# Kindly help me to understand MSA Acceptance Level

#### mohaniman

##### Mohan Selvakumar
Dear Team,

Kindly help me to understand the Acceptance level

Linearity
stability
Bias
Kappa

#### Miner

##### Forum Moderator
Staff member
Linearity: t-values for the slope coefficient and intercept coefficient must be less than the critical t-value. Zero line must fall within the confidence limits of the regression line.

Stability: The plotted points must be in control for the duration of the study.

Bias: A calibration or the Linearity study will address Bias.

Kappa: I am not an expert on Attribute Agreement Analysis. Hopefully someone else will add a comment.

#### Marc

##### Fully vaccinated are you?
Staff member
Thanks, Miner. I appreciate your help here.

I'll add a few Forum Searches. They're broad (single word) searches so some unrelated discussions will come up:

Linearity

Stability

Bias

Kappa

And don't forget to check out the Thread Topic Tag links at the top of this thread.

#### Bev D

##### Heretical Statistician
Staff member
Super Moderator
mohaniman - could you clarify what about the acceptance criteria you would like to understand? for example are you interested in:
• what they are?
• why they are at those levels?
• what do you need to do if you don't meet the acceptance criteria?

In teh meantime I can tell you that for Kappa agreemetn studies there are various guidelines that have been published by various sources. Some are shockingly low...The more critical the defect in terms of severity of effect, the higher the Kappa score should be. *I* personally use a 95% - 99% level for acceptance dependign on teh severity.

Unfortunately many of these 'acceptance criteria' are not scientifically derived, they are loose 'rules of thumb' not tied to consequences of false acceptance or rejection of product.

#### Jim Wynne

Staff member
Just FWIW, I once submitted a PPAP that included an attributes study that indicated 100% agreement between operators. It was rejected on the grounds that the result exceeded 30%.

#### Bev D

##### Heretical Statistician
Staff member
Super Moderator
Awesome! Absurdity abounds

B 5 Why help needed Please kindly review Problem Solving, Root Cause Fault and Failure Analysis 15
J Kindly Review my Control of Non-Conforming Product Procedure Nonconformance and Corrective Action 8
L Kindly Review our new Environmental Policy Miscellaneous Environmental Standards and EMS Related Discussions 4
Business Process Map - Kindly review my process mapping of my company Process Maps, Process Mapping and Turtle Diagrams 5
S Method to Rate an External Supplier - Kindly assist me Supplier Quality Assurance and other Supplier Issues 14
A Readiness review - Kindly give me some pointers on how to face this audit IATF 16949 - Automotive Quality Systems Standard 16
K New to automotive QA - 8D vs Drill Deep - Kindly explain to me what 8D is Nonconformance and Corrective Action 9
Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 9
Help needed with locating conector Design and Development of Products and Processes 0
CER: can "state of the art" help to make up for literature search on equivalant devices? EU Medical Device Regulations 1
Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
Can someone help me explain P-Value with a simple word please? Capability, Accuracy and Stability - Processes, Machines, etc. 11
Help on formulating a LP minimization problem Manufacturing and Related Processes 2
Help with understanding Process Controls Manufacturing and Related Processes 7
Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
Need help with analysing a survey on minitab Using Minitab Software 1
Help me improve the definition for internal PPM Manufacturing and Related Processes 3
Help: QFD House of Quality Quality Tools, Improvement and Analysis 1
New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
Class medical device (MDD) - Classification help EU Medical Device Regulations 1
A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
% Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
Thanks for the help Coffee Break and Water Cooler Discussions 0
Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
Burn out - Tips to help combat QC burnout Career and Occupation Discussions 19
Measurement system analysis - Can you help me about implementation MSA for CMM device Manufacturing and Related Processes 2
New to FAIR, need help in filling it out AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8