Sampling for Internal Test based upon ISO 2859-1, G-I

N

nurhakim

#1
Hi Cove,

I have this scenario in the workplace, and I need your opinion:

We carry out internal test for a medical device, bag wise, based upon ISO 2859-1, G-I.
In one particular bag, we have 7200 pcs. According to G-1, we sampled 80 pcs. Our AQL is 1.0, Accept:2, Reject:3.

We split the test into two, visible defect test and water test. If, during first test i.e. visible defect test, we found 2 pcs of defect, we have 78 pcs left. For water test, our sampling plan is still 80 pcs. Do we need to add another 2 pcs for water test or can we use the 2 defective samples? And what if the defective samples are not fit to mount on the water test apparatus.

Thanks.
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Staff member
Super Moderator
#2
technically as long as the visual defects can't effect the water test you could use them. However, its simpler to just add 2 more units that are not visually defective
 

David-D

Involved In Discussions
#3
I don't know the specifics of this ISO but since it sounds like your two defects aren't independent (you say they couldn't be leak tested which I'd generally classify as a defective part), I wouldn't be comfortable with pulling out some defects in your sample based upon the visual and then doing the leak.

Think of it this way: I have a sample of 80 parts with 4 that leak, two of which are so malformed that they'd also fail a visual inspection. If I do the visual first then I pull out the two worst ones (just passing the visual AQL) and then I do the leak test and get 2 more failures (just passing the leak test). If I switched the order of inspeftions though, you'd get 4 leak test failures, rejecting the lot/bag for leak issues. It sounds like your defects aren't independent so you are basically pre-screening your sample before you test it.

I think you need to leak test the visual rejects or just count them as leak failures automatically, otherwise you are in actuality tampering with your sample - it would be like (in an edtreme case) pulling a sample of 100 parts, sorting through them to get rid of any that look bad and then pulling your sample from that - your sample is not representative of the original population from which it was drawn.

David
 
Thread starter Similar threads Forum Replies Date
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
T ISO 13485: 2016 Internal Audit - Is sampling on projects allowed? ISO 13485:2016 - Medical Device Quality Management Systems 6
T Sampling for an Internal Testing Laboratory General Measurement Device and Calibration Topics 4
B Statistically Sound Data Sampling Technique for Internal Audits Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
C Internal Audit Sampling Plans - Determining Internal Audit Sample Size Internal Auditing 45
E Internal Process Audit Sampling using MIL-STD-105-E - 500 operators on 3 shifts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
R Reduced sampling plan for sterial products APQP and PPAP 0
A ISO 2859-1 - 9.3.3.2 Switching score - Sampling Plans and PPM AQL - Acceptable Quality Level 0
R BS EN 12060:1998 - Zinc and zinc alloys Method of sampling Specifications Manufacturing and Related Processes 4
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
8 Activity Sampling Exercise Lean in Manufacturing and Service Industries 11
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 1
B AS9100D Sampling Plan AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
Nicole Desouza Sampling plan for a customer who wants AQL 1.0 (per ANSI Z1.4) AQL - Acceptable Quality Level 5
V How to interpret AQL sampling tables AQL - Acceptable Quality Level 5
A AQL sampling bags of parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
C Applying Weibayes to Attribute sampling Reliability Analysis - Predictions, Testing and Standards 0
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
E Sampling for capability studies for variables and attributes Capability, Accuracy and Stability - Processes, Machines, etc. 4
O Statistical justification of sampling size in V&V tests ISO 13485:2016 - Medical Device Quality Management Systems 5
M Sampling Plan for Alumin High Pressure Die Castings Manufacturing and Related Processes 0
E Sampling plan for orthopedic implant - Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
S Inspection/sampling economics Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S How to make a Sampling Plan - Conveyor belts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
J AQL for Effectiveness Check - What AQL tiers to use on this type of sampling? Nonconformance and Corrective Action 9
N The question asks about sampling plans and AQL Reliability Analysis - Predictions, Testing and Standards 5
S Help develop sampling plan for prototype samples (medical devices) Statistical Analysis Tools, Techniques and SPC 7
A ISO 2859 Single Sampling - Clarification regarding the sampling table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Are zero defect sampling plans relevant to AS9120B Distributor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R DCMA Sampling of CSI Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Sampling method that is representative of the devices supplied by that distributor EU Medical Device Regulations 5
M Zero Defect Sampling Plan Standards Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
L ISO 2859-2 LQL sampling plan linked to %confidence/%reliability Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K Sampling Plan for transparent tubular plastic parts from 32 different cavities Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M ISO / ASTM standards for Sampling Plans for Medical Devices Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
N Sampling for stability studies - Class II surgically invasive devices Other Medical Device and Orthopedic Related Topics 1
S Surveillance Sampling Test - Determining Sample Size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
A AQL Sampling Plan SOP / WI - Medical Device Industry Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
B IATF 16949 Cl. 8.6.6 - Acceptance Criteria - Zero Defects Attribute Data Sampling IATF 16949 - Automotive Quality Systems Standard 2
C Sampling of Class IIb Implantables under EU MDR - Assessments to the EU MDR EU Medical Device Regulations 4
R Technical Files Sampling Rule defined in NBOG 2009-4 EU Medical Device Regulations 2
J Sampling Plan Questions from the CQE Practice Exam Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
M Sampling Plan for for Chemical Analysis Testing of Medical Devices EU Medical Device Regulations 3
V Sampling Plan for Destructive Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2

Similar threads

Top Bottom