Performance - Expected "overall" performance - From Minitab

Marc

Marc

Fully vaccinated are you?
Leader
Expected "overall" performance: The expected "overall" performance values quantitatively represent the actual process performance. The expected values are calculated using the overall sample variance.

Also see: Observed performance definition.
 
M

mt1719

Process capability:
What is the observed performance in Minitab?
The formula minitab uses helps anwer the question:
For
i) Observed Performance PPM < LSL = 1,000,000 * ((number of observations < LSL) / n)

ii) Observed Performance PPM > USL = 1,000,000 * ((number of observations > USL) / n)

Observed Performance Total = sum of (i) and (ii):yes:
 
Marc

Marc

Fully vaccinated are you?
Leader
It happens. Nothing wrong with adding to an old thread. Lots of people read through old threads. It is always appreciated if they have something of value to add.
 
A

Allattar

:)
I just couldnt see the question, and was a little confused by the dates. Ill blame it on mid friday afternoon sleepiness.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Marc Definition Expected "overall" performance - Definition - Process Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
J Help with Mintab concepts: Expected "overall" performance vs. Observed performance Six Sigma 5
Z Shelf life automatically set to 6 months when no device performance shelf life data provide Medical Device and FDA Regulations and Standards News 5
E Clause 15.4.2.1 d) - Loss of ESSENTIAL PERFORMANCE IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Dazzur Sharing Suppliers Performance Data with Supplier. Supplier Quality Assurance and other Supplier Issues 6
E ISO 17025 Key Performance Indicators (KPIs) ISO 17025 related Discussions 5
L Supplier Performance when your supplier is also the customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
L Supplier performance evaluation Supplier Quality Assurance and other Supplier Issues 8
K SGS Certification - Advice on their Performance Service Industry Specific Topics 9
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
S Performance Qualification and Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna IATF 16949 News IATF Performance Complaint Management System (IATF CMS) within the IATF Database IATF 16949 - Automotive Quality Systems Standard 4
malasuerte Performance of ISO 9001 certified vs. non-certified manufacturing companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R SaMD Performance Testing US Medical Device Regulations 5
S Supplier performance required to be reported to supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Transfer of Performance specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Do clinical performance studies for IVDs need to be conducted in a member state? EU Medical Device Regulations 2
A Do clinical performance studies for IVDs need to be conducted in a member state? CE Marking (Conformité Européene) / CB Scheme 0
I Post-market surveillance and Post-market performance follow-up for in vitro diagnostic medical devices EU Medical Device Regulations 0
D Key Performance Indicators / KPI Review IATF 16949 - Automotive Quality Systems Standard 11
Ed Panek Notified Body Performance Trending Poll EU Medical Device Regulations 8
Aymaneh IVDR and Performance Evaluation Plan EU Medical Device Regulations 2
Aymaneh Summary of safety and performance (SSP) IVDR 2017/746 EU Medical Device Regulations 1
N Pre-Clinical Performance Testing Design and Development of Products and Processes 3
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
A How to measure the performance of ISMS? IEC 27001 - Information Security Management Systems (ISMS) 3
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G What does performance specification include? US Food and Drug Administration (FDA) 1
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
MaHoDie IVDR and Performance Evaluation Plan CE Marking (Conformité Européene) / CB Scheme 2
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Performance of high shear mixer (or rapid mixing granulator Qualification and Validation (including 21 CFR Part 11) 4
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
B Four Key Performance Indicators for Continual Improvement (Dec. 3 2019) [Deleted] Training - Internal, External, Online and Distance Learning 2
F 5520A High Performance Multi-Product Calibrators General Measurement Device and Calibration Topics 0
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
O Performance Measurement ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 1
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom