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Corrective and Preventative Actions

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Glenn0004, Jan 27, 2016.

  1. Glenn0004

    Glenn0004 Member

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    In a simplistic word we have available a documented process for Corrective and Preventative Actions, Person A raises and submits an action, its registered and passed to an owner; the owner reviews, actions and submits the action for closure (simplistic view). Most of our actions come from internal audits not ad-hoc incidents or process failure.

    I'm looking at ways to encourage and implement Corrective and Preventative actions and root cause analysis.

    Would it deemed acceptable (in addition to the above) to document the arrangements for the monitoring and measurement of a process and include requirements for identifying the root cause and required actions of any KPI failure or failure identified in the monitoring and measurement.

    I.e. we have contract set-up process and we monitor the number of credits raised as a result of errors within contract set-up. If we took the credits and errors within the contract set-up to a root cause and required actions, would this be acceptable under the requirements for corrective and preventative actions.
     
  2. Bev D

    Bev D Moderator Staff Member

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    absolutely. corrective action should not be limited to audit non-conformities. in fact these should be only a small portion of your CA system. CA should be initiated for situations that produce product or service defects/failures.
     
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  3. RoxaneB

    RoxaneB Moderator Staff Member

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    To echo Bev, it would be totally acceptable! I encourage a system that aims to use one system for addressing (potential) failures. In my previous experience, we created a log where we indicated the nonconformance "type" or "source" - this helped with analysis and focusing in on our top pain points. Type/Source options included - Internal Audit, External Audit, Process, Product, Quality, Environment, H&S, Metric, Other...and probably a few more.
     
  4. Nick1

    Nick1 Member

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    I agree with the previous answers, it is good practice to file every single non conformity. The non conformity reports are the single most important input for a continuous improving company. Everything which didn't go as it should have to be filed as an NCR and investigated properly including a root cause analysis.

    Determining when the employees should create an NCR can be tricky though. I wrote an article about that. You can check it out here:

    http://blog.qooling.com/the-non-conformance-report-when-to-create-one/

    Good Luck
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    Filing every single occurrence of a nonconformance can result in the system exploding with an abundance of paperwork and red tape and bureaucracy and action plan implementation burnout. The end result could be that, while intentions were good with the creation of one system, the overall nonconformance system just ceases to be used at all.

    Can you imagine if you were given a speeding ticket every time you did 105 km/hr in a 100 km/hr zone? Or 65 mph in a 60 mph zone? It's an obvious nonconformance - failure to follow procedure based on your article Nick - but the backlog in the judicial system and payment systems would be quite extreme.

    This is where having access to reliable data can come in handy. Develop triggers for what is entered into the nonconformance system. For example:

    • Quality Complaints - All externally sourced quality issues
    • Internal / External Audit Findings - All audit findings, regardless of source (or initiator)
    • Safety - All safety violations
    • Process - ...this is where it gets fun with the data! :)
    Let's say you have a nice, simple manufacturing process that goes from Equipment A to Equipment B to Equipment C to the Warehouse. An analysis of the process indicates that delays frequently occur between A and B and C, resulting in crane operators either having nothing to do (i.e., waiting, one of the wastes that Lean attempts to get rid of) or rushing around to place inventory properly. To write up a nonconformance for every delay might not be practical. Look at the delays and understand the reasons behind them AND how long they last. Focus on the top hitters - I can't say top 3 or 5 or 20% because it really all depends on your resources. After this analysis, you may decide that any delays caused by mechanical failure and any delays greater than 20 minutes warrant corrective action.

    Remember I mentioned the idle-rushing extremes for the crane operators in the warehouse? If their rushing to place inventory results in improperly placed items and a delay in locating, we have another possible nonconformance trigger. So now we have three process-based nonconformances that we're going to focus on.

    Focusing on these delays may result in (a) fewer overall delays AND (b) a more even workload for your crane operators in the warehouse.

    We took such an approach to our process-based nonconformances in a previous job. We would review the triggers on an annual basis. If we did proper root cause and took proper actions, there was a decrease in the occurrence of these "heavy hitters" and we would focus on the next top items for the following year and/or tighten up our triggers. Instead of delays greater than 20 minutes, if our analysis showed that we had worked the average down to 17 minutes, we'd set a trigger of 15 minutes.

    I hope this makes some sense. In an ideal world where organizations have time and people to track every single hiccough, I would love to see each and every nonconformance documented for a more thorough analysis. Unfortunately, the modern organization is running quite lean on resources and time, while juggling multiple priorities. We need to be careful and considerate when attempting to develop sustainable management systems.
     
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  6. Padym

    Padym Active Member

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    Hi All, Can somebody throw some light on how this works in a typical Managed IT Services industry. Service industry which is more inclined to provide warranty support services, which inherently as agreed with the customer to deal with non-conformance (downtime, service interruptions, service request, change, incidents). Not sure if these events can be called as non-conformance in first place. In an IT enviornment these are bound to happen.
     
  7. RoxaneB

    RoxaneB Moderator Staff Member

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    You can log every type of customer-based nonconformance but perhaps elect to only apply corrective action to the significant items. Data analysis is required to identify what is "significant." It could downtime > 5 hours or service interruption to select customers or, well, who knows what the data could show.

    But logging each incoming customer request is probably important to your field to understand volumes. Then you can say you field 100 calls a day, with 10 of them being "significant" and warranting further corrective action. The remaining 90 were resolved on the spot.
     
  8. Leonid

    Leonid Well-Known Member

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    Fully acceptable since this is the implementation of 8.2.3 Monitoring and measurement of processes "The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate".
     
    Last edited by a moderator: Feb 6, 2016
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The use of the management system is, in fact, supposed to do this: Preventive in nature, if you operate a systematic approach to planning and implementation, your organization should prevent issues. I can vouch for this as I ran (as the Quality Manager) a $2M NATO (1984 money) contract (to NATO AQAP-1) with 9 people - all QMS novices - and we had zero failures in designing, building, testing, delivering, installing and commissioning 33 machines across Europe.
     
  10. Leonid

    Leonid Well-Known Member

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    I do full agree with that. There is saying that QMS as such is the set of preventive actions except the element "corrective action". If so, these system preventive actions address risks (that is potential NC) by default.
     

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