Consolidation of Testing Methods

Southern Cross

Involved In Discussions
#1
One of the things that the company I work for is trying to do is consolidate testing methods down to a smaller number than is currently used. I've been asked to check some of the data that's been produced. It looks like this:

Product Manual Tecam Sunshine
C410096 9' 20" 9' 20" 9' 30"
C410014 5' 30" 5' 00" 5' 30"
C260011 29' 30" 31' 30" 33' 48"
C200333 30' 30" 31" 30" 32' 06"
C200301 61' 00" 63' 30" 65' 40"
C200301 52' 30" 54' 00 57' 30"
C260013 5' 00" 4' 40" 5' 20"
C220023 24'10" 24'25" 25'00"
C200037 19'40" 20'00" 20'25"
C010003 6'00" 6'00" 6'10"
C220022 8'35" 9'00" 9'10"
C280020 28'25" 28'20" 28'30"
C220013 26'30' 26'45" 26'30"

The results are times, for each of the products tested. Manual, Tecam and Sunshine are three different test methods.

What kind of analysis that I can do? The number seem to say to me that the results are broadly similar. If they had done replicates, then it seems to look to me like a Gage R&R test. But they didn't..
 

Southern Cross

Involved In Discussions
#3
These are gel times. The product is mixed with a hardener, then (under constant conditions) the clock is started, stopping when the product gels. Manual means that the operators is expected to check the test at regular intervals. The other two methods have instruments which accomplish the same thing automatically.

Not sure what you mean by a reference table?
 
#4
I plotted your data to compare. My first thought was that the data provided is too sparse to allow for any solid conclusion; like you mention having replicates would be helpful. The general impression is however that it seems that the three methods yield practically identical results, except perhaps for two products where there are some differences, although not large. These differences don?t seem to depend of the gel time, but perhaps there is some ?hidden variable? in these two products that we don?t know about and that may have been caught by the different test methods.
 
Thread starter Similar threads Forum Replies Date
N Reusing the ID of superseded forms in a Document Consolidation exercise? Document Control Systems, Procedures, Forms and Templates 4
N Does Debt Consolidation Really Help Your Credit Score? Coffee Break and Water Cooler Discussions 7
Sidney Vianna More Registrar Consolidation Registrars and Notified Bodies 33
N Contract Review Consolidation - Two different manufacturing sites Contract Review Process 2
M Talk about steel producer consolidation: World News 0
D Criteria for Certification Consolidation Document Control Systems, Procedures, Forms and Templates 3
D Consolidation of Quality Manuals Quality Management System (QMS) Manuals 3
T Mold Limits for Microbiology Testing Other Medical Device Related Standards 3
S Orthopedic implant sterility testing Medical Device and FDA Regulations and Standards News 1
H Independence between the development and testing IEC 62304 - Medical Device Software Life Cycle Processes 6
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Testing criteria - where to place Design and Development of Products and Processes 2
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
B In house NIOSH pre Testing accepted by NIOSH? US Food and Drug Administration (FDA) 1
M Bacteriostasis/Fungistasis Testing Other Medical Device and Orthopedic Related Topics 6
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 9
B NIOSH Approval for Surgical N95 Respirators - Required testing US Food and Drug Administration (FDA) 2
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
lanley liao Purchase Acceptance Criteria - Tensile testing Oil and Gas Industry Standards and Regulations 2
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Cochlear Implant Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
JoCam Electrical Testing for Japan, PSE or CB Scheme Other Medical Device Regulations World-Wide 0
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
P Testing cloud-based backups IT (Information Technology) Service Management 7
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Comparing data from destructive testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Flammability testing Reliability Analysis - Predictions, Testing and Standards 0
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
K When is Bioburden Testing Required? Other Medical Device Related Standards 7
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 3
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
P Flammability Testing of Aircraft Interior Materials Federal Aviation Administration (FAA) Standards and Requirements 0
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 8

Similar threads

Top Bottom