What are the minimum required MSA studies for a TS 16949 PPAP?

C

celso klitzke

#1
We had a great discussion and no conclusion at all.

To satisfy ISO TS 16949 registars, what are the MSA minimal required studies to be conducted (or avaliated to know if they are significant in a particular aplication)?

These studies must be conducted for all the caracteristics of the part that can be critical, affect safety, or invalidate the expected part performance?

And the calibration of the instruments, must meet which measure uncertainity criteria?

Any help will be well received.

Thanks in advance,

Celso :bonk:
 
Elsmar Forum Sponsor
D

D RAVINDRAN

#4
Msa....and Ts2

The requirement for MSA is given as 7.6.1 MEASUREMENT SYSTEM ANALYSIS in TS 16949.

The MSA requirement shall applied to the references available in Control plan.We can carryout MSA for family of
Checking devices.
 
Thread starter Similar threads Forum Replies Date
S What is the minimum pressure differential required for ISO Class 8 Clean Room? ISO 13485:2016 - Medical Device Quality Management Systems 3
B What is the minimum sample required for Performance Evaluation for IVD ? EU Medical Device Regulations 3
S What is the minimum samples required for Customer Survey? Quality Manager and Management Related Issues 3
S Minimum documents required by AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q Minimum content required in a Quality Manual as per ISO 9001:2008 Quality Management System (QMS) Manuals 6
S Monitoring is 1/shift. Is this the minimum required? CQI-11 Expert needed. IATF 16949 - Automotive Quality Systems Standard 3
T Minimum training and experience required for an Internal Auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M What is the Minimum Documentation Required for Medical Device Industry? ISO 13485:2016 - Medical Device Quality Management Systems 3
A The Minimum Number of Internal Auditors Required in an Organization Internal Auditing 37
Q Minimum Quality records required by ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
K What is the Minimum number of internal auditors required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R Quality Control Engineer: What are the minimum skills/qualifications required? Career and Occupation Discussions 4
N What are the minimum quality records required by QS-9000? Records and Data - Quality, Legal and Other Evidence 1
D Subcontractor Development - What is Minimum Required? Clause 4.6.2.1 QS-9000 - American Automotive Manufacturers Standard 13
P ISO 9001:2000 - Required Procedures or minimum required number? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 45
D LiPo battery minimum requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Search function minimum length Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Capability study with a minimum spec Statistical Analysis Tools, Techniques and SPC 8
L Significant Production Run - How 300 was determined to be the minimum quantity APQP and PPAP 2
Marco Bernardi MMC & LMC modifiers and CMM measuring techniques like diameter least squares and circularity or minimum/ maximum diameter Calibration and Metrology Software and Hardware 5
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Minimum Supplier Certifications for Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 4
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
M Applicability of IEC 60950-1 Table K2 - Minimum clearances between circuits Various Other Specifications, Standards, and related Requirements 0
M Characterization Testing - NO acceptance criteria, no minimum performance requirement Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
K Is minimum repair or replace guarantee period for medical devices in EU the same as consumer guarantee law of 2 years? EU Medical Device Regulations 5
S Designing the experiment with minimum run Statistical Analysis Tools, Techniques and SPC 0
S Designing the experiment with minimum run Statistical Analysis Tools, Techniques and SPC 0
JoshuaFroud Change Control - Minimum Requirements and Unhappy Staff ISO 13485:2016 - Medical Device Quality Management Systems 16
J IATF Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers IATF 16949 - Automotive Quality Systems Standard 12
N ETO Sterilisation Validation - EO Residual Minimum Sample Requirement ISO 13485:2016 - Medical Device Quality Management Systems 2
F Regulatory Compliant Quality Management System - Bare Minimum EU Medical Device Regulations 2
somashekar ISO 13485 plus ISO 9001:2015 will now attract a minimum 2 day upgrade audit ISO 13485:2016 - Medical Device Quality Management Systems 9
J Minimum staff per 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D What is the minimum Sample Size for Weibull Analysis Reliability Analysis - Predictions, Testing and Standards 12
S Is there a minimum industry standard for PpK ? Statistical Analysis Tools, Techniques and SPC 8
K What are the minimum requirements for Process Validation (Software)? ISO 13485:2016 - Medical Device Quality Management Systems 5
C Battery Powered Beauty Products minimum Legal Certifications Requirements CE Marking (Conformité Européene) / CB Scheme 7
D Minimum requirements/experience/qualifications to be head of quality Career and Occupation Discussions 6
R Minimum Essential Receiving Inspection (M.E.R.I.) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
J Minimum number of parts to do an attribute gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
I Minimum and Maximum Validation Batch Size Requirements Qualification and Validation (including 21 CFR Part 11) 3
A Minimum Number of Parts for Attribute (Go / NoGo) Data Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
N Minimum Design factor for CE Marking for machinery CE Marking (Conformité Européene) / CB Scheme 2
J Minitab Sample Size Calculation: 1 Sample t vs Minimum Sample Size for Means Using Minitab Software 3
G Why for a Shewhart chart the minimum feasible value for APL is 2401 units? Statistical Analysis Tools, Techniques and SPC 8
A Minimum Testing Requirements for a Clear Protective Equipment Barrier (Class II 510K) Other US Medical Device Regulations 1
V Critical Characteristics - Capability for a Minimum Specification APQP and PPAP 11
BradM What is the minimum size chamber for mapping? ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom