Design and Development Measureables - ISO9001:2000 Clause 7.3

#1
Has anyone successfully established measureables for the clause 7.3 section of ISO9001-2000 Design and development? I am currently working with an automation and specialized machine builder for automotive that does complete design , mfg and installation and service of equipment. We are trying to develop usable measureables for this area and are having a difiicult time developing. Thank you in advance.
 
Elsmar Forum Sponsor
#2
Re: ISO9001-2000 7.3 Design and development measureables

That's correct - Engineering don't like to be measured, if you do that, then you know it's out of spec..............:lmao:

Seriously, Engineering can be measured usefully by three key results:-

Meeting development milestones - set by the customer or by internal requirements. Since development time is expensive, no-one should be late/over budget.

Depending on your development methodology, reducing the 'iteration's of design, through each phase (concept model, prototype model, engineering/pre-production model) is a good thing. This gives opportunity to decrease last minute changes, the nearer to market launch you get

Post release/design freeze changes (except for customer required ones which you could get paid for). These are most useful, since no-one wants to touch a design after release and it's costly ($1000-2000 a change to process).There are other costs asscoiated, in my experience, like the turn over of new design engineers because their first assigments are to fix someone else's design........

Any more?

Andy
 
D

Duke Okes

#3
Re: ISO9001-2000 7.3 Design and development measureables

David M McInerney said:
Has anyone successfully established measureables for the clause 7.3 section of ISO9001-2000 Design and development? I am currently working with an automation and specialized machine builder for automotive that does complete design , mfg and installation and service of equipment. We are trying to develop usable measureables for this area and are having a difiicult time developing. Thank you in advance.
- ratio of actual achieved process capability vs. customer-required capability
- number of design changes required after installation
- equipment uptime/reliability
- maintainability
- space utilization
- number of adaptations done by customer in order to make it work (e.g., things that operators do to machine as work-arounds)
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#4
David M McInerney said:
I am currently working with an automation and specialized machine builder for automotive that does complete design , mfg and installation and service of equipment.
:topic: Congratulations, Dave!! Hope you enjoy your new job.
 

Helmut Jilling

Auditor / Consultant
#5
Re: ISO9001-2000 7.3 Design and development measureables

AndyN said:
That's correct - Engineering don't like to be measured, if you do that, then you know it's out of spec..............:lmao:

Seriously, Engineering can be measured usefully by three key results:-

Meeting development milestones - set by the customer or by internal requirements. Since development time is expensive, no-one should be late/over budget.

Depending on your development methodology, reducing the 'iteration's of design, through each phase (concept model, prototype model, engineering/pre-production model) is a good thing. This gives opportunity to decrease last minute changes, the nearer to market launch you get

Post release/design freeze changes (except for customer required ones which you could get paid for). These are most useful, since no-one wants to touch a design after release and it's costly ($1000-2000 a change to process).There are other costs asscoiated, in my experience, like the turn over of new design engineers because their first assigments are to fix someone else's design........

Any more?

Andy
Very well stated. I like the examples given in the other posts, but I think these address the most important criteria for ths process.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#6
Re: ISO9001-2000 7.3 Design and development measureables

AndyN said:
That's correct - Engineering don't like to be measured, if you do that, then you know it's out of spec..............:lmao:

Seriously, Engineering can be measured usefully by three key results:-

Meeting development milestones - set by the customer or by internal requirements. Since development time is expensive, no-one should be late/over budget.

Depending on your development methodology, reducing the 'iteration's of design, through each phase (concept model, prototype model, engineering/pre-production model) is a good thing. This gives opportunity to decrease last minute changes, the nearer to market launch you get

Post release/design freeze changes (except for customer required ones which you could get paid for). These are most useful, since no-one wants to touch a design after release and it's costly ($1000-2000 a change to process).There are other costs asscoiated, in my experience, like the turn over of new design engineers because their first assigments are to fix someone else's design........

Any more?

Andy
I would say four as
"Meeting development milestones - set by the customer or by internal requirements. Since development time is expensive, no-one should be late/over budget."
is really two.
Time and money are both measurables which can be in conflict with one another.
Both should be measured independently IMO
 
Thread starter Similar threads Forum Replies Date
R Role of QA during Design and Development of Products and Processes Design and Development of Products and Processes 3
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
L Design & Development of a SERVICE Service Industry Specific Topics 13
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
M Design Development MDR Design and Development of Products and Processes 0
O How can I justify excluding the R&D group and the design and development clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 6
A Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S ISO 9001 Clause 8.3 - Design & Development for training course center ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
AlienraverX Design and Development Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
K Design and Development Exclusion Quality Management System (QMS) Manuals 1
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
S Waterfall model or v-model design and development ISO 13485:2016 - Medical Device Quality Management Systems 2
JoshuaFroud Design and Development of Software under 13485:2016 or 62304? ISO 13485:2016 - Medical Device Quality Management Systems 6
M IATF Clause 8.3 - Design and Development IATF 16949 - Automotive Quality Systems Standard 5
K Design and Development Exemption/NA confusion Design and Development of Products and Processes 6
C AS9100 8.3.5.e Design and Development Outputs - Key Characteristics / Critical Items AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
S Purchasing for Design and Development Organization ISO 13485:2016 - Medical Device Quality Management Systems 3
qualprod Development separated from design? ISO 9001 cl. 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Design and development of user centric audit report visualisation tool Design and Development of Products and Processes 5
D IATF 16949 Design and Development Planning IATF 16949 - Automotive Quality Systems Standard 1
M IATF 16949 Cl. 8.3 - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 1
P Design and Development Clause ISO 9001:2015 Exclusion for Medical Services Design and Development of Products and Processes 3
A ISO 13485:2016 Certification for Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 0
H IATF 16949 Cl. 8.3 - Design and Development Exclusion Question IATF 16949 - Automotive Quality Systems Standard 4
R Development of Design FMEA - Functional Requirements FMEA and Control Plans 1
G ISO 9001:2015 8.3 Design and Development (in Civil Engineering) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M AS9100D excluding Design and Development - Small Job Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
Moumen H API Spec Q2 Design and Development Requirements for Service Providers Oil and Gas Industry Standards and Regulations 11
T Design Changes - Updating the Design and Development File EU Medical Device Regulations 5
Y ISO 9001 Cl. 8.3 - Design and Development of Products and Services not applicable ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J ISO 9001:2015 8.3.2 f) - Interfaces between Persons in Design & Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Company) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
I Design & Development, Research and Innovation in the Medical Device framework ISO 13485:2016 - Medical Device Quality Management Systems 3
M Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Design and Development Procedure example and Template wanted - AS9100 Rev D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D Recommended Training for Design Engineers in IATF 16949 Cl.8.3 - Design & Development Design and Development of Products and Processes 0
B IATF 16949 Section Clause 8.3.4.1 - Monitoring - Design and Development Input(s) IATF 16949 - Automotive Quality Systems Standard 3

Similar threads

Top Bottom