Statistics/sampling plan for medical device

#1
Hi Gents,

I am looking for some help with regard to statistics/sampling plans etc. Traditionally we have use ANSI Z1.4 as our statistical basis for sampling (AQL sampling at the end of batch). I am looking for alternatives (with references) since the sampling of medical devices such as pen injectors is an expensive operation and these devices should already have under-gone design verification studies at the manufacturer. Any ideas are appreciated.
 
Elsmar Forum Sponsor
#3
Are you doing a study of attributes or variables? What is your tolerance for "false positives"?
Not sure what you mean by false positives...but we listed all the attributes and categorize them into minor/major/critical in our SOP and following AQL. But the problem is these devices are very expensive and we could lose a lot of products if strictly following AQL at the current batch size.
 

Jim Wynne

Leader
Admin
#5
Not sure what you mean by false positives...but we listed all the attributes and categorize them into minor/major/critical in our SOP and following AQL. But the problem is these devices are very expensive and we could lose a lot of products if strictly following AQL at the current batch size.
It's not clear to me what the question is. Are you looking for a sampling plan that will make it easier for you to accept defective product? Please explain the types of defects you're looking for and why you think the current plan is inappropriate.
 
#6
It's not clear to me what the question is. Are you looking for a sampling plan that will make it easier for you to accept defective product? Please explain the types of defects you're looking for and why you think the current plan is inappropriate.
Hi Jim, we currently use AQL level II which results in 500 products being sampled which are undergoing destructive testing. The goal is not to accept defective product but to find a reasonable way to reduce the total lost due to destructive testing.
 

Jim Wynne

Leader
Admin
#7
Hi Jim, we currently use AQL level II which results in 500 products being sampled which are undergoing destructive testing. The goal is not to accept defective product but to find a reasonable way to reduce the total lost due to destructive testing.
This is the first mention that what you're doing is destructive. I asked what sort of defects you're looking for. Now I'll ask how many you typically find. Help us to help you.
 
#10
This is the first mention that what you're doing is destructive. I asked what sort of defects you're looking for. Now I'll ask how many you typically find. Help us to help you.
Injectable pen product. Looking for volumes from each click, number of clicks/total volume, analytical and micro testing. The product is still in PV stage, not clear the amount of defect typically find. If I have that number, I probably can establish a new AQL through a risk assessment. But the issue is we do not want to lose so many products at this stage so potentially looking for an alternative approach.
 
Thread starter Similar threads Forum Replies Date
S Statistics and Sampling - Accounting for Failed Tests Statistical Analysis Tools, Techniques and SPC 10
A Statistics Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J Design Verification Testing and Statistics Reliability Analysis - Predictions, Testing and Standards 3
K CQT Exam - Statistics Professional Certifications and Degrees 4
N Simple statistics questions on labor data Statistical Analysis Tools, Techniques and SPC 2
S Statistics and / or Forecasts on medical products exports from China Other Medical Device and Orthopedic Related Topics 1
Richard Regalado What could go wrong with information: Ransomware statistics and facts (2018 to present) IEC 27001 - Information Security Management Systems (ISMS) 0
I Good resources for learning statistics (quality engineering related) Statistical Analysis Tools, Techniques and SPC 10
qualprod Statistics - Where to start in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ninja Visitor Statistics - How to see a poster's stats easily? Elsmar Xenforo Forum Software Instructions and Help 3
D How do you use statistics in your job Statistical Analysis Tools, Techniques and SPC 6
J Excellent Resource on Statistics / Lean / Six Sigma Book, Video, Blog and Web Site Reviews and Recommendations 2
V Accelerated Learning and Simulations / Scenarios - Statistics Statistical Analysis Tools, Techniques and SPC 0
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
V Statistics - Designs - Differences between Orthogonality and Confounding Using Minitab Software 5
M Statistics Question - What percent falls above 105? Statistical Analysis Tools, Techniques and SPC 2
A Assessing a Preventive Maintenance Strategy - Reliability or Maintenance Statistics Reliability Analysis - Predictions, Testing and Standards 2
T Metrics and Statistics for Improvement - Easy to implement Statistical Analysis Tools, Techniques and SPC 4
C Statistics equation to determine the number of samples in a lot Statistical Analysis Tools, Techniques and SPC 8
A ASQ CQE statistics training in Australia? Training - Internal, External, Online and Distance Learning 2
E Online Degrees and Graduate Certificates in Statistics Training - Internal, External, Online and Distance Learning 1
AnaMariaVR2 Guide to Microsoft Excel for Calculations, Statistics, and Plotting Data Excel .xls Spreadsheet Templates and Tools 11
C Basic Statistics Template .xls Document Control Systems, Procedures, Forms and Templates 0
S Statistics in Check/Replicate Analysis - HPLC Assay (Sample Duplicates) Statistical Analysis Tools, Techniques and SPC 1
R Student Question - Help needed with statistics questions Statistical Analysis Tools, Techniques and SPC 6
M The Statistical Meaning of "Muddy Middle" - Statistics Terminology Statistical Analysis Tools, Techniques and SPC 6
B Descriptive Statistics where the Data Type is Text? Using Minitab Software 4
R Industry Statistics on the benefits of Quality Management Systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Jim Wynne xkcd on Statistics and Mainstream Media Funny Stuff - Jokes and Humour 2
A R using RExcel - Non GUI Statistics Program Statistical Analysis Tools, Techniques and SPC 1
Wes Bucey Job recovery? or "statistics don't lie, people do" Career and Occupation Discussions 37
G Statistics Question from Production and Operations Management Course Statistical Analysis Tools, Techniques and SPC 3
O Information on the extent of Statistics in the Six Sigma Green Belt Exam Professional Certifications and Degrees 9
J Gage R&R Module for R (Statistics Program) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
T Survey or Statistics on the use of OHSAS 18001 Worldwide Occupational Health & Safety Management Standards 66
T Survey or Statistics on the use of the AS 9100 Standard Worldwide AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
H Elsmar Cove Statistics Found Online Coffee Break and Water Cooler Discussions 2
Chennaiite Quotable Quotes - Statistics Funny Stuff - Jokes and Humour 10
S Statistics of Gage R&R & Boundary Specifications Statistical Analysis Tools, Techniques and SPC 15
K Sample Statistics on HR (Human Resources) Key Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
bio_subbu FDA released guidance on use of Bayesian statistics in Clinical Studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
O Weighting Problems (Statistics) - Weight distribution for a machine setup Capability, Accuracy and Stability - Processes, Machines, etc. 5
S "Human Error" statistics Quality Manager and Management Related Issues 3
S ASQ CSSBB Exam & Knowledge of Statistics Professional Certifications and Degrees 3
J Are there PPM statistics kept by Industry Manufacturing and Related Processes 4
Marc Battery-Life Statistics After Work and Weekend Discussion Topics 4
F Error in Minitab (no statistics can be calculated with these data) Using Minitab Software 10
O The Basis of %GRR (% Gage R&R) and other Statistics - Minitab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 21
V Management Review Meeting - Statistics for Customer Complaints and Non Conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T The use of Statistics at a Medical Device Manufacturer US Food and Drug Administration (FDA) 16

Similar threads

Top Bottom