Reporting 24/7/365 Reliability Data - MTBF Data for Customer Advertising

B

Baggie

#1
Can I have opinions on this please,

I have a supplier who has asked me for advice and I'm struggling, it goes something like this.
"We are selling a product where we want to publish MTBF data!! "
"We do know what we sold, when."
"We don't know operational time (in users stores, supply chain etc)

"Can we take sample data from customers where we know 24/7/365 useage and extrapolate for the whole population."

My stats head says yes,
My engineers head says no, because 24/7/365 implies that start up / close down has been minimal (max stress); and that may not be typical of the population.

Is there a way of taking the 24/7/365 data and applying a confidence factor to determine a figure that is "robust"??

You will have gathered by now that I'm a QA person and not a reliability engineer, so apologies in advance for the dumb nature of the question !
 
Elsmar Forum Sponsor
M

Murphys Law

#3
There are some major inputs missing from this analysis:-

- What is the medium from which the program data is read from boot up? Is it external flash memory?
 
B

Baggie

#4
Sorry, i should have explained that this was a question "in principle".
This could be a mechanical assembly or a piece of software. Surely the same fundamental principles apply.
 

D Scott G

Starting to get Involved
#5
Greetings;

Just a quick input of my $.02

I have always been interested in making people quantify a Status

Say a capability study during normal operation for at least a 30 day period that has an acceptable CPK

How is their MTBF measured and to what standard, are you equipped to measure those criteria at your facility? Without those you cannot make a logical decision as to your path forward.

Scott
 

Miner

Forum Moderator
Staff member
Admin
#6
I recommend this website by Larry George. Look in the left frame under freeware for the K-M Reliability estimation. There is an article and a freeware Excel spreadsheet that will produce Kaplan Meier MTBF estimates from Warranty data with no assumptions about the duty cycle.

Larry has published a monograph for ASQ's Reliability Division on this topic. I have found the broom charts especially useful for highlighting reliability issues unique to a specific time period.
 
J

janedoe

#7
Can I have opinions on this please,

I have a supplier who has asked me for advice and I'm struggling, it goes something like this.
"We are selling a product where we want to publish MTBF data!! "
"We do know what we sold, when."
"We don't know operational time (in users stores, supply chain etc)

"Can we take sample data from customers where we know 24/7/365 useage and extrapolate for the whole population."

My stats head says yes,
My engineers head says no, because 24/7/365 implies that start up / close down has been minimal (max stress); and that may not be typical of the population.

Is there a way of taking the 24/7/365 data and applying a confidence factor to determine a figure that is "robust"??

You will have gathered by now that I'm a QA person and not a reliability engineer, so apologies in advance for the dumb nature of the question !
Cool....perfect application for the use of a Nevada matrix. The only company I know of that has a program for it is "Reliasoft" Weibull ++....I think they are on version 7.
 
Thread starter Similar threads Forum Replies Date
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
L Adverse Event Reporting New Zealand Other Medical Device Regulations World-Wide 11
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
MDD_QNA How to deal with FDA after not reporting anything for several years Other US Medical Device Regulations 14
D Accident reporting categories Occupational Health & Safety Management Standards 1
T Trend Reporting under the EU MDR EU Medical Device Regulations 7
M Informational TGA – Medical device incident reporting (MDIR) guide Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF proposed document – IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Anne Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Mandatory reporting requirements for hospitals Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Statement on agency’s efforts to increase transparency in medical device reporting Medical Device and FDA Regulations and Standards News 0
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 2
T Why are most companies have Quality reporting to Engineering or Operations and not to CEO ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
Marc European universities dismal at reporting results of clinical trials - 2019 Other Medical Device Regulations World-Wide 0
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 3
M (How To) Getting Data From Vision Machine To Reporting Software Misc. Quality Assurance and Business Systems Related Topics 0
F Vigilance Reporting - Requirements for manufacturer Field Corrective Actions (FCAs) Other Medical Device Regulations World-Wide 5
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
G Reporting measurement uncertainty for custom items Measurement Uncertainty (MU) 2
Pmarszal ISO 19011:2018 - Risk Based Approach for planning, conducting and reporting of internal audits Internal Auditing 8
J MDR reporting and CAPA thoughts? Classifying Complaints on Risk 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
L Calibration Accuracy In Relation To Reporting General Measurement Device and Calibration Topics 1
S Adverse Event and Serious Adverse Event Reporting - Korea Other Medical Device Regulations World-Wide 4
R Reporting Profile of a surface with U modifier Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q U.S. Agents - Responsibility for reporting adverse events to the FDA Other US Medical Device Regulations 10
J Japan AE (Adverse Event) Reporting Requirements Japan Medical Device Regulations 5
S MDS (Material Declaration Sheet) Reporting for Volatile Solvent in oil RoHS, REACH, ELV, IMDS and Restricted Substances 1
shimonv Reporting Medical Device Changes with Annex V/VII EU Medical Device Regulations 1
L MDR (Medical Device Reporting) under 21 CFR Part 803 Other US Medical Device Regulations 5
Q Medical Device Reporting In US/ EU/ Canada Customer Complaints 6
N Notification of Changes to a Class I Medical Device - Reporting Requirements EU Medical Device Regulations 4
C Software for trending and reporting particulate testing Quality Assurance and Compliance Software Tools and Solutions 2
P Using Bugzilla as a Quality Reporting Tool Quality Assurance and Compliance Software Tools and Solutions 11
JoCam Incident Reporting MHRA (Medical & healthcare regulatory agency) EU Medical Device Regulations 3
A Reporting Corrective Action System Performance Metrics Quality Tools, Improvement and Analysis 1
S Medical Device Reporting SOP (Standard operating procedure) example Other Medical Device and Orthopedic Related Topics 1
V ICH Q3 - To "Include OR Not to Include" impurities below reporting threshold General Measurement Device and Calibration Topics 2
A What are the obligatory medical device reporting timelines for AIMD devices ? ISO 13485:2016 - Medical Device Quality Management Systems 2
6 Spreadsheet for Health and Safety Reporting - Template Occupational Health & Safety Management Standards 6
N Notified Body excessive reporting onto Competent Authorities via the Eudamed database ISO 13485:2016 - Medical Device Quality Management Systems 7
L OTD (On Time Delivery) Tracking and Reporting Misc. Quality Assurance and Business Systems Related Topics 13
goetzkluge Incidents at work causing mental ill health - Reporting & Assessment Occupational Health & Safety Management Standards 5
B Changes in Medwatch Reporting Requirements Other US Medical Device Regulations 5
Similar threads


















































Top Bottom