM
The first thing needed is your explaination, in non-technical language, of the causes of the nonconformances and what your plan is to do about the problems which have been identified.

harry
21st March 2009, 06:18 AM
All these are inadequacies or weaknesses in your procedures or system detected during the stage one audit/review. Your job is to get them corrected or rectified.

I don't use NC's for these any more. We review the auditor's comments, make the necessary corrections and update the amendment/change records according to the provisions in our system.

Sam4Quality
21st March 2009, 06:28 AM
Can somebody help me out in writing corrective action (in the technical language) for the following received NCs:

1. To define the controls for the outsourcing of warehousing facilities within the quality management system.

2. To define the procedure Control of Documents called for documents of external origin to be maintained - this procedure mentions that certain BIS requirements, equipment manuals, regulations/acts/codes, etc which are applicable to the organization were not maintained.

.3. Evidencing monitoring of customer perception as to whether the organization had met customer requirements.

4. Evidence of conforming to maintaining the records of inspection for the various parameters as identified in the specification sheets.

5. For non conforming products, to also consider in the procedures,

a. to evaluate the [ossibility of detecting nonconforming products after delivery or use had started &/or release of the nonconforming product i.e. after-delivery detection of nonconforming product
b. to evaluate the requirements for dealing with nonconformities with regards to the service provision done by the organization

can somebody help me out wiriting the corrective actions (in the technical language) to the above mentioned ncs

regards

ashwini
Have you done any corrections to close out the non-conformities? Or atleast have an action plan to close them out?

1. To define the controls for the outsourcing of warehousing facilities within the quality management system. - This appears fairly clear. You have outsourced your warehousing facilities (which forms part of your company's processes), but there is no documented evidence of controls defined for its effective operations.

2. To define the procedure Control of Documents called for documents of external origin to be maintained - Not exactly clear. Whether the procedure mentions or not and whether you are maintaining them or not.

3. Evidencing monitoring of customer perception as to whether the organization had met customer requirements. - Comments pls.

Ashwini, it would be better if you can put more light on your intended action plan for the above NC's.

Ciao.:cool:

_________________________
Sincerely, SAM

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

ashujanu
21st March 2009, 02:10 PM
Thanks for a quick reply.

we have done the corrections to close the NCs received. but I have to write the corrective action in technical langugage. i know how to write, but finding it difficult to write in technical language.

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

Jim Wynne
21st March 2009, 02:16 PM
we have done the corrections to close the NCs received. but I have to write the corrective action in technical langugage. i know how to write, but finding it difficult to write in technical language.

Why do you feel the need to use "technical language," which almost always makes things more complicated than they need to be? Describe what happened in plain English (or whatever language you need to use) and be done with it.

AndyN
21st March 2009, 02:18 PM
I didn't think that non-conformities were written at a stage 1.......a report, yes......

ashujanu
21st March 2009, 02:33 PM
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.

Jennifer Kirley
21st March 2009, 03:48 PM
Your coordinator rejects your NC language? Is this your registrar?

Randy
21st March 2009, 04:10 PM
What is the Cause of the problem?

You can't fix it unless you know what is broke...

AndyN
21st March 2009, 06:58 PM
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
21st March 2009, 10:37 PM
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
22nd March 2009, 02:04 AM
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::o

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
22nd March 2009, 02:55 AM
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
22nd March 2009, 05:35 AM
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 http://elsmar.com/Forums/images/buttons/viewpost.gif (http://elsmar.com/Forums/showthread.php?p=304164#post304164)

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 :nope:)
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 :nope:)

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. :lol:


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


Ciao. :cool:

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

Sam4Quality
22nd March 2009, 05:37 AM
Dear Ashwini

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

SAM

Jim Wynne
22nd March 2009, 08:51 AM
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. :D We can't help to write things that we don't know anything about.

ashujanu
22nd March 2009, 03:29 PM
Thanks a lot for your reply. THis is what i wanted.:D

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?).

[SIZE=2]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
22nd March 2009, 04:40 PM
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
22nd March 2009, 05:18 PM
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!

JaneB
22nd March 2009, 09:52 PM
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.

All very good points Andy.

