How many Samples are required in Attribute Data MSA Studies?

B

berseak

#1
How many sample of MSA attribute in MSA 4th edition .

The auditor said 50 part. But I read the manual not identify.
(In MSA 3rd edition page 126 have wording "a ramdom sample of fifty parts)

Thank you.
 
Elsmar Forum Sponsor
B

Barbara B

#2
Re: How many sample of MSA attribute?

The sample size depends on the process characteristics and the method. There are two pages on which the required sample size in an attribute measurement system study is mentioned in MSA 4th:

page 140-141 /risk analysis method (kappa coefficient):
Sample size should be established with respect to the process capability, the higher the capability, the more samples needed. In the example for a capability of Pp=Ppk=0.5 (corresponding to a 13% nonconformance rate) the sample size was set to n=50.

page 145 / analytical method:
"Eight parts should be selected at as nearly equidistant intervals as practical.[...] The eight parts must be run through the gage, m=20 times, and the number of accepts ,(a), recorded."

Hope this helps,

Barbara
 
Thread starter Similar threads Forum Replies Date
K How Many Samples to send for Chemistry Testing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
G How many samples you require to test during PQ for validation of a equipment? ISO 13485:2016 - Medical Device Quality Management Systems 1
R Is it possible to randomly select samples from 1 column to many column Using Minitab Software 2
J How many attribute samples from a lot with zero defects? Statistical Analysis Tools, Techniques and SPC 2
R How many samples do we submit for PPAP? APQP and PPAP 2
R How many process maps are adequate for a company for IATF 16949? Process Maps, Process Mapping and Turtle Diagrams 17
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
G How many Design FMEAs do you have? FMEA and Control Plans 4
V Literature search over how many years? EU Medical Device Regulations 8
S How many tester quantity we need on the line based on the cycle time and peak volume Manufacturing and Related Processes 3
M R&R Studies - how many? per product? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J How many majors is one company allowed ? IATF16949 Manufacturing and Related Processes 16
M Summative evaluation: how many sample per participant? IEC 62366 - Medical Device Usability Engineering 5
J How many hours for a NB to review Technical Documentation? EU Medical Device Regulations 6
T Too many NC's/ Deviations and CAPAs galore Nonconformance and Corrective Action 10
B How many nonconformances have you received on average during IATF audits? General Auditing Discussions 27
G Too many customer complaints Customer Complaints 16
I How many gauges in a Go/No Go Gauge? General Measurement Device and Calibration Topics 7
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
Watchcat How Many Notified Bodies are "Enough" Already? EU Medical Device Regulations 23
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
M Informational From RAPS – Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn Medical Device and FDA Regulations and Standards News 0
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
G Measuring customer parts on a CMM - How many decimals to report to the customer? ISO 17025 related Discussions 28
J Supplier choice limitation - Many of them dont have PSCR, VDA or even ISO 9001 VDA Standards - Germany's Automotive Standards 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
D IATF 16949: Do we have too many processes? Are they all the same? Registrars and Notified Bodies 7
D QMS Performance Based on how many NCRs were generated month to month Nonconformance and Corrective Action 8
S How many QMS processes and procedures? ISO 13485:2016 - Medical Device Quality Management Systems 2
L How many of you are Certified to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 12
G How many Uncertainty Measurements for Micrometers and Calipers? Measurement Uncertainty (MU) 3
R How many Corrective Action Request can be Issued by DCMA for a single issue? Nonconformance and Corrective Action 2
A Training Program Help - Old docs, new docs, so many docs... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M How many Pieces to Test - Sterility Testing USP EU Medical Device Regulations 2
P Are we an outlier for so many variations of Change Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M SPC with many data points from one dimension Statistical Analysis Tools, Techniques and SPC 16
S How many times do you have the term 'Requirements' in your Quality Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L How many working hours to required to implement ISO 14001 ? ISO 14001:2015 Specific Discussions 6
B ISO/TS16949 Internal Auditing - How many auditors? Internal Auditing 4
R Training Production Employees When We Have SOOO Many SOPs Training - Internal, External, Online and Distance Learning 9
P Scope Extension Audit - How many days? Do I audit all AS9100 requirements? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J How can I manage Occurence Rates in FMEA efficiently when I have many processes? FMEA and Control Plans 9
V How many times the quality agreement has been invoked? ISO 13485:2016 - Medical Device Quality Management Systems 3
C How to document many document control systems with one Document Control Procedure? Document Control Systems, Procedures, Forms and Templates 6
A How many laboratories are accredited to ISO 17025 in the USA? ISO 17025 related Discussions 5
L How many ISO Standards are there and time allowed for Closing NCs? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom