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What does a Quality System look like?


RR1

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Today I was asked by a colleague to describe what I thought a Quality System was/ looked like. I can draw what I think it should be, but find it difficult to explain in simple words.

How would you describe this - specifically to your staff but also to ordinary folk?

Thanks

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Quality Systems provide the framework in which work is performed, in our case immunohematology testing but it really can be applied to any work. The framework supports and controls the work by providing structure, organization, expectations, consistency, assessment, evaluation, and continuous improvement to the process. The outcome from the use of the framework is high quality results from the work performed.

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Quality Systems are big, hairy and ravenous. They eat paper, printer cartridges and lots of time. They are hard to see unless you have "audit glasses" on.

Thanks Tim, I'll try your description on senior management.......may I should add some 'hairy bits' and teeth to my diagram too???

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Quality Systems provide the framework in which work is performed, in our case immunohematology testing but it really can be applied to any work. The framework supports and controls the work by providing structure, organization, expectations, consistency, assessment, evaluation, and continuous improvement to the process. The outcome from the use of the framework is high quality results from the work performed.

Thanks Jeanne, so most of us have really always had some sort of Q.S in place- we may have just seriously neglected them so they were covered in moss and ivy, and possibly even bio-degraded to an extent.

I suppose a bit of TLC (or a whole shed load in some instances!!)should help restore these. May be we need to think more kindly about our Q.S systems, I certainly appreciate the one we are developing, even though it is difficult at times to reach initial standards.

I don't suppose this has helped Claudia any further...just my ramblings to help me through the following weeks with 'quality stuff '.

Edited by RR1
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Rashmi ~

I think you have it exactly. :) I know when I started grappling with Quality Systems when the FDA first started focusing in on quality, I started out thinking it was some big complex process. I went to a bunch of programs and people used boxes and arrows and much explanation – seemed rather magical and, frankly, I was confused. Then suddenly the light bulb went on. It seemed as soon as I started thinking about it as the structure or framework for work being done, I could just work on what I had. I quickly moved on to trim and prune and add a fair amount of fertilizer to what was already in place. Then, with a strong framework created, it was easy to pass all the quality audits and inspections that came my way.

Jeanne

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Thanks Jeanne- love the term Quality Garden, definitely brings in a new dimension. I will try to think of this in future as a live, organic process, ever maturing, demanding at times but should become independent at some stage and only require a little tweak to keep it going.

Getting hold of the fertilizer can be a problem though!

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What I used to create our Blood Bank Quality System or Quality Manual is a publication from the AABB Press. It is titled "Quality Manual Preparation Workbook for Blood Banking", 2nd Edition. It comes with a workbook and a CD with templates already prepared for you, all you'll have to do is edit them to fit your institution. It was straight forward and very easy to do. ISBN #: 1-56395-204-1

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  • 4 weeks later...
Just had to put in (from Demotivational Coffee Mugs:

Quality: The race for quality has no finish line, so technically, it's more like a death march.

Thanks for the laugh!

But looking at this in a (more positive ?) different way: "Quality is a Journey not a destination."

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  • 5 months later...

true compliance is not just about a tick in a box, it's also about identifying areas for improvement, managing resource more effectively or getting user buy in ........

A quality system should give you a comprehensive system to manage the entire range of compliance and regulatory activities throughout your organisation.

Hopefully the system will encourage ownership of your compliance management system, reduce the bureaucracy usually associated with compliance and, crucially, deliver improvement in bottom line performance and the opportunity to advance through your compliance efforts.

All of this can be achieved in 7 simple steps:- define and document/ publish and distribute / train and develop staff / verify compliance / capture issues / analyse audits and issues / improve and grow

These 7 key steps can make a lasting difference to your organisation and transform the necessary compliance and regulatory activities from a costly overhead into a business benefit with proven competitive and commercial advantage

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