In my company, when there are Customer complaint - it is usually through email or phone call. At times, we will receive official CAR from customer & sometime we don't.
We have a KPI system where we record every customer complaint. But recently we begin to debate whether for those complaint that just comes in the form of email or phone call telling us this "A" product got problem & without any request for a CAR ... should this counted as a complaint & factored in the KPI ?
Also, is there a universal definition for Customer complaint as which is counted & what is not ?


thks

Hi goalout,

The ISO 13485:2003 has a nice definition of what is considered a customer complaint: Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance (of a medical device) that has been placed on the market.

Additionally, ISO 9000 mentions that "Customer Complaints are indicator of low Customer satisfaction" but their absence doesnot necessarily imply high Customer Satisfaction"

I would suggest you to maintain a Log for registering Customer Complaints, which has a column for mentioning the mode of communication. Thus, if you receive oral communication over telephone, it can be recorded in that log accordingly.

Complaints offer very good opportunity to correct immediate problems. In addition, they frequently provide constructive ideas for improving products, adapting marketing practices, upgrading services, or modifying promotional material and product information.

There is a saying - "There is nothing wrong in making a mistake but there is something wrong in not learning from it and making the necessary corrections".

So, go ahead and record the Customer Complaints.

Don't forget that each company is different, so what each company defines as a *valid* Customer Complaint is often different.

Marc,

Given the definition of ISO 13485, all oral, phone, email complaints are VALID, right ?

I give an example. Currently, I am on a business trip and am staying in a hotel. This morning, the room air conditioner was not working properly and the room turned stuffy. So I immediately went to the receptionist and lodged an oral complaint. She acted immediately and the room was okay.

This is like a 'QUALITY ISSUE" of the room conditions. Similarly, for my organisation, if the customer makes an oral complaint, I have to fully subscribe to his complaint. :yes:

Let's say you sell a blue widget and a customer calls and complains about the color not being red. It may be the customer expectation (for whatever reason) that the widget be red but if you advertise blue widgets the complaint is not valid.

My point is customers often complain about things that are not relevant to the product. These are not valid complaints.

I have a client who makes a commercial detergent that comes in 50 pound bags. A customer complained that the product did not 'foam up' enough. The foam is produced by a chemical that has nothing to do with cleaning. The chemical is put in because customers *expect* foam, but nowhere does my client state the product foams. They DO know, after making the stuff for over 50 years, that customers do expect some foam (just as many people who use hand soap of laundry soap *expect* some foam even if the foam has nothing to do with how well the product cleans. That complaint is rare, but when it does come in they classify it as an invalid complaint. How much foam is 'enough'? How much is too much?

These are simple examples. The point is to make sure you define what *valid* complaints are and what complaints are not valid. As to whether you log every complaint, valid or not, that's another issue.

By the way, there are a lot of customer complaint discussion threads here such as Customer Complaint - Definition of Customer Complaint (http://elsmar.com/Forums/showthread.php?t=4752) which you might want to read through. Try a Search.

Several Customer Complaint discussion threads (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=customer+complaint)

Thanks Marc. Yes, I do accept that its best left to the company to take the complaint as VALID or not.

However, the point which was given by goalout was -

But recently we begin to debate whether for those complaint that just comes in the form of email or phone call telling us this "A" product got problem & without any request for a CAR ... should this counted as a complaint & factored in the KPI ?

Thus I felt that he was enquiring about the mode of communication of Customer Complaints. In a good quality system, I would still accept the customer complaint and later assess if it is VALID or not. I shall give an example -

In my Pharmaceutical company, we receive complaints where the customer complaints that the strips are short of some tablets or some packs do not have tablet strips at all. I used to track all these complaints and found that most of the complaints originated from a single place. With these type of analysis, I could substantiate that these are not VALID. Additionally, I visited the distributors and retaliers in that area and showed them all my statistical analysis and graphs and also told them that their complaints are not genuine and may complaint to the authorities if they continue to do so. You know what, the complaints from that area got reduced.

Yup - I was just throwing in a bit of "think this through" info because I've seen so many companies that had not actually looked at the valid vs. invalid aspect.

Yes - you are right in how you answered.

Thanks Marc

Suggest you check ISO 10002:2004 Quality Management - Customer Satisfaction - Guidelines for Complaint Handling in Organizations. It is a good guidance document.

