What is the difference between a System and a Process?

[Jim Wynne]

The organization is the system.

Marketing is one of its processes.

System comprises interacting processes.

Process is work to convert input into output.

I'm mostly ignorant in the realm of FDA requirements and I'm wondering if there's a normative distinction made somewhere in the standards/regulations between "system" and "process."

 

[John Broomfield]

John, at concept level, what you have mentioned makes total sense; once again, I totally agree with you,

But could you pl help me with certain tips in transitioning from inspection based systems into "enabling simple-agile-swiftness..." (considering that i am working in regulated industry)

Thank you.

V,

Before I develop a plan to move your organization from reacting to nonconformity to preventing nonconformity, please tell me:

• How many processes does your management system include?
• What proportion of these processes relate to production?
• What proportion of your production processes are validated (so their products need virtually no inspection)?

Meanwhile please develop your prevention thinking by study of:

Quality Without Tears by Phil Crosby

You may also want to study mistake-proofing.

Finally, does your management system already conform to your national standard for quality management systems?

Many thanks,

John

 

[John Broomfield]

I'm mostly ignorant in the realm of FDA requirements and I'm wondering if there's a normative distinction made somewhere in the standards/regulations between "system" and "process."

Jim,

Even though the system is meant to nurture the processes responsible for the products most regulators seem to remain concerned primarily about the products (and by-products).

Imagine paying lower taxes for fewer regulators to audit systems and processes (including root causes removal and mistake proofing)!

John

 

[v9991]

Jim,
to the extent i have referred the cGMP related regulations/guidelines, there is no normative/definition of process/system.

John,

How many processes does your management system include?
What proportion of these processes relate to production?

WE have to comply with requirements of cGMPs (21 CFR part 210 and 211) which mandate us to rely on control systems build around controls of "facility-people-material-manufacturing-laboratory-..."
(enclosed document ICH Q10 provides references & good understanding of equivalence with ISO systems)

What proportion of your production processes are validated (so their products need virtually no inspection)

Each product&process has to be validated; however, the regulations provide limited(or no flexibility) to avoid the inspection;

does your management system already conform to your national standard for quality management systems?

Indeed, we are compliant, but the trick(NEED) is being able to do it in most efficient manner! ( if i may put efficient...agile/enabling...)

I will start exploring the references provided by you;
Thank you for thoughts, JOhn.

 

[John Broomfield]

V,

How many processes (as requested above)?

Compliant is a legal term and may mean that you are complying with the regulations.

I am interested to know if your quality management system conforms to the requirements of ISO 9001 (or your national equivalent).

The reason I ask is that no standard has done more for prevention than ISO 9001.

It even includes clauses for obtaining the required degree of agility: 4.1, 5.4.2 and 7.1.

Many thanks for answering these questions,

John

 

[v9991]

How many processes (as requested above)?

I am herewith listing out the processes...
Product Development - supplier qualification and procurement - process validation - warehouse/material management - manufacturing&facility controls - quality control - quality assurance ;

Each of the above area are in-turn supported by individual procedures. (viz., QA includes, change control, incidents, complaints, ...)

Business development, Marketing, Distribution and others are not directly under purview of QMS but they are all compliant with relevant regulations.

I think,Following document enlists the equivalence of ISO & GMPs.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf

 

[John Broomfield]

I am herewith listing out the processes...
Product Development - supplier qualification and procurement - process validation - warehouse/material management - manufacturing&facility controls - quality control - quality assurance ;

Each of the above area are in-turn supported by individual procedures. (viz., QA includes, change control, incidents, complaints, ...)

Business development, Marketing, Distribution and others are not directly under purview of QMS but they are all compliant with relevant regulations.

I think,Following document enlists the equivalence of ISO & GMPs.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf

V,

Thinking that your management system conforms to ISO 9001 because it complies with cGMP may be part of the problem. CAPA for example is completely at odds with Preventive Action in clause 8.5.3 of ISO 9001.

For your quality system to be fast and agile you need to develop, use and improve your company's process-based management system so conforms to ISO 9001 including your speed and agility criteria included in 4.1c and 4.1d.

Then, by your company's use, monitoring and optimization of its system. it will determine and fulfill requirements including compliance with the regulations.

Your plan (to move from a quality system built around the regulations to a management system that is designed to be fast and agile) must protect the integrity of the system as it is changed.

Tips:

Agree upon the speed and agility objectives with top management as part of the other company objectives.

You could then used these speed and agility criteria to drive incremental improvements of your system and its processes over the next decade.

Or, you could go for a faster change by making sure your management system is process-based and conforms to ISO 9001:

Work with top management to analyze and document what your company does with its customers, suppliers and regulators to convert the needs of customers into cash in the bank. This is the value stream or core process.

Determine the key processes (including the processes necessary to sustain the core process) and work with top management to assign subject matter experts as process owners (one per process).

Brief/train the process owners on the planned changes to fulfill the approved objectives including the speed and agility criteria.

With each process owner analyze and document process as it is (search the Cove for the SIPOC approach).

Use and improve your updated process-based management system to fulfill the speed and agility criteria while preventing nonconformity and fulfilling the other requirements including compliance with the regs.

Please note that I would recommend using a process-based management system to secure the changes in your organization (system) that you want.

Good luck,

John

BTW, I do not see quality control and quality assurance as processes.

These days QC is part of process control (ASQC was several years late in dropping the C).

For more than a decade, QA is a result of working systematically to prevent nonconformity thereby delivering confidence that requirements will be fulfilled.

In other words QA is a product delivered by the system not a fancy name for inspection.

 

[v9991]

John, Thank you for Invaluable thoughts. They have got me started with direction.

There is another quick opinion I would seek...
ISO 9000s have come into picture with the advent of ICH Q10.
Since we are into more of drug product manufacturing(some of them falling into combination categories, viz., inhalers etc.,)
what are your thoughts on aligning with ISO 13485 (instead of ISO 9000s)
I have this question, especially because, I have seen much work done on aligning both the systems. (part 820 vs 13485)

 

[John Broomfield]

John, Thank you for Invaluable thoughts. They have got me started with direction.

There is another quick opinion I would seek...
ISO 9000s have come into picture with the advent of ICH Q10.
Since we are into more of drug product manufacturing(some of them falling into combination categories, viz., inhalers etc.,)
what are your thoughts on aligning with ISO 13485 (instead of ISO 9000s)
I have this question, especially because, I have seen much work done on aligning both the systems. (part 820 vs 13485)

V,

ISO 13485 includes all of the requirements of ISO 9001 except continual improvement.

So, ISO 9001 should be the basic standard used for your process-based management system.

You can then make the necessary changes (especially w.r.t. scope and risk management processes and control) to conform also to ISO 13485.

John

 

[Solinas]

My understanding is that, systems usually formalize/document various interactions of processes.

Usually, we hear the Quality system hinder the swiftness/agility of the processes; is it true?

Which one of them is real culprits/bottle-necks? process? or systems?

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.