Feedback Needed: Customer Corrective Action Requests - CPAR or not to CPAR!

[Bridget]

Hello,
We sell our products to customers who are ISO, FDA and MDD compliant. I would like some feedback on what others are doing about corrective actions that are received from a customer.
When I receive a corrective action should this also create an internal corrective action for my company or is closing and responding to them on their form is enough?
Their CAR is not documented on my CAR log but is always kept in the same file as the ones that I write.
Thanks for a great forum,
Bridget

 

[Aaron Lupo]

Hello,
We sell our products to customers who are ISO, FDA and MDD compliant. I would like some feedback on what others are doing about corrective actions that are received from a customer.
When I receive a corrective action should this also create an internal corrective action for my company or is closing and responding to them on their form is enough?
Their CAR is not documented on my CAR log but is always kept in the same file as the ones that I write.
Thanks for a great forum,
Bridget

Bridget-

Welcome to the Cove.

What you are describing above is a Complaint and should be handled as such (820.198 of the GMP's). Now as the whether you have a seperate log or use the same one is up to you. I have no prefrence either way and the Company i work for has gone back and forth on this a few times. What really matters is that you are tracking, responding, correcting and analyzing them to improve your system.

 

[Tom W]

Hello and welcome to the Cove!

As I see it, you would want to first and foremost correct the problem on the customer CAR. How you do this is up to you and your established system. The improtant issue is to eliminate the problem and ensure that it does not happen again. This can be easier said than done, but it is what your customer(s) want and internally it is good for buisness.

As ISO Guy said it is up to you how you address the CAR, but you will want to ensure that you have records of how you addressed it so you can show the customer when they ask the next time about it. If the issue is a serious one I would definately initiate something internally to ensure that the problem is corrected and eliminated throughout the entire system. You have to weight the severity of the CAR and ensure that you respond / act accordingly. Hope this helps.

 

[RoxaneB]

What Tom and ISO have suggested are good food-for-thought, Bridget. We maintain Customer Complaints separate from our internal issues, but they follow very similar processes for resolution. Everything from a quick wham-bam-let's-get-back-to-making-steel for minor issues to full root cause analysis, action plans and verification plans for those requiring more attention.

Pick the system that works best for you. But, a note, select a system that will allow for easy analysis, too. If you have Customers that have repeat complaints, that's something you will wish to be able to spot quickly. If you have a particular product that generates multiple complaints, again, something you will wish to spot quickly.

Good luck!

 

[Wes Bucey]

What Tom and ISO have suggested are good food-for-thought, Bridget. We maintain Customer Complaints separate from our internal issues, but they follow very similar processes for resolution. Everything from a quick wham-bam-let's-get-back-to-making-steel for minor issues to full root cause analysis, action plans and verification plans for those requiring more attention.

Pick the system that works best for you. But, a note, select a system that will allow for easy analysis, too. If you have Customers that have repeat complaints, that's something you will wish to be able to spot quickly. If you have a particular product that generates multiple complaints, again, something you will wish to spot quickly.

Good luck!

I think you need to consider a minimum of TWO things when you receive a CAR from a customer:
1) Is this actually a request for corrective action on your process or merely a complaint for a "glitch?"
2) Is the CAR pertinent to the same product for different customers or to diffent products you make for one or more customers?

The point I'm trying to make is you "ought to" [not "must"] have a methodology in place to distinguish when a customer "complaint" (regardless of whether THEY call it a CAR) requires a systemic or process change by your organization. If so, it ought to also be "an internal corrective action."

If it is merely replacing a damaged part or missing paperwork which was a one-time event, then just deal with it and leave it in the customer file.

Here's one additional tip: IF you "know" there is a possibility of generating a customer complaint or CAR (late delivery, missing certs, etc.), be proactive and tell the customer in advance and there is a high probability you can avert a CAR if you tell them the truth, "The delivery will be 2 days late because we had a machine breakdown which delayed labeling. We have fixed it and do not anticipate future delays."

The key being you have recognized and cured the problem internally and you care enough about your customer to keep them informed.

Welcome to the Cove.

 

[tomvehoski]

I have used several of the methods mentioned above in the past. Probably the most effective I had was raising an internal CAR any time a customer complaint came in, regardless of the format of the report (customer CAR form, our problem report form, phone call, bar napkin from sales, etc.). Reasons:

1. I used an Access database for tracking. Each CAR was labeled with origin (internal, customer, etc.) for easy sorting and analysis. This ensured a customer CAR did not get lost in the system by not being logged into the database.

2. By issuing an internal CAR, the teams only had to learn one method for completing the assignment. There was less confusion about the customer step 2 equaling our step 4. If the customer needed their form completed, I would do so at the end of the process and submit it, usually with our form attached.

Hope this helps.

 

[Wes Bucey]

I have used several of the methods mentioned above in the past. Probably the most effective I had was raising an internal CAR any time a customer complaint came in, regardless of the format of the report (customer CAR form, our problem report form, phone call, bar napkin from sales, etc.). Reasons:

1. I used an Access database for tracking. Each CAR was labeled with origin (internal, customer, etc.) for easy sorting and analysis. This ensured a customer CAR did not get lost in the system by not being logged into the database.

2. By issuing an internal CAR, the teams only had to learn one method for completing the assignment. There was less confusion about the customer step 2 equaling our step 4. If the customer needed their form completed, I would do so at the end of the process and submit it, usually with our form attached.

Hope this helps.

In 2002, we had ONE CAR. It was a beaut. It took one month to resolve with involvement by two of our suppliers, two instrument manufacturers, one independent test laboratory, customer's quality staff, me, and my quality staff.

In 2003, we had no CAR. Therein lies the spectrum of whether or not an organization has to create a database to keep track of CAR or not. I'm not sure how I would feel if I were in an organization which dealt with large numbers of CARs (enough to maintain a database.) I think I might feel as if we had failed mightily in the preventive action activity.

In our case we didn't need a database beyond the thick file folder detailing the actions and results surrounding the root cause analysis and corrective and preventive measures instituted. I am so thankful we found and resolved the problem before the product was installed on a plane, regardless of the fact there was only one chance in millions of all conditions being present for the product to fail during its projected life. Even failure would not have been a life, health, safety issue, but it would have been a nasty public relations issue.

 

[nodakbil]

When dealing with Customer's input, I have broken this down and called it "Feedback". Feedback can be rated as positive, neutral, or negative. This is set up in a stand alone database, but a negative feedback has the option of generating a CAR in the CAR database.

These options allow me to search the database separately when performing customer satisfaction reports, customer complaint reports for non-technical or product satisfaction issues, and customer complaint reports which require action be taken to resolve an issue. It provides a very useful tool for CII reporting, as the positive results are also recorded. It has also proved useful to our Marketing Dept. when a neutral report is taken, as they are informed that a customer may be "walking the wire" with our services and extra attention may be given to pull them over.

 

[Bridget]

Thanks to all

All of you have given me some very sound advice. We do track returns and complaints but unfortunately have to satisfy my notified bodys quota for CPAR's!!!

I did log this as a complaint also and I thought a CPAR would be duplicating paperwork.

Thanks again,
Bridget