In that document, the definition of a complaint is:
expression of dissatisfaction made to an organization, related to it's products, or the complaint-handling process itself, where a response or resolution is explicitly or implicitly expected.Next October, I will give a presentation to the Orange County (CA) Chapter of ASQ about using ISO 10002 to handle complaint handling processes.

Sidney,

Do you have additional information on ISO 10002 ?

Thks all folk who reply mail. I really learn alot from different industry & examples. I like the suggestion that I should keep a log as to the mode of complaint & analyse it.
In my company again, when we write the CAR - my boss dislike the use of words "ongoing", " The probable cause might due to ........" , ... is due to operator neligence in detecting ....... - is there a anything wrong using these words ?

Thks

Sidney,

Do you have additional information on ISO 10002 ?Yes, I do.:rolleyes:

Thks all folk who reply mail. I really learn alot from different industry & examples. I like the suggestion that I should keep a log as to the mode of complaint & analyse it.
In my company again, when we write the CAR - my boss dislike the use of words "ongoing", " The probable cause might due to ........" , ... is due to operator neligence in detecting ....... - is there a anything wrong using these words ?

Thks

goalout,

I agree with your boss. May be, he is like me. :cool:

Have seen many companies do not perfrom a detailed investigation and put the blame (sorry for the harsh word) on the operator. Most times, its really not the operator but due to the faulty procedure which he is following or something to do with the machines which the Engineer is not able to find out.

This is similar to the doctor who says its a "Viral Infection" when he is not able to find the reason for fever :D

Do a detailed investigation using various tools like Fishbone Diagram, Brainstorming and then come with conclusion. If your conclusions do not prove fruitful, then you list your probable causes

Even in probable cases, I would like to see some monitoring with probable action items.

is due to operator neligence in detecting .......

You can use that once for a given 'error', but after that it's not going to be acceptable. See Operator Error (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=operator+error).

Generally speaking, I think that as a manufacturer one should consider and evaluate all complaints, valid or not. When a customer complains abouts something they are generally dissappointed, and it is always wise to get a clear picture of customer expectations. Even if the complaint is not valid it can provide input to the organisation regard opportunities for improvement. Thats pretty useful.

When evaluating complaints (and internal deviations) it is my belief that we should always try to find the cause of the disease, not the symptom. Is it training? Faulty instructions? Raw materials? Specifications? It is easy to just blame the operator, but it seldom provides serious improvement.

Just my :2cents:

Generally speaking, I think that as a manufacturer one should consider and evaluate all complaints, valid or not.

I agree, but the issue is where to go with it. For example, a commercial chemical powder blender supplies 100# bags of a specific chemical compound. The bags are 'normally' used in large operations so to make a mixture the customer is pouring in a certain number of bags rather than, for example, 1/4 of a bag. A Customer Complaint came in which was "The powder has lumps in it". The complaint was evaluated and judged to be invalid. Lumps do not affect the performance of the product (it is dissolved in water for use), nor is there any mention of the product being 'lump free'. It was also noted from the batch number that the product was manufactured and shipped over a year prior to the complaint. Over that year many things could have happened such as one or more bags being pierced at the customer facility while in stock (storage).

However, the company bought a 'Lump Buster' and started checking product for lumping after mixing. The product was accepted for return, although the complaint was judged to be 'technically' invalid. It was noted that in fact a number of the bags were pierced, however the product is moisture stable so it was run through the lump buster and repackaged.

The lump buster sits in the corner and has not been used in the several years since the complaint.

A company should always be looking for new ways to satisfy customers, but then again care should be taken as to how far they are willing to go. In this case the expenditure wasn't excessive, the customer was pleased and they now have a lump buster should they need one in the future. But - What if the 'solution' had been very expensive and/or time consuming to implement?

Secondarily, consideration should be given to the frequency of the complaint. The company in the situation described here had only 1 complaint about lumps in the product. The more complaints, the more important it is to look at the complaint, even if it is technically invalid, and relate it to customer expectations with consideration given to addressing the complaint.

As to "When evaluating complaints (and internal deviations) it is my belief that we should always try to find the cause of the disease, not the symptom. Is it training? Faulty instructions? Raw materials? Specifications? It is easy to just blame the operator, but it seldom provides serious improvement.", I agree. However this is mainly applicable to valid complaints / nonconformances. As to 'Operator Error', we all know that Operator Error is not an acceptable 'Root Cause' determination and root cause is what nonconformance investigations are about whether an internal nonconformance or a nonconformance identified by a customer.

