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Quality assurance activity for manufacturing facility from ISO point of view

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Rajan Gupta_07, Jun 8, 2021.

  1. Rajan Gupta_07

    Rajan Gupta_07 Member

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    Hi All,
    I Would like to get inputs from all the senior members about key quality assurance activity from ISo point of view and QA perspective
    Need to support the business plan of the organization as we are coming up with new manufacturing plant.
    Please suggest what all activities can be done to meet the new plant requirement as well as the volumes/growth.

    All input appreciated
     
    Rajan Gupta_07, Jun 8, 2021
    #1
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    QA in a start-up situation is normally in guiding the development of the processes and necessary controls in the early phases, setting up the relevant procedures, such as document control and identifying records which will be produced and so on. As the project unfolds, the role becomes one of assuring that the various processes are in place and being operated, per the QMS process control requirements, leading to the required internal audits, etc. A Quality Plan may be developed as a stand alone or part of the business plan, to describe these QA activities.
     
    Andy Nichols, Jun 8, 2021
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    Jennifer Kirley and John C. Abnet like this.
  3. Rajan Gupta_07

    Rajan Gupta_07 Member

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    Hi andy,
    Thanks for your input.
    Can you please explain what does it mean when you say Quality plan...
     
    Rajan Gupta_07, Jun 8, 2021
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  4. Mahaveer Jain

    Mahaveer Jain Member

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    Quality Assurance person is the one who is responsible for any issues of quality incuding customer complaints QA can assign concerned team to close the issue inturn. QA is responsible to setup a process that yields a assured Quality. QA can fix the raw material quality required in consultation with design. QA is responsible to fix the stage wise inspection and the acceptance criteria(QA PLAN/ INSPECTION TEST PLAN/ Technical delivery Condition) QA may be responsible for acceptance of raw materials ; testing; operation procedure review/approve in consultation of HODS;QA is responsible to authorize the release of produtct; QA should be able to read and understand the standards and incorporate the same in foundry shop floor
     
    Mahaveer Jain, Jun 8, 2021
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You are welcome! A Quality Plan can be a document which calls out the very specific activities the QA folks will conduct, with specific assignments, responsibilities, procedures followed, reporting and so on. It's normal tied to a project plan (Gantt chart) and details the deliverables from each phase showing the QA roles. Let's say equipment is brought in and commissioned, and a run off of parts is conducted. QA might be involved in "buying off" the results, observing the equipment commissioning and reporting both results.
     
    Andy Nichols, Jun 8, 2021
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  6. tony s

    tony s Well-Known Member

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    A manufacturing company operates like the three branches of a government (i.e. legislative, executive and judicial). The Product/Process Engineering function is the legislative (designs what/how a product is to be manufactured). The Production function is the executive (carries out the manufacturing of the product as designed). The QA function is the judicial (evaluates the product as per the design).
     
    tony s, Jun 10, 2021
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