QMS Overload

DesantisJ said:

I am a new Quality Manager for a company. This is my first job "quality" job, my other experience is as a manufacturing engineer. I was a trained AS9100 internal auditor for my past job and was often tasked with reviewing and revising many process documents, so I am familiar with reviewing QMSs.
My situation is this: My new company is not ISO certified nor do they have what I would define as a Quality Management System. The owner has expressed a desire to be certified but has also shown it not to be a top priority since our customers have not requested it of us. I want to help this company to succeed, but this task is currently too daunting for me to decide where to step first. I've found un-released procedures that attempted to align with ISO9001:2008, but they were never implemented.
My boss is hoping to see results in the form of reduction of non-conformances. My brain is telling me to start with a receiving inspection procedure, but there are a lot of holes in the process before we've ever received these parts, both in-house and out-sourced machined parts.
My question is, where do I even start with this project? I know the best way to eat an elephant is 1 bite at a time, but would you start at the snout or the tail?

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mindytanner said:

You start at his feet, of course! Then he can't get away!!
The best way to start is keep a notebook & pen with you everywhere you go. Every time someone preforms a task, ask them how they do it, and document it. Example, contact a Supplier to inform them of defective material. Then you document it in some way. I prefer flow charts. Next, compare what is being done to what the standard requires. This will help you build a gap audit while also learning the processes at your new company. I started doing that at my job. The plant was slated for closure. Senior leadership changed and the facility did not close. However, they had let their certificate expire. I show up and there is no evidence of a QMS so, rather than totally recreate the wheel, this is what I am doing. Some of these team members have been here doing same thing for over 25 years. If something is required but not being done, I only have to ask them to change that one thing. That is a much easier sell than to totally write a QMS just from the standard.

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Big Jim said:

Be careful with this approach or you may end up with a very awkward over documented QMS that becomes a monster to manage. A good deal of my consulting work is helping companies pare down their bloated QMS.

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Big Jim said:

Be careful with this approach or you may end up with a very awkward over documented QMS that becomes a monster to manage. A good deal of my consulting work is helping companies pare down their bloated QMS.

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mindytanner said:

In my experience, it been most helpful to make sure that you are documenting what is needed for the organization to function. That is really what the intent of the standard, then other big organizations want to add in their expectations, and so on, and so on.

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DesantisJ said:

Hello all,
I am a new Quality Manager for a company. This is my first job "quality" job, my other experience is as a manufacturing engineer. I was a trained AS9100 internal auditor for my past job and was often tasked with reviewing and revising many process documents, so I am familiar with reviewing QMSs.
My situation is this: My new company is not ISO certified nor do they have what I would define as a Quality Management System. The owner has expressed a desire to be certified but has also shown it not to be a top priority since our customers have not requested it of us. I want to help this company to succeed, but this task is currently too daunting for me to decide where to step first. I've found un-released procedures that attempted to align with ISO9001:2008, but they were never implemented.
My boss is hoping to see results in the form of reduction of non-conformances. My brain is telling me to start with a receiving inspection procedure, but there are a lot of holes in the process before we've ever received these parts, both in-house and out-sourced machined parts.
My question is, where do I even start with this project? I know the best way to eat an elephant is 1 bite at a time, but would you start at the snout or the tail?

Click to expand...

1. Assessment - you can take advantage of being new to the company and see everything with a fresh set of eyes:
   1. You can identify where things are inefficient and note those down as a possible area to address.
   2. You can check if there are higher occurrences of issues in any one particular area in the company like - service issues, complaints, part rejection, supplier issues, etc. You can keep a note of this.
   3. You can check open CAPAs (if they don’t have a CAPA system, then anything that is close to that) and see if there is any systemic problem that should be tackled first.
   4. Previous audit reports of their company (if it exists) from their customers or external parties, can also come handy.
   5. You can identify what is the source of all the non conformances, see trends, conduct or review root cause analysis, and try to pin down the recurring underlying cause for the NCs. Even though there could be multiple things leading to NCs, there can be one which is one of the biggest reasons.
   6. Any other analysis (at the site) and previous record review will also be helpful.
2. Planning and prioritization - Once you have finished the assessment, put together the list of identified issues and a timeline to address those. You can prioritize based on business and customer risk - take a risk based approach here. Of course this should be presented to the stakeholders (you boss, management, etc.) as you see fit and they should buy into this.