As far as I am concerned, a complaint is a complaint, via email, phone, or CAR request.

The customer has identified a concern, therefore investigate the concern.

How about this ... I have 2 customer complaint recently.
Case A - the product was found to be manufactured 5 months ago. We have been supplying them every month. And out of the blue, we have this complaint which is 5 months old. How should react & write the CA. I think 5 months to inform us is a long time .... & we are supply them every month ...
What is the best way to handle this case ?

Case B - this customer email us that there is this XYZ qty found defective. When we asked which batch/lot - the customer just say ..."oh ... we cannot know because we accumulate over a few PO ... so cannot tell which is which ....
So, what is he best way to handle this case & write the CA ?
Thks

How about this ... I have 2 customer complaint recently.
Case A - the product was found to be manufactured 5 months ago. We have been supplying them every month. And out of the blue, we have this complaint which is 5 months old. How should react & write the CA. I think 5 months to inform us is a long time .... & we are supply them every month ...
What is the best way to handle this case ?

Case B - this customer email us that there is this XYZ qty found defective. When we asked which batch/lot - the customer just say ..."oh ... we cannot know because we accumulate over a few PO ... so cannot tell which is which ....
So, what is he best way to handle this case & write the CA ?
Thks

I've seen B I saw all too many times in the past. I hated that.
At least in my current job everything is date coded.
Generally the corrective action would be "replace the defective material" and the preventive action would be a very general "issue a quality alert for production and QC to be aware of an existing issue". And stipulate that we cannot get any more specific than that without lot information.

Case A I can't really give my response to as I don't know the industry or the part. In my business (pressure relief devices) our direct customers are often distributors so we may get a complaint a year old for parts that they buy every month. Nothing unusual about that.

How about this ... I have 2 customer complaint recently.
Case A - the product was found to be manufactured 5 months ago. We have been supplying them every month. And out of the blue, we have this complaint which is 5 months old. How should react & write the CA. I think 5 months to inform us is a long time .... & we are supply them every month ...
What is the best way to handle this case ?

It is still a complaint from the Customer (is it a warranty issue?). It should be investigated and if necessary initiate Corrective Action, in my opinion.

Case B - this customer email us that there is this XYZ qty found defective. When we asked which batch/lot - the customer just say ..."oh ... we cannot know because we accumulate over a few PO ... so cannot tell which is which ....
So, what is he best way to handle this case & write the CA ?
Thks

It still would require an investigation into the claim.

Question: Can product shipped be traced to a batch or lot number?

How about this ... I have 2 customer complaint recently.
Case A - the product was found to be manufactured 5 months ago. We have been supplying them every month. And out of the blue, we have this complaint which is 5 months old. How should react & write the CA. I think 5 months to inform us is a long time .... & we are supply them every month ...
What is the best way to handle this case ?

Case B - this customer email us that there is this XYZ qty found defective. When we asked which batch/lot - the customer just say ..."oh ... we cannot know because we accumulate over a few PO ... so cannot tell which is which ....
So, what is he best way to handle this case & write the CA ?
Thks

I think the best way to handle cases like these are to use them to initiate a dialogue with the customer regarding the way that they handle incoming goods inspection and the way that the handle product complaints. Explain to them that in order to give you the opportunity to improve and use the CAPA system you need timely and detailed feedback. Nobody benefits from complaints that cannot be acted upon.

Next October, I will give a presentation to the Orange County (CA) Chapter of ASQ about using ISO 10002 to handle complaint handling processes.A copy of my presentation to the ASQ chapter is attached.

very nice wish i could be there!!!!!!:thanx:

Impressive presentation Sidney. :thanks: I wish I could have been there.

(condensed version)... A Customer Complaint came in which was "The powder has lumps in it". The complaint was evaluated and judged to be invalid. ...
However, the company bought a 'Lump Buster' and started checking product for lumping after mixing. ...The lump buster sits in the corner and has not been used in the several years since the complaint.
A company should always be looking for new ways to satisfy customers, but then again care should be taken as to how far they are willing to go. ...
Secondarily, consideration should be given to the frequency of the complaint. The company in the situation described here had only 1 complaint about lumps in the product. The more complaints, the more important it is to look at the complaint, even if it is technically invalid, and relate it to customer expectations with consideration given to addressing the complaint.