Several things about this bother me (probably reason for the lack of responses). Not least among them are the inadequacy of the information presented, and that CA is intended to be planned & defined in advance. It isn't (shouldn't be) something written up 'after the fact' using the 'right technical language'.

I know people want to help, but sometimes responding only to an immediate question isn't the best option.

Sam4Quality
23rd March 2009, 04:38 AM
Originally Posted by AndyN http://elsmar.com/Forums/images/buttons/viewpost.gif (http://elsmar.com/Forums/showthread.php?p=304283#post304283)

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.

I think you struck a cord in me that I wasn't really looking at. And I WILL definitely exercise additional care and restrain my enthusiasm (over enthusiasm?) while replying to such posts. :whip:

Now that the 'milk is spilt', I would just like to see (I know its not a very good idea), what's Ashwini's take on this? Maybe, I am defending myself, but then why not?

Originally Posted by ashwinirane http://elsmar.com/Forums/images/buttons/viewpost.gif (http://elsmar.com/Forums/showthread.php?p=304283#post304283)

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

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

Firstly, by saying 'this is what I wanted', she knew atleast what she was saying and what she wanted; true that not all required information for adequately answering her query was given.

Secondly, if you see Ashwini's words in the CA's (her last post), she has herself given the CA's for NC (5) and (6), which I did not. Those NC's are actually number 4 and 5. She skipped numbering 3 in her NC's. She has also completely changed CA #3.

So, it is clear that my response has NOT been copied 'wholesale', and she is still waiting for more feedback. If it was only to copy, she would have simply copied it, left out of this thread and shown it to the auditor during the audit (that would have been really really wrong!).

Despite my defense, I do come to agree that I will exercise more control during future replies and avoid "inadvertently stepping over a number of important points in haste to provide a solution". :agree1:

Ciao. :cool:

P.S: I would request Ashwini to come forward with his/her comments on this.


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

Marc
23rd March 2009, 07:01 AM
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....... I don't think it's that great an issue. We see this here from time to time and it has never been an issue before. As long as we, and the poster, remember it is a public forum and that anything said here is an opinion of the poster, it's a learning issue.

Taken to the extreme, we can also say there is 'an inherent danger' in anyone using any information from any post(s) or thread(s) here.

ashujanu
23rd March 2009, 07:55 AM
This message is for ANDYN, SAMSUNG, JANEB

AND ALSO TO SAM

Hi this is Ashwini.

I read your comments about me not writing corrective action myself, showing my inadequacy, wrapping the things under the cover of 'technical language', depending on others for doing the job. I found it in bad taste that you all are blaming Mr. Sam for helping me out. If you see the links, after Mr. Sam showed me how to write corrective action, I on the basis of that and taking that as the main focus, I wrote correct worded NCs and the copy of the same was mentioned in the post. Even corrective action for NC 5 & 6. I have not copied the same thing word to word in the NCR.

There were 6 NCs which we received, out of which NC no. 3 (which I had not mentioned) was written by myself i.e. without taking anybody’s help. And this NC was regarding the vendor evaluation form where our HODs (in their great haste to complete the form) had only kept the duly filed form in the file, but it was not evaluated or signed by the HOD or Unit Head. For this corrective action was written by me because I didn’t find it that difficult compared to the other NCs.


I would like to inform you that had I wanted to be spoon fed, I would have started right from the beginning i.e. right from how to make quality plan, quality objectives, central procedures, MRM minutes and even when we had 2 internal audits, for writing the root cause, corrective action and correction I would have had approached this forum long time back. For your kind info, I had made the above mentioned documents along with the help of our internal coordinator.

My main worry was that as time is short and the main audit is exactly 12 days after the initial audit, I wanted somebody’s help in writing the corrective action. My mistake was that instead of asking for the wordings first, I should have written the corrective action, posted it on the forum and requested your help in checking it out. I didn’t wanted to fall flat on my face if the external auditors didn’t find the NCs worded properly AND THEN THEY WOULD HAVE ISSUED ANOTHER NC FOR THESE NCs J. Our internal coordinator is always stressing on putting the words in rightful order.

