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so....I have an issue

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by nmcadam78, Feb 8, 2018.

  1. nmcadam78

    nmcadam78 New Member

    Nov 22, 2016
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    Wirral, Merseyside
    So, I've recently been tasked with taking over a recently acquired company's QMS and transition it to 2015 standards. They have done no work towards transition as the acquisition took 18 months and they were aware we had QA resource (they previously used consultants.

    Today I went in to the company to perform a gap analysis and formulate a plan. When I asked the question 'what are your objectives, both strategically and QA related?' the response came back from the FD that 'we set a budget each year and see how much money we can make with that budget'.

    I guess that's a plan of sorts, but there were no formal targets put into place.

    I tried to explain that to fall in line with the new standard, objectives must be set to achieve your intended strategic direction and that the QMS must enable and support that strategic direction. The result was blank stares across the table.

    The difficulty I have here is that I have 5 directors that share equal responsibility, with nobody having more power/influence than the other.

    Has anybody encountered this and does anybody have any advice on educating them?
  2. PDCA Unicorn

    PDCA Unicorn New Member

    Feb 2, 2018
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    I typed the narrative below as a guide for our transition. Feel free to incorporate it into one of your meetings to help persuade them. A power point to deliver information would be an excellent tool. I also attached the two charts that I made to assist in setting the goals. It seemed to help quite a bit.
    One thing to remember is: You are already measuring things, you can use what you are already measuring as objectives. They just have to be recorded, monitored, and planned for. "Quality Objectives" do not have to be relegated to the "Quality Department" - The QMS encompasses the entire organization.

    It sounds like you have a bit of hand holding to do, and that's okay. You can get them on board.
    What are objectives?
    What do they mean for us?

    Objectives are measurable goals that relate to our commitments to quality. Quality does not just mean the "Quality Department" - it is a commitment throughout the entire organization. Objectives can be anything that matters to the success of ***** - Some of which we have laid out in our Quality Statement. What has leadership at ******* decided matters for success:
    1. <Statements made in quality policy>
    2. <Statements made in quality policy>
    3. <Statements made in quality policy>
    4. <Statements made in quality policy>

    Our Objectives will help us achieve the success we desire by planning to achieve what we laid out in our quality statement and satisfying the following requirements:
    1. Objectives must be established throughout the organization. All Relevant functions and levels - Anyone who is relevant in the organization will have some objective that applys to them. For example: Internal reject monitoring applies to the operators.
    2. Supporting the quality policy (As laid out above). You need to plan and drive change around this statement. Merely having a statement will accomplish nothing, use our objectives to push this statement.
    3. Objectives must be measurable. Vague objectives cannot be measured or met. Example: Increase profits. This is a good objective, but - how much do you want to increase profits, and how are we going to achieve this?
    4. Consider requirements that are applicable to the success of your organization when selecting objectives. What special requirements to we have that drive success?
    5. Be relevant to the conformity of products and to customer satisfaction. We circle back to that on time delivery commitment in our mission statement.
    6. Monitoring. We need to continue to check up on the the progress of meeting these goals. How often are we going to monitor these goals? Who is responsible for gathering the data? How is this data displayed? How is this data analyzed? Are plans for achieving the goals also measured?
    7. Communication. Objectives and progress need to be communicated - without that communication, employees won't know what you value in the success of the company. Use the company meetings to remind the employees of the objectives, why they are important, and what they can do to help achieve the objectives.
    8. Be revised as often as needed. As the business changes, so will our objectives. We need to ensure objectives are adaptable.

    The final requirement for objectives is planning. We must plan how we are to achive the objectives we set. To do this we need to satisfy the following:
    1. What will be done.
    2. What resources are required.
    3. Who is responsible? (Who will measure and collect data?)
    4. When will it be completed? (How often will it be measured?)
    5. How will the results be evaluated? (How do we decide if we have been effective? When are these results reviewed?)

    Objective Chart.jpg

    Planning Chart.jpg
    QC Dave likes this.
  3. normzone

    normzone Well-Known Member

    Aug 3, 2015
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    Welcome to the forum, [nmcadam78].

    The above looks like a good starting point - I may file the serial numbers off it, paint as required and repurpose it for my own use :)

    I am facing a similar situation at a much smaller organization, and if there was a market for Quality Assurance reality shows I'd have a script to pitch to the producers. Unfortunately, it's such a limited audience that the advertisers aren't interested - probably not enough opportunities for car chases and gratuitous skin.
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Jul 31, 2015
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    Does this company have a business plan? If so, a lot of what's in it can be applied and there will then be some blanks to fill.

    Sensible people know we can't make money out of just wishful thinking, but often people think objectives are complicated, abstract things. That is not only not practical, complication can put up walls that enable people to shy away from actively participating. When I get blank looks (as I so often do) I ask "What does failure look like?" because people almost always know that. How we recognize failure (making money is an effect, not an objective, so we can't use profits as an indicator) can also be how we recognize success.

    I do appreciate the list you've made, it is very straightforward and I like the focus you placed on the customer.
  5. Golfman25

    Golfman25 Well-Known Member

    Nov 6, 2015
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    A couple of thoughts. First, what is the plan to incorporate the acquired business into the purchaser? If they are going to be integrated with new management philosophy, maybe it is premature to update their QMS.

    Second, I would get rid of the quality or business jargon. When you ask a finalized statement -- "what are your objectives" - average Joes will say to survive the day and make it home. "Objectives" are too theoretical for many people. The better question imo is "what are we trying to do?" "how are we doing it?" or some variations. Thru the conversation you can formulate their objectives that they didn't even know they had. Bottom line, don't overcomplicate it. Simplify it and walk them thru it.
  6. John C. Abnet

    John C. Abnet Well-Known Member

    May 23, 2017
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    Upper Midwest- USA
    Good day @nmcadam78
    You are not the first to encounter this. As you are likely aware, the newest revision (2015) of the standard places significant more emphasis on process owners, and "who-what-when....

    6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
    a) what will be done;
    b) what resources will be required;
    c) who will be responsible;
    d) when it will be completed;
    e) how the results will be evaluated.

    As you can see, the "5W-1H" approach is now highly supported by the standard (when I conduct internal audit training I emphasize the benefits of this approach prior to looking for any specific clause or "shall" requirements.) I would suggest that you utilize this portion of the standard to support and emphasize the need ("...shall determine...") to expound beyond simple claims (i.e. "we will make profit".)

    Hope this helps.