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KPI for Quality assurance

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Rajan Gupta, Nov 3, 2017.

  1. Rajan Gupta

    Rajan Gupta Member

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    Just help me to figure out what all could be the KPI for Quality assurance department apart from ISO certification and managing non conformities
     
  2. tony s

    tony s Well-Known Member

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    When you say Quality Assurance department (QAD), does that mean a team of people who takes the lead role in planning and implementation of your QMS? Since KPIs are "measurements of performance", you can determine them relevant to the QAD's processes. Example:
    QAD Process: Internal Audit
    KPI: % of on-time audit reports; number of OFIs adopted;
    QAD Process: Document Control
    KPI: cases of obsolete documents found at point of use;​
     
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  3. Rajan Gupta

    Rajan Gupta Member

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    Thanks for your input Tony
    I mean to say the KPI for Quality assurance function
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Departments or functions don't have KPIs which are meaningful. QA is there to provide an independent verification for management - that's what "assurance" means. You are a service function. You provide feedback that the various processes of an organization are functioning as planned. Measuring QA is a fruitless activity when there are going to be far more important issues to work on - take a look at section 4 of ISO 9001:2015.
     
  5. Rajan Gupta

    Rajan Gupta Member

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    Thank Andy for the reply
     
  6. normzone

    normzone Well-Known Member

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    Yeah, I've been down this road before. [Andy Nichols] sums it up well. There is little that the department does that they have direct control over, or can positively affect the performance of, so the pressure to choose some cute but meaningless KPI is real.
     
  7. tony s

    tony s Well-Known Member

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    My approach is like this. If clause 6.2.1 requires "The organization shall establish quality objectives at relevant functions, levels and processes ...", then I will be obliged to set quality objectives for relevant functions such as QA or on its processes.

    If 6.2.1b requires that quality objectives must "be measurable" and must "be monitored" (see also 6.2.1e), then I will need to determine appropriate "performance metrics or performance indicators" to be able to satisfy both requirements and, more importantly, determine the condition and status of the function or its processes in achieving the set objective/s.

    If clause 4.4.1c requires organization to "determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes", then I can make use of the performance indicators to support the set quality objective/s for a particular function or its processes.

    Terminologies and their definition that you can use for references:
    Performance - measurable result (3.7.8 of ISO 9000:2015);
    Indicator - measurable representation of the condition or status of operations, management or conditions (3.4.7 of ISO 14001:2015);
    Function - purpose; resource; organizational unit - Table of common words used in ISO 9001:2015 (ISO 9000 Glossary - Guidance on selected words used in ISO the 9000 family of standards).
     
  8. Daniel Padilla T

    Daniel Padilla T Member

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    I apply Andy's approach. But I also see that Tony's argument is valid. I'd like to know what is your experience with CB's relating to this topic.

    Table of common words used in ISO 9001:2015 (ISO 9000 Glossary - Guidance on selected words used in ISO the 9000 family of standards).
    Relevant (adjective): "related to and important to that which is being considered".
     
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  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I have been ordered to require one or more goal/target/KPI for all relevant processes. Anyone who is not relevant raise their hand...

    A QC Test Lab performs tests as a support function, but risk of failure is problematic. Today I audited a lab with goals to 1) produce accurate results and 2) perform required tasks (including calibration and maintenance) on schedule.

    It is important not to overthink this subject.
     
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  10. RoxaneB

    RoxaneB Moderator Staff Member

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    What is the purpose of your organization's department and the QA team? If you are being asked to determine KPIs, the purpose of the department/team may offer some insight into possible metrics (i.e., by saying WHAT you do, you can establish measure that show HOW you are doing).

    While I agree that often times QA is involved in areas where it has little direct influence, that doesn't mean it has no influence. There is a metric/goal on my annual performance appraisal where I have no direct influence - it is dependent upon nurses (who do not report to me) completing documentation (not created by me) on time (a contractual measure not define by me). However, by developing a proactive process I was able to provide our sites with a tool to to help manage/monitor their performance on this metric and we have been trending in the right direction for the past six months.
     
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Assurance = confidence. Confidence in what? Product Quality? Since the QAD isn't responsible for product quality (the people who design and make it are), then how is "confidence" provided?
     
  12. G650ER

    G650ER Member

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    KPIs are typically much broader in scope than...what QA is doing or how it is performing. Meaningful KPIs typically are established, vetted and agreed to by all process stakeholders...my two cents
     

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