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NCR/CAPA/CAR/CRN

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jamescrockford, Mar 15, 2018.

  1. jamescrockford

    jamescrockford Active Member

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    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?
     
  2. jamescrockford

    jamescrockford Active Member

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

    hogheavenfarm Well-Known Member

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    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.
     
  4. Golfman25

    Golfman25 Well-Known Member

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    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.
     
    judegu likes this.
  5. jamescrockford

    jamescrockford Active Member

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    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???
     
  6. Golfman25

    Golfman25 Well-Known Member

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    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?
     
  7. RoxaneB

    RoxaneB Moderator Staff Member

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    The centralized systematic approach may not have worked because of issues beyond the tool itself (e.g., culture, accessibility, training/awareness, no one thought anyone was looking at it, etc.).

    My own take is to keep one system for all.

    One Register to document them all, One Register to analyze them,
    One Register to collate them all and in the Management Review advise them.


    By keeping it as close to one-stop-shopping as you can, this has the capability to provide some amazing analysis. Separate logs and tools mean when you analyze Customer Complaints, you only see trends there...and when you analyze internal quality issues, you only see trends with those...and so on. Put it all together and now you have the ability to see some truly systematic performance.

    You admit that you're new to the organization, so, be humble and ask folks there what's up with the lack of usage. Find out the WHY before you change the HOW.
     
    judegu and MichaelF_BMS like this.
  8. jamescrockford

    jamescrockford Active Member

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    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?
     
  9. RoxaneB

    RoxaneB Moderator Staff Member

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    While I do not have an example accessible to me at the moment, the log and the form are nearly identical in fields (my own preference) except for the fields that have all the copious details - that stays on the form. Again, being new to your organization, I think that this very topic is what you can have with the relevant stakeholders...find out what information is useful to them and from that create the form and register.

    That said, my personal preference is that the register/log pull in the information that can be useful for analysis purposes. It is impacted by the industry/field that your organization is in, however, for starters, I like:
    • Unique ID (YY-#### - eg. 18-0036 indicates that it is the 36th item recorded in 2018)
    • Event Source - Customer Complaint, Internal Audit Finding, External Audit Finding, Internal Quality Issue, External Quality Issue, etc. (your documentation to support this process would include definitions or detailed information explaining each of these types)
    • Issuer/Originator - Name of person
    • Issue/Originator Contact Information
    • Date of Issue
    • Due Date of Response
    • Event Category - Process, Product, System, etc.
    • Department Responsible - Which team/process is response for resolving the issue
    • Root Cause Analysis Required (Y/N) - determine criteria for when RCA is required
    From there, your form can have sections for corrections, root cause analysis (to be completed only if required), action plans, verification/validation results.
     
  10. jamescrockford

    jamescrockford Active Member

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    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.
     
  11. RoxaneB

    RoxaneB Moderator Staff Member

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    It really depends on the resources (i.e., manpower and money) of the organization.

    There is software out there that allows people to enter things into the system themselves and the log/register is created - I'm currently in a national healthcare organization; our employees, across the country can enter in various incidents from client falls to missed care to client feedback, all in one system, and it creates the reports that we use as part of our analysis.

    Or, if it's paper-based, then you'll probably need a centralized individual/team responsible for entering information to that log/register.
     
  12. jamescrockford

    jamescrockford Active Member

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    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.
     
  13. RoxaneB

    RoxaneB Moderator Staff Member

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    If your organization's system is paper-based, then it sounds as if that's how it will be done. If there was an e-form to be used, it could emailed to you.
     
  14. jamescrockford

    jamescrockford Active Member

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    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?
     
  15. RoxaneB

    RoxaneB Moderator Staff Member

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    The form may be the basis upon which the log/register is populated, but the form can still be common regardless if it is used by the source for a complaint, quality issue, audit finding, etc.
     
  16. Golfman25

    Golfman25 Well-Known Member

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    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.
     
  17. jamescrockford

    jamescrockford Active Member

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    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;
    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...
     
    Last edited by a moderator: Mar 20, 2018
  18. James D.

    James D. New Member

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    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.
     
  19. RoxaneB

    RoxaneB Moderator Staff Member

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    Hello, James, and welcome!

    Personally, I'm a fan of integrating the tools wherever possible. This promotes a common business language and culture. An N/C is an N/C, regardless if it is related to Quality or Safety or Environment or whatever set of standards you wish to apply. I'm not quite sure what your external auditor was attempting to achieve by making such a recommendation, but if all your data/information is together, that gives you a more holistic view of any trends, patterns, issues within your organization and processes. I'd even argue that that alone adds more value than the external auditor's stance regarding convenient record keeping and filing.

    If if it works for your organization and adds value and meets all the requirements, your external auditor should not have made that suggestion.

    That being, if you're looking for suggestions on the form, I'd offer that the 'tick box' you refer to could be set up differently. Nonconformances can occur as findings withing the audit - an n/c is simply a deviation from the expected norm/result. In my previous position, we said something was an N/C plain and simple. Now some N/C's were, for lack of a better word, "minors" (going old-school with that term, I know) and only required a correction. We had a matrix that defined our triggers for a minor - something that only needed a quick fix to get things back on track. It was a tiny hiccough that was low risk, low impact. For the "majors" - also on that matrix - we defined what would required a corrective action (i.e., root cause analysis, action plans, etc.). This higher risk, higher impact situations needed a more structured approach to reduce the likelihood of recurrence.

    Our form also included a Type of N/C - Quality, Safety, Environment, Finance, Other (please specify) section.

    And then there was a section for Category/Source that included items such as (but not limited to):
    • Audit - External
    • Audit - Internal
    • Product - Customer/External Complaint
    • Product - Internal Detetection
    • Process - Electrical
    • Process - Mechanical
    • Process - Operational
    • Spill/Emission
    • ... you hopefully get the idea ...
    And then there was, of course, the section for Department

    We had a tracking sheet that would allow to analyze the data using pivot tables. This helped us identify trends and areas that required a bit more attention.
     
  20. Graham Thorpe

    Graham Thorpe Member

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    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.
     
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