For your info, in our first internal audit, there were 28 NCs to which coordinator had helped me out. For the second audit, there were 11 NCs, I was told to complete all the procedures / documentation and do the root cause, corrective action & correction myself which was done in 14 days. For doing all this, I had some free time besides my regular secretarial work. Out of the 11 NCs, there were errors on my part only in 4 NCs “because of not putting the action in words properly” (as per my coordinator). Our internal coordinator is based approx. 450 km from my office i.e. he is based in another state in India ) and he will be coming to our office only a day before the main audit. We have been corresponding regularly by e-mail / phone calls, but he is so busy in his work.

Please do not think that I am giving some excuses to cover my inability or defending myself to do a simple job, but I have stated the facts as it is. Just put yourself in my place – what would you do when you don’t have anybody’s support in the office to help you out for QMS and the internal coordinator is a big pain. And the responsibility of getting the certification in time lies on you (as an MR). then you will rely on the internet – right??!!

I apologize for the agitation caused to you all and especially to Mr. Sam. It was not my intention to create such negative links. Mr. Sam is not to be blamed for helping me out and I think so with this sort of reprimand, he will think twice before to help anyone out. And not only he, even others when they read this post.

Mr. Sam I am really really sorry for the inconvenience caused to you.

Regards

Ashwini

P.S.: I am again giving below the corrective action for the NCs which I have prepared based on the feedback received from Mr. Sam and which you will see it is not copied outright:

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

Sam4Quality
23rd March 2009, 08:42 AM
I apologize for the agitation caused to you all and especially to Mr. Sam. It was not my intention to create such negative links. Mr. Sam is not to be blamed for helping me out and I think so with this sort of reprimand, he will think twice before to help anyone out. And not only he, even others when they read this post.

Mr. Sam I am really really sorry for the inconvenience caused to you.
Relax and chill Ashwini!:D Thanks for clarifying yourself regarding this issue. However, I would like to say that no one here is blaming me for helping you or anyone else out; I am sure its the other way around! And that's what the cove is for!

Andy did have a valid point there, not that I shouldn't help, just to ensure that the requester has benefitted appropriately from the help. Then, my stand was seconded by good ol' Marc.

I have really started to respect this place for imparting so much knowledge on quality and other related issues. And dont worry Ashwini, I will continue helping people in need my usual way, with a healthy pinch of caution! ;)

Ciao.:cool:

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

harry
23rd March 2009, 09:09 AM
Relax and chill Ashwini!:D Thanks for clarifying yourself regarding this issue. However, I would like to say that no one here is blaming me for helping you or anyone else out; I am sure its the other way around! And that's what the cove is for!

Thanks for your clarification Sam - literally from the horse's mouth.

Participants in international forums such as the Cove should be aware of the many differences, cultural and what nots between people from various parts of the world (east, west, north and south)

This post illustrates two extremes. The Asian way of 'giving face' and therefore keeping quiet despite knowing that something's not right versus the Western way of not mincing words and expressing their views. You can choose to get no reply and still feel good or being told that you are not doing things right (and learn something as a result of it) and feel like being told-off. Which is more beneficial is up to you to decide.

All these will be nothing if you understand the cultural differences of people from different parts of the world.

Sidney Vianna
23rd March 2009, 01:48 PM
I don't think it's that great an issue. We see this here from time to time and it has never been an issue before. As long as we, and the poster, remember it is a public forum and that anything said here is an opinion of the poster, it's a learning issue.

Taken to the extreme, we can also say there is 'an inherent danger' in anyone using any information from any post(s) or thread(s) here.Absolutely true, Marc.

But Andy does have a valid point. Many amongst us talk about the need for a meaningful root cause analysis, BEFORE a proper corrective action is devised. While, most definitely people are trying to be helpful, how can any of us perform real root cause analysis without real knowledge of the organization, their processes, the context surrounding the NC, etc.?

And, while helping is good, we should be careful (IMHO) with short term help, such as helping people "passing an audit' and focus on helping people implementing meaningful, robust, sustainable processes and systems. Too many time people come here asking for the "immediate" problem at hand, which is something like: "how do I phrase this C.A.?" And then, they vanish, until the next "crisis du jour".

Jim Wynne
23rd March 2009, 01:59 PM
Absolutely true, Marc.

