Product Development - When to start calculating Process Capability

v9991

Trusted Information Resource
#1
product development goes through stages of strategy - prototype - scale - validation/verification;

my question is, at what stage should we start calculating process capability index; and how to interpret them at each of the stages!.
 
Elsmar Forum Sponsor
Q

QAMTY

#2
Could You explain What Your product is? I Have seen that process capability doesnt apply completely to all products. I work in a print shop, we print, and in this phase of the process, i dont know how to apply it, if limits are not so Easy to establish them, after printing, we fold the labels,and same thing happens, could some of You share your experiences in print shops? When measuring process capability?
 

v9991

Trusted Information Resource
#3
Could You explain What Your product is? I Have seen that process capability doesnt apply completely to all products.
ours is an manufacturing process of drug device product. devices certainly come with process capability; now the question is for activity we do at our end, for assembly/manufacturing process.
its definitely relevant for us.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
product development goes through stages of strategy - prototype - scale - validation/verification;

my question is, at what stage should we start calculating process capability index; and how to interpret them at each of the stages!.
Hi,

In a product like that you actually develop to entities in parallel - (1) the device/drug and (2) the manufacturing process - whether this is done as two distinct projects or integrated. I will assume that in your case it's integrated because this is what I see more often.

Introduction of process capability monitoring is more related to the maturity of the manufacturing process than to the device design's maturity. Naturally the manufacturing process matures later, so I wouldn't expect it in the early R&D stages unless it is an explicit, high-priority requirement in your Design Input (I wouldn't commonly expect that, only where planned unit volumes are very big, unit costs are critical and production has to be very efficient).

You could start looking into process capability at the design verification or pilot production stages (again depending on your Design Input), but to me it would make the greatest sense when you scale up and do your process validation. Would be interesting to get other perspectives from (mass) production statisticians and SPC experts (I come from a stronger D&D background).

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
I ISO-9001:2015 - direction on New Product Development? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
F Development Meeting with the FDA - Approval Pathway for a Combination Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Is a confirmation trial is obligatory in development of a product? Design and Development of Products and Processes 3
M Is a confirmation trial obligatory in development of a product? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
S Product Development and Prototyping Company - Nonconforming material or not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V Examples of Design and Process FMEA for Pharmaceutical Product Development ISO 14971 - Medical Device Risk Management 7
I IQ & OQ Requirements for New Product Development Equipment Qualification and Validation (including 21 CFR Part 11) 3
T Process Validation, NPD (New Product Development), and Supplier Management Qualification and Validation (including 21 CFR Part 11) 7
K Product Realization in 'Training' - 7.3 Design And Development Exemptions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
R Role of Product Development in OSHAS 18001 Occupational Health & Safety Management Standards 6
H Product Development Lead Time with respect to APQP APQP and PPAP 2
V Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Development ISO 14971 - Medical Device Risk Management 16
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
V Any examples of Value Stream Mapping (VSM) for Product Development Processes (PDP) ? Six Sigma 3
V Measurement of Robustness of Product at Development Phase Six Sigma 2
M Measuring Personnel Performance in a Product Development Laboratory Design and Development of Products and Processes 1
V Defining Quality Assurance's Role in R&D (Product and Process Development) Design and Development of Products and Processes 11
M NPDI (New Product Development & Introduction) Examples needed Excel .xls Spreadsheet Templates and Tools 3
M ISO 9001 Certified Education Company - Defining the Product & Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P PDP (Product Development Process) and APQP Process Map APQP and PPAP 3
M SOPs for a new Cosmetic Product Development Laboratory Calibration Frequency (Interval) 1
michellemmm Software Product Development Quality Assurance (PDQA) Audit Checklists Software Quality Assurance 12
T Lessons Learned in a Product Development Project Quality Tools, Improvement and Analysis 2
C Product Development Policy and Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Generic Product Development Documents that need Analysis in a Complaint Investigation Problem Solving, Root Cause Fault and Failure Analysis 2
A What is the Responsibility of QA in the Product Development Process? Design and Development of Products and Processes 8
R Setting Departmental Objectives - Product and Process design & development IATF 16949 - Automotive Quality Systems Standard 2
5 What are your thoughts on my NPD (New Product Development) process map? Process Maps, Process Mapping and Turtle Diagrams 17
J Ford GPDS, APQP, Product & Process Development Plans, Purchasing Department Processes Customer and Company Specific Requirements 1
B New Product Development and Introduction Manual Manufacturing and Related Processes 5
T Applying Lean Tools in Product Development Lean in Manufacturing and Service Industries 2
E Product Development - Quality Manual - Subdivision of a global company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P For business performing PRODUCT DEVELOPMENT ONLY, what is best QMS for certification? Quality Manager and Management Related Issues 2
P For a PRODUCT DEVELOPMENT ONLY organization, which certification is more appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Searching for TOYOTA product development system (Toyota Production System) Customer and Company Specific Requirements 9
L Product Design and Development - How do I know if Clause 7.3 applies? Design and Development of Products and Processes 4
K Product Development Management System (PDMS) that's too complex. Manufacturing and Related Processes 4
JodiB R&D Product Development Management Misc. Quality Assurance and Business Systems Related Topics 8
E Lean Product Development Material - Basics of Lean Lean in Manufacturing and Service Industries 5
T NPD - New Product/Process Development Quality Forum Book, Video, Blog and Web Site Reviews and Recommendations 13
L Product Samples related to Design And Development Design and Development of Products and Processes 12
B Process Measure for Product Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
P New product Design & Development for automotive requirements - Documents required Design and Development of Products and Processes 4
S Product Development Program - Design, develop, approve and manufacture new products Design and Development of Products and Processes 6
S Design and development skills - No responsibility for product design and development Design and Development of Products and Processes 3
J Help! Need sample procedures for Product & Software Design and Development Design and Development of Products and Processes 4
C Design and Development Process vs. Product Design and Development of Products and Processes 10
D Risk assessment & Product development - All products - Medical device or not? ISO 13485:2016 - Medical Device Quality Management Systems 20

Similar threads

Top Bottom