Process Measures - Linkages to Objectives and Targets

A

anil2187

#1
Process Measures- likages to Objectives and targets

Process Approach & Objectives and Targets:

"Not everything that counts can be counted, and not everything that can be counted counts." Albert Einstein

This succintly convey the message on measurements. Measures by itself doenot cause improvement unless it triggers a PDCA- LEARNING CYCLE.

ISO9001:2000 does not insist for continual improvement of all processes but there must an overall improvement of QMS as improvement of all processes may not be feasible with reference to available limited resource nor does it reflect a good business strategy at that point of time. This is achieved by having some processes maintaining status quo while other identified processes are subject to incremental and /or breakthrough improvements consistent with Quality Policy and to meet customer requirements.

So we need to identify key processes that has an impact on customer and other stake holders to improve our business. Once this is identified the process measures need to be benchmarked with either best in class or the other grade selected consciously.This gives us the gap in the process matrics to be improved to stay in business. Once this is known ,a time frame is evolved based on market needs and suitable resource requirements are planned/ fulfilled. This facilitates identification of a quantifiable improvement in the process measures that is required. Hence this becomes one of the "Quality objectives ". Consistent with this objective, the objectives(measurable) in the improvement of support processes are to be cascaded either in a direct discussion method or through a catchball process.

This requirement of ISO 9001 is not in violation of Deming's14 principles. What Deming meant was not to have a numerical target without taking into consideration of "the knowledge of the system" or interacting processes. ie Deming is opposed to numerical quotas fixed for task performers without Management assuming responsibility for process improvement. 8 Management principles embedded in ISO9000 is consistent with Deming principles. Fixing numerical targets for process output without considering process capability or taking action to improve process is against Deming principles and inconsistent with the spirit of ISO9001:2000.

Above explanation does not give any mandate to the auditor (external!) to fix an improvement target say 20%. But organization after its management's due consideration as part of their strategic business processes and consistent with resource availability ,needs of the market segment they cater to etc , shall identify this objective. This measurable objective is for the process and not for an identified task performer. It can be as explained earlier statusquo (0-10%) , incremental 10-30% or breakthrough above 30%. The target for "improvement "in a process therefore can be 0%. We are not talking about opportunistic improvements but systemic improvements caused by planned action through conscious rotation of PDCA cycle.

What is the point in dissipating our resources in getting defect levels in a process reduce by 20% when there are other important process improvements which need attention for improvement to meet competition and to ensure customer satisfaction/delight/advocacy more precariously?

The objective "to improve defect rates in receiving inspection by performing three process audits this year" therefore doesn't meet the requirement of ISO9001:2000 DUE TO:

a) Process audit in itself does not improve process quality (except for the
improvements due to attention that at times it provides)
b) It does not fix any measurable improvement target in the identified
processes
c) It does not provide any control mechanism to the process- PDCA cycle
operation in the absence of a target
d) A target is essential to plan for the resource need ( including
competence of personnel ) and to take corrective action on the strategic
business process which fixed objective earlier , to improve business in all
its meanings as and when need arise based on the learnings from the
processes operation/performance.
e) Target helps in benchmarking and associated gap analysis.

Anilkumar.s

:bigwave:
 
Elsmar Forum Sponsor
A

anil2187

#2
It may be true that other than those familiar with EFQM, MBA... Quality Awards many won't have realized that there are 8 Management principles embedded in ISO9001:2000.

But doest it matter? If it helps the user in stimulating continual improvement and enhancing customer staisfaction the --- aims of ISO9001:2K.

More than the the user Organization, it is the the external auditors who lack this understanding that results in improper implementation of the process approach emphasized in the std.

Anilkumar.s
 
A

anil2187

#3
Jim Wade said:

As for the user organization (specifically its management) I suggest they cannot possibly recognise the principles in the clauses because the principles are not there!

...I guess the sum of these behaviors is what 'management commitment' is all about?

rgds Jim
I agree with your observation. But the cause is improper taining on ISO9000:2000 GIVEN BY THE SO CALLED companies/consultant . To really implement ISO9001:2000 it is a good idea to read 9000 and 9004 which contains the 8 management principles which are also part of EFQM & MBA awards.
The lack of training has caused mis understanding in "Process approach" among people and in the formation of Objectives and targets. Many have identified process by adding the word "process " to the existing depts : Example : Production process, HR process, Marketing process, Shipping process, Purchase process.... etc without really understanding the sequence and interaction of various proceses.

Similary the measures are wrongly chosen:
Eg take "Internal Quality Auditing Process"
What can be the process measures for this process? Some companies have identified No: of NCR/Auditor Mandays as a measure of this process. It is at best a measure of process out put and not that of the process itself? Then what can be the measures?

1) No: of improvement projects triggered by the Audit process and their success rates?
2) Cycle time of the process?
3)How the result tally with external audit results?
Utimately we conclude as I said earlier:
"Not everything that counts can be counted,
and not everything that can be counted counts." Albert Einstein

Anilkumar:rolleyes:
 
M

M Greenaway

#4
anil - great posts, goes along with some of the questioning I have been throwing in about processes.

Here's another.....

You mention Internal Audit as being a process. Is it really ? Should we confine our thinking to a process being something that transforms a tangible input into an output. Does auditing do this ?

I know we can stretch our thinking to saying that the input is perhaps evidence found during audit interview, and the audit report or CA request the output. But as you have said how do we actually measure this process.

