What is the difference between a System and a Process?

[Kevin Mader]

The first thing that came to mind was a posting that I saw on the internet long, long ago that’s made a lasting impression on me. The posting was an image of a letter received by a gentleman, who worked for New York City. He had written a letter to Dr. Deming thanking him for inspiring him to make New York City a safer place. Dr. Deming wrote back to this gentlemen and said something like this (I once had in committed to memory, but it fades) –

Dear So-in-so,

Your letter from 10 November 1990 has been sitting on my desk for a very long time. I applaud your efforts to make New York a safer city. However, the problem goes well beyond the city limits. Good luck in your endeavor.

W. Edwards Deming

The point here is that the System is a very broad thing and is more than a collection of interrelated processes. When I think about Systems, I think about groups (customers, manufacturers, communities, suppliers, government agencies, etc.) and of the 5Ms and an E as constituent parts. Others, such as Fiegenbaum, broke it down even further. True enough, there are many definitions for what a system is but the constituent parts aren’t that much different, if at all (scale may change for a QMS, for example), and something to keep in mind. I thought it was worth mentioning.

Regards,

Kevin

 

[Kevin Mader]

A System is a set of Processes.

Focusing first on processes leads to local optimization, which is usually not as good as optimizing the system, and then setting the processes to support your overall system goals.

This is a correct statement in my opinion. There was a thread started here more than 8 years ago that discussed localized optima as supported by a processed based ideology like ISO 9000 (13485). Folks need to understand that standards like ISO or the CFR can help organizations to establish systems that fullfil generally accepted quality requirements, but it cannot in itself be everything to deliver quality and business excellence. Much more is needed.

Regards,

Kevin

 

[PE-2011]

Re: what is system and process

Dear Ka Pilo, really excellent example

 

[The Specialist]

1. A system in the context of management/quality:

A system is a detailed method, made up of interacting procedures, processes and requirements, required to satisfy the whole; the ‘system’.

A process is a singular or, culmination of singular (integrated) practices/methods that determines the outcome of an independent effort and the overall system.

2. In a ‘physical’ context, e.g. a manufacturing process:

A system is the sum total of independent processes or manufacturing steps that make up an integrated/group of processes, achieving an expected end result, where the removal of a process or manufacturing step would prevent the ‘system’ from functioning correctly. e.g:

A ‘clean-in-place (CIP) system’ is made up of distinct ‘processes’:

· WFI (water) is circulated (pumped) in a distribution loop
· A header tank provides a buffer from the loop, which gives capacity
· Valve sequences are controlled by automation (separate system)
· Monitoring devices monitor the water quality
· Detergent injection pumps control detergent quantities
· ETC… (I think I have made my point!)

Each part of the system is process, as teach step has its own set of criteria/control functions…etc.

3. Now;

You can conclude that the whole ‘set of processes’, including management and quality processes (as described in point 1) and the physical processes (point 2) is a ‘system’ in itself, then a system becomes broader still!!


Am I just rambling at this point?!!!

 

[v9991]

Folks need to understand that standards like ISO or the CFR can help organizations to establish systems that fullfil generally accepted quality requirements, but it cannot in itself be everything to deliver quality and business excellence. Much more is needed.

baring few exceptions, i get a general perception that "Quality" in regulated-environment "starts and ends with ""Compliance!!!"".(Compliance :- set of processes/procedures implemented inline with the regulations/CFR!!! ) It is quite a task for conditioned!!!-pharma-guy to change the track of compliance --> start talking Quality!!!

It is only in late 2000 that QS based GMPs / ICH Q10 have been much commonly discussed in industry circles... and off-late, FDA started emphasis on the RCA/CAPA.

btw, Right now, we have taken the Incidents (non-conformance) as target process to improve the efficiency/effectiveness(CAPA)

in the above context, for a typical environment compliant with CFRs, what would be starting point/targets for making progress from compliance-consciousness --> quality -consciousness!?!

 

[sagai]

It is funny, how you guys let to release the kraken
Check 9000 terminology section, that is all. (3.2.1&3.4.1)
br.
Sz.

