ISO 2859-2 LQL sampling plan linked to %confidence/%reliability

#1
Although this is my first post to this forum I have been reading this treasure trove of high quality information for a while now and want to express my gratitude to this community. Thank you for all your guidance and advice!

Then, onto my situation:
- we produce small LOT's (50 to 100 a batch) of disposable, sterile class IIa medical devices
- we have implemented a destructive sample check to verify the quality of these products after manufacturing & sterilisation
- we had implemented a ISO 2859-1 AQL based sample plan (so a inspection by attributes and AQL levels based on Risk Management) BUT we got feedback from our notified body that for design verification and validation a ISO 2859-2 LQL sampling plan linked to %Confidence/%reliability levels coming from Risk Management.

My question being:
From what I have understood the required sample size for a attributes inspection with c=0 (all samples should pass the test) can be calculated as:
n=ln(1-confidence)/ln(reliability)
(e.g. 95% confidence /90% reliability would result in n=29)
However: how as n is not linked to a LOT size how can one link this to LQL levels?
 
Elsmar Forum Sponsor

v9991

Trusted Information Resource
#3
i was further reviewing certain articles...

ref. slide 20 :- Acceptance Quality Limits and Visual Inspection
• Understand the sample size is unrelated to population size (in most situations).

The Effect of Lot Size
The "discrimination" or protection provided by a sampling plan depends primarily on the number of units inspected and the acceptance number. Lot size has only a minor effect limited to the case when 10% or more of the lot is inspected.
Since Type-B OC curves represent worse case, sampling plans selected based on Type-B OC curves can be used to inspect any lot regardless of size. When selecting statistically valid sampling plans, it is not necessary to use different sampling plans for different lot sizes. A better strategy is to select one sampling plan based on the protection it provides, i.e., its OC curve.

so the emphasis is more on thinking through on selection of sampling plan, vs the lot size.:agree:
 
Thread starter Similar threads Forum Replies Date
C Sampling - ISO 16269-6 vs ISO 2859 Other ISO and International Standards and European Regulations 0
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
A ISO 2859-1 - 9.3.3.2 Switching score - Sampling Plans and PPM AQL - Acceptable Quality Level 0
A ISO 2859 Single Sampling - Clarification regarding the sampling table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Accept/Reject (Ac/Re) Numbers (ISO 2859-1) Confusion Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
L Table 2-A from ISO 2859-1 - AQLs from 150 to 1000 Reliability Analysis - Predictions, Testing and Standards 2
L What changed in Amendment 1:2011 in the ISO 2859-1:1999? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N Use of arrows in ISO 2859-1 Table 1 and 2-A sampling plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
N Sampling for Internal Test based upon ISO 2859-1, G-I Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A MIL STD 105 D or ISO 2859-2? Receiving Metal Sheets Quality Tools, Improvement and Analysis 6
S Military Sampling Plan 105E vs. ISO 2859-1 AQL - Acceptable Quality Level 2
I Alpha and Beta in the Sampling Plan for ISO 2859 & ISO 3951 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
D Disposable Medical Device Sampling Plans per ISO 2859-1 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
P ISO 3951 vs. ISO 2859 for Medical Device Components ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 2859-1 or Ansi ASQ Z1.4 in using AQL or AOQL - Need Help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Difference between MIL-STD-105 and ISO 2859 AQL - Acceptable Quality Level 2
E Which sampling table (ISO-2859) must I use on different lot sizes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D ISO 2859 - Probability that sample size is sufficient Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
0 AQL Sampling Plan based upon ISO 2859 AQL - Acceptable Quality Level 1
D ISO 2859 to set up a Sampling Program in a Food Manufacturing Company Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
Q What are the differences between ANSI Z1.4, ANSI Z1.9, and ISO 2859-2? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Special Inspection Level 3 (S-3) per ANSI Z 1.4 & its relationship with ISO 2859-1 AQL - Acceptable Quality Level 1
P Medical device functional test - ISO 2859 or 3951 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
G Sampling plans for large quantities along lines of ISO 2859-1:1999 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
R Sampling Plans - ISO 2859-1: 1999 - How to calculate the switching score? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
I Asian Supplier Sampling Plans besides MIL-STD-105? My thought was ISO 2859? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
H Incoming Inspection Sampling Plan ISO 2859-1/ ISO 2859-2 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
S Developing sampling plans based on AS1199, ISO 2859-1 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
T ISO 2859-3 - Skip-lot sampling procedures - Unauthorized Inspection Frequency Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
T I would like to implement ISO 2859 standard for Incoming (Receiving) Inspection Other ISO and International Standards and European Regulations 3
C Software or Excel .xls spreadsheet to calculate sample size and the AQL - ISO 2859-1 AQL - Acceptable Quality Level 2
Stuart Andrews Sampling Plans (ISO 2859-1)(BS6001-1) - Probability of defects within a lot Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 3
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 17025 Lead Assessor Training ISO 17025 related Discussions 0
H Active Implantable Medical Devices - ISO 14708 and EN 45502 Other Medical Device Related Standards 0
L ISO 10993-18 vs ISO 18562-4 Other Medical Device Regulations World-Wide 4
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
D ISO 14001 Finding - Missing Safety Data Sheets ISO 14001:2015 Specific Discussions 2
J ISO 17025 Calibration Other Medical Device Related Standards 2
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
I ISO 9000 Where to Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 81
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom