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Clause 10:Demonstrate Continual Improvement

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by mohamed raazith, May 9, 2017.

  1. mohamed raazith

    mohamed raazith Member

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    dear all

    According to ISO 9001:2015 tools and methodologies needs to demonstrate continual improvement.
    Please explain regarding to the tool and methodologies

    Is floe chart is enough or else what are the tools and methodologies is best one to demodtrate the continual improvement of an organisation
     
  2. tony s

    tony s Well-Known Member

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    Can you specifically quote the exact statement in ISO 9001:2015 that requires "tools and methodologies"? I'm reading my copy of the standard and I can't find any statement about this.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    While ISO 9001 does require CI (but not tools etc to be defined) there are many (classical) ways to improve: http://asq.org/learn-about-quality/continuous-improvement/overview/overview.html
     
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  4. mohamed raazith

    mohamed raazith Member

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    Organizations will now need to demonstrate that they are using the output from their analysis and evaluation processes to identify areas of underperformance and opportunities for improvement

    Appropriate tools and methodologies should be employed by the organization to support the activity.

    These is transition guidelines given by our certification body(who giving ISO certification to us)
    I also seen the ISO copy but there is no Statement like these.
    what can i do now? i am totally confused know please help me
     
  5. tony s

    tony s Well-Known Member

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    In Clause 10.1 there is a NOTE providing examples of improvement such as "correction, corrective action, continual improvement, breakthrough change, innovation and re-organization". Organizations can utilize specific methods to help them improve their QMS. These can include:
    • internal audit (9.2),
    • management review (9.3),
    • procedure for correction and corrective action (10.2),
    • establishing objectives (6.2),
    • analyzing and evaluating appropriate data and information (9.1.3)
    In analyzing and evaluating appropriate data and information there are various tools or methods an organization may adopt. Although not a requirement, organizations may utilize tools and methods that include, but not limited to:
    • statistical techniques (control charts, capability analysis, anova, etc.),
    • pareto chart, histogram, checksheets, scatter diagram,
    • cause analysis tools/techniques (brainstorming, asking why analysis, fishbone analysis, etc.)
    • surveys, feedback analysis,
    • fmea, swot, pestle, haccp,
    • supplier performance rating,
    • flowcharts, and many others...
     
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  6. mohamed raazith

    mohamed raazith Member

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    thanks now i got a clear clarification
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Are you ISO 9001:2008 already? It is not a "new" requirement to do improvement, if you are already ISO 9001:2008 compliant. Can you confirm?
     
  8. mohamed raazith

    mohamed raazith Member

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    we are having ISO 9001:2008 already..
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Then you had to implement CI already. Nothing's changed here...
     
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  10. Daniel Padilla T

    Daniel Padilla T Member

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    Hi Tony, Can you give me an example of the difference between breakthrough change and innovation?
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    While Tony rests, I can! Breakthrough might come from a Six Sigma project, or implementing a LEAN (TPS) methodology. Innovation can come from small scale improvement workshops like Kaizen, Quality Circles. There's often components of both in each method adopted, in some cases. (Kaizen is part of TPS). ISO 9001 recognizes that either can be adopted, depending on the organization's needs.
     
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  12. Richard Billings

    Richard Billings Active Member

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    Identify process weaknesses, and determine what needs to be done to improve a spefic process. Assign an owner, determine the time-line for completion and monitor the project. In our company each Manager, including Top Management, must identify a CI project as one of their annual objectives.
     
  13. RoxaneB

    RoxaneB Moderator Staff Member

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    Building upon Andy's thoughts to this, I also look at breakthrough change and innovation as a completely new/novel way of doing things.

    For example, my organization focuses on in-home health care. When someone is discharged from the hospital, but still requires some form of care, support, therapy, we're the ones that go into their homes. For us, an example of 'breakthrough change and innovation' came through recognizing that it's not just the patient who needs our care and support, but also the care giver (e.g., spouse, adult child, loved ones). We developed a brand new product line dedicated to these amazing people who care for their family members, while trying to hold down a job, maybe even raise their own family. We recognized an unserviced demographic.

    Or maybe it's a new change to your organization in communication. In an organization I worked for previously, it was a big step forward for us to implement a system that showed all organization projects and metrics, and how they tied in to each other. We demonstrated how each project aligned with objectives and contributed to overall targets - results and activities were connected from a team level up to the highest organizational level, allowing us to show how even the smallest team at our smallest location contributed to the overall organizational performance.

    Or maybe it's a new way of showing process performance - In the organization I just spoke about, we added a simple visual indicator - viewable anywhere along the line - to show the status of the product (in this case, steel) as it rolled down the line. This way, we didn't just rely on visual observation of a problem and trust operators to use their radios to ask the first step operators to hold the line. They could see from the board that there was a problem and hold up on sending any more product down the line, before any thing came over the radio. The radio was, however, still used as a secondary confirmation of a problem. This reduced our product waste and improved process output.
     
  14. RoxaneB

    RoxaneB Moderator Staff Member

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    The company where I work now has a group called Futurists. Their role is to network outside of the organization and identify trends and innovation - and consider how to bring such concepts internal to us.

    However, if you're looking for some ideas that are a little more affordable, in my previous company we had a formally defined problem solving process. It was up to our operators to identify problems and form teams to solve them - supported by a facilitator who specialized in the problem-solving process and our software for capturing the results of step of the process. The idea was for solutions to be low cost and low tech.

    We had competitions each year at each of our sites, with the winner going to our national problem solving competition. The top three from each national level went on to compete in our global, organization-wide, competition.

    Each presentation went into an online "library" so that that sites could see what other problems had been solved. This was done to avoid sites starting from the very beginning of solving a problem, when another site might have already solved a similar issue.
     
  15. tony s

    tony s Well-Known Member

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    Daniel, you're very fortunate that I wasn't around when you asked this question. Honestly, I'll just copy what Andy and Roxane have shared to us.
     
  16. Daniel Padilla T

    Daniel Padilla T Member

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    Thank you all guys!
     
  17. Richard Billings

    Richard Billings Active Member

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    Breakthrough Change and/or Innovation? You guys are making this more difficult than it really is. Why not just focus on the Risks and Opportunities that have been identified because continuous improvement us required for both.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I don't believe that's correct. The question is NOT what to work on, but HOW.
     
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  19. tony s

    tony s Well-Known Member

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    Daniel is asking about examples of the differences between breakthrough change and innovation. Andy and Roxane provided helpful answers. I, just copied them. Can you share your answer?
     
  20. BufferMess

    BufferMess Member

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    Sorry but breakthrough change and innovation is not what ISO9001 actually requires with Continual Improvement. Continual Improvement is not requiring you to select a model for developing a business. It is actually a behaviour or approach for improving the QMS of organisation. The standard requires you to take incremental steps when improving the system. You should have smaller PDCA cycles implemented to QMS activities like, resource management, operations, purchase activities, objectives, control of nonconforming outputs, training etc. The standard requires to periodically evaluate suitability, adequacy and effectiveness of these actions. Every step you take should return a more efficient QMS. KPIs are crucial for Continual Improvement. You should develop an approach for selecting, monitoring and evaluating KPIs in long term. Changing the KPIs frequently will create chaos and you'll fail in evaluating long term success.

    - the QMS must have KPIs for long term evaluation
    - the QMS must be more efficient than it was in the past year
    - the QMS must be improved in a stable and consistent way

    Some companies use tools like Quality Circles or Kaizen for process improvement. This type of improvement is more suitable to the QMS as it is a process based system and Kaizen groups are typically formed of persons who do similar work.
     

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