 

[Kevin Mader]

baring few exceptions, i get a general perception that "Quality" in regulated-environment "starts and ends with ""Compliance!!!"".(Compliance :- set of processes/procedures implemented inline with the regulations/CFR!!! ) It is quite a task for conditioned!!!-pharma-guy to change the track of compliance --> start talking Quality!!!

It is only in late 2000 that QS based GMPs / ICH Q10 have been much commonly discussed in industry circles... and off-late, FDA started emphasis on the RCA/CAPA.

btw, Right now, we have taken the Incidents (non-conformance) as target process to improve the efficiency/effectiveness(CAPA)

in the above context, for a typical environment compliant with CFRs, what would be starting point/targets for making progress from compliance-consciousness --> quality -consciousness!?!

V9991,

I think that you might be right: in regulated businesses, 'quality' and 'compliance' seem to be discrete It's my impression that FDA has contributed to this line of thinking (businesses protecting themselves ahead of other objectives, including 'quality'), although from personal experience, I know investigators can be very interested in the quality side of things. As this becomes more common, industry (pharma or medical device) will respond. But who will be the pioneers?

I believe that an organization's leadership must establish the linkage between 'quality' and 'compliance'. Conformance to specifications will not necessarily result in a positive user/patient experience. While perhaps being compliant to intended uses, the experience may fall short of needs and expectations. How is this data captured? How often? And where is it shared? Earlier in the thread, John points out an important distinction between ISO 9000 and ISO 13485: continual improvement. One could associate that this difference is a contributing factor to the organizational culture of 'compliance' instead of 'quality'. Business spend a great deal of money and effort on being compliant, so the well dries up for continual improvement efforts a lot of the time. But there are things that can be done to re-align the workforce and promote both initiatives. The key is identifying opportunities and gaining the engagement of others.

So, it isn't so much a transition from one to the other. I think its more about leadership communicating that the two are not discrete and finding ways to champion efforts that combine the two. This is more delicate in an environment where validated states of design and production exist, but it's far from impossible. For example, an educated workforce sensitive to the frozen states of design and production will know that they can't deviate from SOP, but that shouldn't stop them from offering suggestions on improvement to product or processes. What does your organization do to promote their engagement?

Regards,

Kevin

 

[JaneB]

Kevin,
Hope this doesn't sound picky, but think you may mean 'discrete' (as in, separate) rather than the often-confused homonym 'discreet'.
Meant to say: excellent post!

 

[Kevin Mader]

Jane - yes, you are right. Fingers typing faster than the eye! Watch your wallet!! And thanks!!

Kevin

 

[v9991]

That was an excellent post Kevin, You almost read the situation in here(pharma domain!)

...But who will be the pioneers?....

we know for sure that Big-MNC are definitely into it; But, theres little to hear about it elsewhere; almost nothing to read about it in open-domain. (Apart from this excellent forum, where people like you, John are actually putting forward directions/thoughts...otherwise it is restricted to some ppts, ...nothing of sorts of hands on implemtation package as is available with ISOs)

and as mentioned earlier, regulators are pioneering the efforts by laying emphasis on continual improvement(RCA/CAPA),

...The key is identifying opportunities and gaining the engagement of others.

Again initiatives of Quality systems based GMPs, Quality by Design etc., are right notes; but then again, its regulator's initiatives and they are guidances(not rules)!!!

Once again, the problems(issues/delays/cost) are triggers; and its interesting that here regulatory rules/policies come against the dynamic changes. (of course Quality by Design hastriggered the change in approach...but its yet to be taken to run-way...(its still in pilot stage!!!).!!!

Looks like there is a very big learning curve ahead of industry & regulators in attaining next level.

...what does your organization do to promote their engagement?...

most of the discussions start & end with compliance!!!
may be there is separate/different trick to start the engagement....First have a policy and plan in place; (amalgamating the ISO QS and cGMPs)
Yes, it may also be limited by my(ppl like me) exposure to QS

As indiciated earlier, I am glad that we got started on right foot in this direction by focussing on RCA& CAPA as areas of immediate focus.