The only way is to first consider the purpose of the 'process'. We might well think the purpose of internal audit is to improve our operating methods which in turn add to the overall improvement of our business. Therefore a measure of the audit process will be wrapped up in the overall business measures, and probably unidentifiable amongst them.

But if we look at the ISO9001:2000 model we see that auditing fits in the 'Measurement, Analysis and Improvement' processes. So we might determine the effectiveness of this method of measurement by looking at the data that comes out, and comparing it to what it should be. How do we determine what the output of audit should have been ? Very Very tricky !!

Auditing sure aint an exact science, its not like calibrating a 'real' piece of measuring equipment. If anyone has any ideas I would like to know - this may be another thread !
 
E

energy

#5
Huh?

M Greenaway said:

But if we look at the ISO9001:2000 model we see that auditing fits in the 'Measurement, Analysis and Improvement' processes. So we might determine the effectiveness of this method of measurement by looking at the data that comes out, and comparing it to what it should be. How do we determine what the output of audit should have been ? Very Very tricky !!

Auditing sure aint an exact science, its not like calibrating a 'real' piece of measuring equipment. If anyone has any ideas I would like to know - this may be another thread !
M.

Just follow the standard. Don't try to interpret. Haven't you been reading? The more you interpret, the farther you get from the standard. Boy. :bonk: If I wasn't so antique, I'd seriously think about starting another carreer. Like a fishing guide or Rugby player!:bigwave: :ko: :smokin:
 
A

anil2187

#6
Auditing process

energy said:
"Just follow the standard. Don't try to interpret. "
How can we implement the spirit of a standard unless we are capable of interpreting within us and among our collegues who need it?Can we run a PDCA Learning cycle -which is corner stone of 2000 revision, without a common understanding of the standard.

We learn when we see how others interpret the standard - too!

Anilkumar
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#7
Great thread folks!!

Here is more for thought…

Inputs might be: trained auditors, audit plan, working papers, technical experts on loan; standards, procedures, instructions, forms used by the auditee, etc.

Processes: questioning, reading body language, interpretation, tracing, sampling, observing, investigating, etc.

Outputs: audit report, deviation requests, system/process/product improvements, registration, supplier approval, etc.

Anil raises a point I made in another thread that folks need to read ISO 9000 and 9004. I believe that by reading these, you will be able to interpret the guidelines better and perhaps easier.

I have always juxtaposed the ISO standard requirements to the teachings of Dr. Deming. Most of you know this all to well I suppose. I agree with Anil’s comments that the ISO standards are not out-of-line with Dr. Deming’s 14 Points. I will go so far to say that the 9000 and 9004 manuals imply many of the ideals Dr. Deming supported and is perhaps why I stress the need to read them both. However, ISO is missing “Profound Knowledge”.

I guess that the way I see it is like this: live Dr. Deming’s SoPK, you get ISO9001 registration as an ancillary benefit. Live ISO9001, you wont necessarily get (and most probably wont) Profound Knowledge.

And as my footer says: without theory, there is nothing to learn or modify.

We must recognize the need to become a "Learning Organization". If we don't, it won't be long before we are swept away..

Regards,

Kevin
 
M

M Greenaway

#8
Energy

Can you show me in ISO9001 where my points would be clearly clarified, as I do struggle. Maybe I, and others, try to read too much (or too little) into it, But I am sure you agree it isnt a crystal clear set of documents (in fact some would say not a standard at all - eh Jim).

Kevin

Your description of process inputs for auditing slightly goes against what I have been taught (although I accept that there are many different thoughts on this). I was told that something was only an input if it is actually transformed by the process. Items you describe as inputs, such as trained auditors, procedures, forms, etc are in fact 'controls'.

I know this might be seen as hair splitting, but it is a clearer picture in my mind.
 
M

M Greenaway

#9
Ah sorry Jim and Energy.

Chatting with these yanks for so long has made me lose my sense of irony.

Lovely weather eh Energy !!
 
M

M Greenaway

#10
Sorry Jim - yes trained auditors would be a 'resource' not a 'control'. Glad we have common understanding on this though :bigwave:
 
Thread starter Similar threads Forum Replies Date
D IATF 16949 Process Measurement and Efficiency Measures Requirements IATF 16949 - Automotive Quality Systems Standard 2
N YS Class in DFMEA & Process Control Measures FMEA and Control Plans 1
M ISO 22000 7.3.5.2 Description of Process Steps and Control Measures Food Safety - ISO 22000, HACCP (21 CFR 120) 1
P Measuring Process Effectiveness - Measures of Effectiveness (MOE's) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 29
P Process Measures for Every Process - TS 16949 Clause 5.1.1 IATF 16949 - Automotive Quality Systems Standard 16
Paul Simpson Measures of Medical Device Design Process Design and Development of Products and Processes 9
K "Notes" in the ISO/TS 16949 - Auditable? And what about process efficiency measures? IATF 16949 - Automotive Quality Systems Standard 1
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 1
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 5
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 4
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Error Proofing Label process Manufacturing and Related Processes 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 4
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
K Problems with process equipment ISO 13485:2016 - Medical Device Quality Management Systems 4
W Need for current design or process control FMEA and Control Plans 2
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 6
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C OEE and In-process Inspection Manufacturing and Related Processes 2
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
V Informational SMMT IATF Oversight - OEM KPI Process IATF 16949 - Automotive Quality Systems Standard 4
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10

Similar threads

Top Bottom