Strategies to Mitigate Fails in DV Testing

#1
Dear Forum,

I'd like to discuss possible strategies when 1 of 59 samples fails a single DV test. The sample size was choosen according 95% / 95% confidence and reliability per risk assessment. One strategy is to test additional 36 samples to achieve 95% / 95% with one fail.

Are there other strategies?

I highly appreciate your thoughts.

Andy
 
Elsmar Forum Sponsor
#3
Hi indubioush,

many thanks for your answer. In this case, a design change is not possible because we use an on the market medical device as base and only do little modifications. The feature that fails was on the base device, is not related to our modification, and the test was required by the applicable standard.
 

yodon

Leader
Super Moderator
#4
There are probably too many factors to consider that we don't know to give any advice (beyond what @indubioush already mentioned). Why was 95/95 chosen? What's the risk (to the patient/operator/environment) of the failure occurring? (Presuming this failure is addressed in your risk analysis, it would seem that the probability should be rather high!) What are the modifications you make & why can't you 'cover' the failure?
 
Thread starter Similar threads Forum Replies Date
B Sampling strategies/techniques for software QA Software Quality Assurance 3
G DFMEA buy-in strategies for Design Engineers APQP and PPAP 22
K IoT, AI, Big Data and National Strategies of Other Countries (in your country, do you have any?) IEC 27001 - Information Security Management Systems (ISMS) 12
D Strategies for reducing software documentation burden IEC 62304 - Medical Device Software Life Cycle Processes 10
A Supplier Quality Management Strategies - Semiconductor Assembly and Test Services Supplier Quality Assurance and other Supplier Issues 6
J Strategies for 'Testing' any Operating System Quality Assurance and Compliance Software Tools and Solutions 1
Q Using Risk Communication Strategies to leverage Audit Reporting Misc. Quality Assurance and Business Systems Related Topics 11
D Strategies for Going In Blind - My employer is probably confused why I'm here Misc. Quality Assurance and Business Systems Related Topics 11
G Policy Awareness Strategies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Control of NCM: segregation strategies QS-9000 - American Automotive Manufacturers Standard 1
S Strategies for reducing Sampling on incoming bulk material - low volume, ingots Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
qualprod Examples to mitigate risk from Covid ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Antiviral Mask or Mask to Mitigate or Control Corona Virus Manufacturing and Related Processes 29
F Risk = Likelihood * Severity - Can we mitigate the Severity? Occupational Health & Safety Management Standards 44
N Variable Data Test Never Fails Capability, Accuracy and Stability - Processes, Machines, etc. 9
N Switch to 100% inspection when lot fails sampling? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T Faulty PCBA - Our Testing Fails but Manufacturer's Testing Passes Supplier Quality Assurance and other Supplier Issues 2
B Separate Clinical Trials in the US and the EU - When one fails - question US Food and Drug Administration (FDA) 3
B Issue CAR (Corrective Action Request) When KPI Fails to meet Goal Quality Manager and Management Related Issues 8
R To SCAR or not to SCAR? First Article with a new supplier fails Supplier Quality Assurance and other Supplier Issues 3
K If auditor fails to consider something which is material to the outcome of the audit? Internal Auditing 19
L When a tool fails calibration how do you track what product was checked with it? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 31
Marc When a Supplier Fails World News 6
Stijloor Industry aid fails in the Senate World News 18
H Wavetek 9100 fails self-test - Need Service Manual source General Measurement Device and Calibration Topics 18
C Microscope Reticule Calibration - Fails 1x metric, passes 3x imperial General Measurement Device and Calibration Topics 3
A Linearity and Bias Study - Bias Study fails - Seeking advice Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
J Help with Gage R&R Study - Spreadsheet fails when all 10 samples are the same size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
D AMS 2750C - Guidance under AMS 2750C for when a furnace fails a uniformity survey? Various Other Specifications, Standards, and related Requirements 2

Similar threads

Top Bottom