NCR/CAPA/CAR/CRN

Dear all,

I have now started at my new company and am trying to simplify the existing systems they have that have become stagnant.

At present we have one big system called the "Improvement Record Register". This is where all customer complaints, internal quality issues, supplier issues, internal audit findings, external audit findings etc. get logged. There is not a form for each, it is just one big spreadsheet that tries to capture everything but isn't!

At my last company I had forms and registers for;
Internal and supplier quality issues
Customer Complaints

And then what we called a CRN (Change Request Note) form/log. This was essentially a Corrective Action Form. Certain complaints and internal/supplier quality issues would be fed into this system if an investigation was deemed necessary along with any audit findings and suggestions by employees. This would call for the usual root cause analysis, corrective action and follow up etc.

I am struggling with which route to go down at my new company. Do I try to keep it all in one place or go with what I have tried and tested before?

 

Also, what do people call the form/log? Change Request? NCR? CAPA?

 

Change requests depend on the purpose. Design changes and mods would fall under ECR (engineering change requests) and would have a matrix since they are usually accompanied by revision level changes to the product. We log "customer complaints" under "Returns and Warranty work" where we decide if they are the result of NCM (nonconforming material) or some other cause (customer damage, shipping, etc). I have done away with CAPA forms completely as most people simply do not understand them, instead I may issue the an NCR and require an 8D or 5Y analysis or an FA (failure analysis) from a vendor, then get involved in a solution that would become a PA, working with that data and their team.

 

If you're trying to simplify, how does having multiple logs, registers and forms simplify anything? One global register is all that is necessary. If it isn't capturing everything, the question is why not? What they are doing makes perfect sense, and is something we have done for 20 years. If you where to walk in a suggest to me that we go to multiple logs and forms, after we have been there and done that, you probably wouldn't last too long.

 

Golfman - I understand what you are saying but the centralized system has not worked here.

Previously I have recorded details as below;

Customer Complaints - Nature of complaint, remedial action and associated costs on a complaint form and summarized in a master register with a link to the complaint folder which had the form, pertaining e-mails and photos etc.
Internal quality issues and supplier quality issues - Nature of issue, summary of investigation, associated costs recorded on a "reject form" and again summarized in a master register. If an investigation was required from the supplier, we would send them a supplier corrective action request for their completion.
Corrective Action Register - Inputs from complaints, internal and supplier quality issues, audit findings and 3rd party audit findings recorded on a form along with details of root cause and corrective action taken, the results of follow up review and close out. Summarised in a master register.

This worked but I know it was an over complicated way of doing things. I can see the benefits of having a centralized system but am struggling to see how it would work and capture all details, findings and costs etc. without any additional forms or registers???

 

Every one of your situations has the same basic components. They all start with a problem or issue. They all have some investigation or rca. And they all have some correction or corrective action. They could all be logged in the same log and all use a standard 8d type form or process to resolve. But you still haven't identified why a single system wasn't working and why three systems would?

 

Thanks guys, like I say...I understand the benefit of one register for all, just am struggling as to how to capture everything in that one log!

Does anyone have an example that I could look at as well as a form that forms the input?

 

Okay that's great thanks Roxanne.

I am still struggling a little as to how the information is reported to me to then record in the centralized register.

Let's say for example our factory identify some non-conforming material, how do they report this to me? Previously I have used a "reject note" which they fill out then pass a copy to me and a copy to quarantine.
And for customer complaints, the complaint would come in by phone/email and the details captured on a complaint form.

 

I will be the person entering the information into the log and then raising and assigning the form to the relevant person to investigate and resolve.

My question is, how does the information come to me. In the past, the issues were reported to me on a "reject form" or on a customer complaint form. I would then record that information into the log and raise the CAR.

 

But that would then require an independent reject note or customer complaint form, which then forms the input to the IR (Improvement Record) Log which then outputs IR forms for investigation and corrective action?

 

I would be less concerned on how the issue gets raised to you, and more concerned that it does. It can be a form, an email, a call, a napkin. As simple "issue" form could do the trick. Ask your people what they would prefer.

 

I'm starting to get it...I think;

1. One log to can capture all issues.

2. One form that allows the reporting and provides the input information PLUS captures the investigation findings, corrective action, verification etc.

One log, one form!

Process;
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Report form comes to me, I record the details in the log, then issue the form (now with unique # from log and any other details) to the relevant departmental manager for action...

 

Hello everyone I'm new to the forum, and what made me decide to join the forum is an external auditor had mentioned something during the 7th External audit during the end of last year. First of all I am a general contractor and owner of the business, and I am active in the implementation of the QMS as well and during audits.

Prior to the latest audit I had mad a single CAR form with a tick box for selecting if the CAR was for NC's, Internal Audits, External Audit, Customer Compplaints and Others. The others tick box is intended for certain situations that may or may not be part of the QMS yet, but may be included in the future. The single form contains the ff:
-Source of CAR
-Details
-Correction
-Corrective Action
-Concerned personnel
-Concerned Department
-CAR Status
-Follow ups
-Root Cause Analysis
-The form details like signatures, dates, control numbers, etc

Now back to the external audit, the auditor had mentioned that why is this just one form? so I said I had wanted to simplify things by not having a bunch of forms like we had during 9001:2008. but she suggested that it would be better to still seperate all the form that are found in the tick boxes, saying that it would help be in the record keeping an filing and organization. So I said what if I use the same form format and change the form title to their respective sources and then just havea different control number for each just so people will always be familliar with the format except it would have a different title and control number at least they wouldnt have to refamilliarize themselves again with the forms.

Well she didn't like my idea so i think he kind of smirked about what I said and then we moved on to the next topic of the audit, basically I want to know what am I doing wrong with the form because i honestly dont think i am wrong with the form, If I am then I would like a different set of eyes explain to me why, any help is appreciated and thanks in advance.

 

My thoughts are. One register and as few forms as possible. Once you have 'Quality' forms you are on a down hill slope. They are business forms and lets make quality part of the core business and not something tacked onto the side.

Today, I had a great conversation with the owner of the business I am working for. He said I really do not care if we get ISO9001. What I want is a system that helps us deliver the best product we can.