But Andy does have a valid point. Many amongst us talk about the need for a meaningful root cause analysis, BEFORE a proper corrective action is devised. While, most definitely people are trying to be helpful, how can any of us perform real root cause analysis without real knowledge of the organization, their processes, the context surrounding the NC, etc.?

And, while helping is good, we should be careful (IMHO) with short term help, such as helping people "passing an audit' and focus on helping people implementing meaningful, robust, sustainable processes and systems. Too many time people come here asking for the "immediate" problem at hand, which is something like: "how do I phrase this C.A.?" And then, they vanish, until the next "crisis du jour".

The OP was asking for help in wording something he already had, not for help in devising a CA strategy. While there's nothing wrong with offering advice in that regard, we should mostly concentrate on what the OP asks for, and not what we think he/she should be asking. In that sense, there's nothing wrong, imo, and certainly no danger in helping with the issue at hand.

Sidney Vianna
23rd March 2009, 02:12 PM
The OP was asking for help in wording something he already had, not for help in devising a CA strategy. While there's nothing wrong with offering advice in that regard, we should mostly concentrate on what the OP asks for, and not what we think he/she should be asking. Sometimes, you have to tell someone they are asking the wrong question.

Look at your current "signature text":It isn't that they can't see the solution. It is that they can't see the problem.

Jim Wynne
23rd March 2009, 02:19 PM
Sometimes, you have to tell someone they are asking the wrong question.

I agree, but that doesn't mean we can't also give them what they're asking for. Let's face it--people are often faced with unreasonable expectations, and have to do what they have to do in order to get along in their jobs.

Coury Ferguson
23rd March 2009, 04:06 PM
Can somebody help me out in writing corrective action (in the technical language) for the following received NCs:.....<snip>

I going to be blunt here: Do you really know what it takes to determine/perform Root Cause Analysis?

It almost seems that there might be a lack of knowledge by a lot of people. And why in the World would your QMS require Technical Language be used to respond to CA?

Marc
23rd March 2009, 04:34 PM
Maybe the OP wants to get a feel for how to properly reply to a request for corrective action.

I'm surprised at the 'problems' people are having with this thread.

Matt M
23rd March 2009, 05:31 PM
I just finished reading the thread and I think it was good of Sam to offer his help. I understand where some seem troubled by what they have read as to what is going on in the organization where Ashwini works. We all have reactions like this to things we can't imagine happening in our own microcosms. But we don't know the full story and it is hard to get by that sometimes and I know I've been guilty of it too. But to Jims' point, she asked for help and Sam responded. That is why I joined. I found a body of knowledge I could learn from and even more, that I could participate in. As far as the "technical language" again, we don't know what demands were placed on Ashwini for how they were to be written. I asked myself,why would she need to do that? I immediately thought of past events I have witnessed or worse,been involved in, where the criteria for how something needed to be done was a little beyond the requirement.
Just my thoughts:D

AndyN
23rd March 2009, 07:09 PM
Here's my concern, better described, I hope.

If we go back to the first post and extract one example:

Can somebody help me out in writing corrective action (in the technical language) for the following received NCs:

1. To define the controls for the outsourcing of warehousing facilities within the quality management system.

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.


I rather doubt that this is the real cause:

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.

Since this was found at a 'stage 1' audit, it shows there's an issue with the 'design' of the quality management system - the documented process and controls.

The 'root cause' must deal with why the system didn't define the controls over outsourcing the warehousing. Why wasn't it included? Is it new?

The requirement in the standard is clear, so why wasn't it included? When you have the answer, then you have 'root cause'. I don't see how the suggestion - a lack of review - is the real reason

Marc
23rd March 2009, 08:07 PM
I think this is probably more of a language issue than anything else. ashwinirane didn't put in his/her profile where s/he is from, but English may be a second language.

Andy, you just showed this can be more about the original post than getting into the 'aside' of whether people should reply or not.

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....... Are you wanting to scare people away from posting? There is an inherent danger in writing (and posting) any opinion, experience or other response here no matter what the topic.

Please - Only responses related to the posters question. All this controversy has done is totally derail this thread and, possibly, will deter some people from trying to help in other threads for fear of being chastized.