As someone from the chemical industry, I can testify Marc's story is real world. I would be cautious about mixing up a complaint with corrective action. In Marc's story, the customer did have a complaint about the product but that does not necessarily mean that the problem was caused by the supplier. The root cause analysis indicated that the likely problem was caused by improper storage and handling of product for a long period of time with the potential for moisture problems. The proper corrective action should have been to discuss that information with the customer to ensure that they knew the proper methods for storing and handling the product. The wrong corrective action would have been to buy a lump buster. If more complaints of lumpy product are received and it can be traced to a process problem then that would be the time to investigate more expenditure.

In my opinion, and what we normally practiced, was that any communication from the customer regardless of how delivered about problems with the product or services related to it would be considered a complaint. As noted above, that does not mean that every complaint results in a process change but it does result in a cause analysis. Without treating the communication as a complaint, the cause analysis would be less likely to occur.

Bill Pflanz

Hooray for you Bill in recognizing the difference between a corrective action and a complaint! you definitely get the gold star.

A customer complaint is any negative feedback you receive from the customer, this can be about your product, your service, the color paint you have on your sign. Just because someone complains, doesn't mean that you are obligated to change the way you do business. It is all dependent upon the severity, the risks involved and the amount of return.

Hi every one,

i have a question, do you get certified for AS ISO10002 ?

Hi every one,

I have a question, do you get certified for AS ISO 10002 ?

No, this standard (http://www.saiglobal.com/shop/script/Details.asp?DocN=AS0733773117AT) includes guidelines, but can be utilized to develop processes for handling customer complaints in the context of ISO 9001:2000 or any other standard that applies to your quality management system.

Stijloor.

i have a question, do you get certified for AS ISO10002 ?No, this standard (http://www.saiglobal.com/shop/script/Details.asp?DocN=AS0733773117AT) includes guidelines, but can be utilized to develop processes for handling customer complaints in the context of ISO 9001:2000 or any other standard that applies to your quality management system.I wish it was that simple. ISO 10002 states it should not be used for certification purposes. However, a couple of CB's have issued certificates against that guidance document (copies of the certificates are available online). I covered this issue during the two webinars I ran on ISO 10002, earleir this year.

For more details on that discussion, see the ISO 10002:2004 implementation roadmap (http://elsmar.com/Forums/showthread.php?t=28032&highlight=10002) thread.

I totally agree with the Ajit . Marc is going bit different direction.
Definately compny need to difne what is complaint and almost 99% all companies agreed that complaints should be from any means could be by mail phone and email. It really doesnot matter. Thing that does matter is the nature of complaint. Based on the nature of complaint companies do have categories i.e.Minor, Major and crutical. So the complaint is evalusted based upon the this level and all complais must go in the your KPI sysem. If its a pharmaceutical system, which is heavily regulated, with no exception all complaints must be recorded and evaluated. Period.
It doesnot matter even it is of vey minor level i.e in Pharma Patches- some time donot stcik , its a complaint. broken tablet, one missing tablet.
Information on leaflet is not clear or missing or ambigious.

For you kind information March, People in North America complain for every single thing. I can give the example of my company without mentioning the name. We receive 100 complaints on monthle basis where as same company in Europe receive only 1/month.

Bottom line is , complaint is based on the nature of your industry but technically all complaints must be recorded .

Hi goalout,

The ISO 13485:2003 has a nice definition of what is considered a customer complaint: Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance (of a medical device) that has been placed on the market.

Additionally, ISO 9000 mentions that "Customer Complaints are indicator of low Customer satisfaction" but their absence doesnot necessarily imply high Customer Satisfaction"

I would suggest you to maintain a Log for registering Customer Complaints, which has a column for mentioning the mode of communication. Thus, if you receive oral communication over telephone, it can be recorded in that log accordingly.

Complaints offer very good opportunity to correct immediate problems. In addition, they frequently provide constructive ideas for improving products, adapting marketing practices, upgrading services, or modifying promotional material and product information.

There is a saying - "There is nothing wrong in making a mistake but there is something wrong in not learning from it and making the necessary corrections".

So, go ahead and record the Customer Complaints.

Ajit has a good 13485 definition which is in line with 21 CFR Part 820 (FDA Regs) definitions.
Complaint: means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it has been released for distribution.

It depends on what business you are in and, if it is defined for you in a standard or regulation.

Also, is there a universal definition for Customer complaint as which is counted & what is not ?

thks

We made up our own rules as to what requires a CAR, what defines a valid "complaint", etc., and how many occurrences in a period of time factor in too.