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DuckMan

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Posted 11 September 2013 - 07:55 PM

Hello all my friends!

 

This is a shout-out from DALLAS!

 

I am starting a new position with a Nutritional Supplement company here in Dallas Texas! Woo Hoo BIG D! That is right people, the city so awesome they named a soap opera after it! Sorry, I digress; my issue currently is attempting to put together a written procedure for addressing customer complaints. Most of the threads I have read on these forums have been very helpful, but the thing in this environment is that all the complaints are somewhat hard to investigate. Due to the nature of our products, we never get a complaint that is easily to verify like (physical contaminates, or things "concrete"), 99% of the complaints we receive are related to things such as (adverse reaction, allergic reaction, customer felt light headed, customer felt heartburn, customer felt head-ache). I have not seen a complaint listed in the log that required any type of medical treatment, complaints only describe an "unpleasant experience" or digestive reactions that seem to be randomly experienced by the individuals with no identifiable trends. Of course we keep samples of every lot that is sent out.

 

Previous threads I have read on the topic of customer complaints have stated that if the complaint was based on say "a physical contaminate like a sliver of glass or a hair or bug exoskeleton" and the customer could not or would not supply a picture or portion of the contaminate found, that the complaint would be ruled as uninvestigateable and therefore closed.

 

So my question I guess is this, with nothing supplied on these complaints other that the customers experience of "heartburn" what would I use to determine which complaint is investigateable and which is not and should be closed without further investigation.

 

Again, this is my first attempt to organize a system to address Customer Complaints so any suggestions or overview with this process yall could supply would be greatly appreciated. I have found the forums here to be a true oasis of information and expert knowledge, so thank you all in advance!

 

Sincerly,

 

Your Bro from another Mo,

 

 

The DuckMan



Moyers

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Posted 11 September 2013 - 09:16 PM

If your company produces Dietary Supplements, the procedure must comply with the cGMP regulations in Part 111 of 21CFR.  A customer complaint is defined as:

 

“… any communication that contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a dietary supplement, that could be related to current good manufacturing practice…”
 
This includes things such as off taste or odor that are not safety related necessarily.
 
A Qualified Person must  Review  and Investigate all product complaints to determine if the complaint involves  failure to meet specifications or any other requirement
 
Written procedures are needed to:
- Record every product complaint that is related to cGMPs
- Specify Name and Description of the dietary supplement
- Record Batch, Lot, or Unique Identifier Code of the dietary supplement, if known
- Record Date complaint was received and name, address, or telephone number of the complainant, if known
- Record Nature of the complaint including, if known, how the product was used.
- Retain your copy of the reply to the complainant, if any
- Record findings of the investigation and follow-up action
 
Good luck!


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Jus'me

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Posted 11 September 2013 - 09:50 PM

I understand your dilemma.  How can you investigate if you are not given definitive information to assist you.  I run into the same issue quite often.  A lot of times a complaint will come in and the nature of the complaint will just list "quality".  Great!  that really narrows it down!  What I would suggest is maybe building an excel sheet and logging all your complaints on that, using Moyers' list above especially including  the batch/lot number, nature of the complaint, date and so forth.  And then you can watch for trends.  If you start seeing where you are getting a number of complaints on a certain lot/batch, you can investigate this more thoroughly.  If the complaints are coming in more sporadically and are of a minor nature, "felt nauseous after consuming twenty of them", then you may not want to go too much into investigative mode, just keep it an open investigation.  Of course any serious adverse affect would have to be thoroughly investigated, but often times you will find it is not your product that is the culprit.  If you maintain good records though, and watch for trends, you should be okay.  I am not saying just list the complaint and forget about it, but prioritize what truly requires more attention and what can truly be investigated towards a resolution.   



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DuckMan

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Posted 11 September 2013 - 10:08 PM

Moyers, Jus'me,

 

Thank you both very much! Again I appreciate your time and information you have selflessly given to me. I wish you both the best profesionally and privately in all matters. 

