Question:
Are there recommended AQLs (critical, major and minor defects) for packaging material (primary and secondary) for the Pharmaceutical Industry?
Thank you
Response:
Though there are no recommended AQLs (or LTPD) for packaging materials, some industry standards have begun to surface. The following table is a guideline that I have seen used successfully for a risk based approach to sampling. Based on the severity and criticality of the packaging materials, these guidelines can be adjusted up to down per your risk management process. Utilizing a c=0 sampling plan based on the binomial distribution, the sample size can be calculated using the following formula.
|
|
Primary |
Secondary |
|||||
|
Confidence (%) |
Reliability (%) |
Sample Size |
Confidence (%) |
Reliability (%) |
Sample Size |
||
|
Critical |
99.5 |
99 |
527 |
99 |
97 |
151 |
|
|
Major |
99 |
97 |
151 |
97 |
95 |
68 |
|
|
Minor |
97 |
95 |
68 |
95 |
90 |
28 |
|
I hope this assists you.
Steven Walfish
Secretary, U.S. TAG to ISO/TC 69
ASQ, CQE
Principal Statistician, BD
http://statisticaloutsourcingservices.com
For more about this topic, please visit ASQ’s website.