 

Sincerly,

 

The DuckMan



Tony-C

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Posted 12 September 2013 - 01:20 AM

Agree with the comments made by Jus'me, you need to monitor your complaints and look for adverse trends. This could be by type/nature of complaint or a particular batch number.

 

PM for a complaint analyser template.

 

Regards,

 

Tony



Rizwan Ali

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Posted 12 September 2013 - 03:59 AM

You can check the retained samples of the same batch if you want to analyze to find the root cause.

You may make a list of probable causes for each complaint with the help of R&D and then investigate on it.



Charles.C

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Posted 12 September 2013 - 05:10 AM

Dear duckman,

 

Just  as a comment / illustration on yr OP.

 

If all the non-specific complaints you mention related to the same batch of  one product X (unmentioned) in a time period of, say, 1 month, you are probably safe in making an immediate memo to whomsoever you are reporting to of the form – “Houston, we may have a problem”.

On the other hand, if they cover a span of 5 years, the original recipient probably marked them all "resolved by Petersen" which i understand from watching US gangster movies is a polite synonym for the wastepaper bin. :smile:

 

The point is that every company has to set an action line which will relate to things like product, hazard frequency / severity, customer status. The specific choice is subjective, just like HACCP.  If you look back in this forum you will find some examples of tolerance rates employed for certain hazards.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


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Posted 12 September 2013 - 06:44 AM

Hello all my friends!

 

This is a shout-out from DALLAS!

 

I am starting a new position with a Nutritional Supplement company here in Dallas Texas! Woo Hoo BIG D! That is right people, the city so awesome they named a soap opera after it! Sorry, I digress; my issue currently is attempting to put together a written procedure for addressing customer complaints. Most of the threads I have read on these forums have been very helpful, but the thing in this environment is that all the complaints are somewhat hard to investigate. Due to the nature of our products, we never get a complaint that is easily to verify like (physical contaminates, or things "concrete"), 99% of the complaints we receive are related to things such as (adverse reaction, allergic reaction, customer felt light headed, customer felt heartburn, customer felt head-ache). I have not seen a complaint listed in the log that required any type of medical treatment, complaints only describe an "unpleasant experience" or digestive reactions that seem to be randomly experienced by the individuals with no identifiable trends. Of course we keep samples of every lot that is sent out.

 

Previous threads I have read on the topic of customer complaints have stated that if the complaint was based on say "a physical contaminate like a sliver of glass or a hair or bug exoskeleton" and the customer could not or would not supply a picture or portion of the contaminate found, that the complaint would be ruled as uninvestigateable and therefore closed.

 

So my question I guess is this, with nothing supplied on these complaints other that the customers experience of "heartburn" what would I use to determine which complaint is investigateable and which is not and should be closed without further investigation.

 

Again, this is my first attempt to organize a system to address Customer Complaints so any suggestions or overview with this process yall could supply would be greatly appreciated. I have found the forums here to be a true oasis of information and expert knowledge, so thank you all in advance!

 

Sincerly,

 

Your Bro from another Mo,

 

The DuckMan

 

Dear Duckman

Greetings

It seems it is necessary to consult with a qualified guy inorder to prepare detection matrix. It might help you to categorize complaints.



matheusdb

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Posted 15 January 2014 - 09:13 AM

:thumbup:



Yen Lee

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Posted 02 June 2018 - 03:34 AM

Anyone know is there any timeframe set to complete the customer complaint investigation and closure?



Tony-C

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Posted 02 June 2018 - 04:06 AM

Hi Yen Lee,

 
There is no absolute defined timeframe. I would suggest anything up to 2 weeks depending on the seriousness of the complaint and the level of investigation required. If I think that I can't respond quickly to a complaint then, out of courtesy, I would send a brief letter to the customer in the first few days acknowledging the complaint and stating you will write again once you have completed your investigation.
 
For example this is from BRC Guidance:
Investigation must be completed within a defined timeframe and feedback provided to the complainant wherever contact details are provided.
A rapid response would be required for serious issues such as a glass complaint, or where a number of complaints are received, suggesting a widespread problem.
Actions must be appropriate to the seriousness of the complaint.
 
Kind regards,
 
Tony

 





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