Sampling is the selection of a representative portion of the population to make inferences about the entire population. In pharmaceutical manufacturing, samples are drawn from different stages of the process for both controlling process parameters and assessing product quality.
Instead of waiting until production is in full swing, the sampling process allows you to catch discrepancies or failures to meet your specification standards early on in the process. This can prevent a large number of wasted resources, including both time and money.
Within the following sections, we will explain to you how to set your sampling plan as part of the process when creating your Manufacturing Master Record
Data Ninja uses AQL "General Inspection Levels" as the parameter, and these values are already integrated into the system as pre-existing values. what this means is that Data Ninja will do the math based on your:
- Lot size (quantity)
- Inspection levels/sampling plan (ie. Reduced I, Normal II, or Tightened III)
- Defect classifications (ie. Critical, Major, or Minor)
- AQL level corresponding to inspection & defect levels.
The user will be guided by the system (Data Ninja) to complete the inspection process, as soon the production starts manufacturing.
Based on the information above a plan can be generated for sampling and acceptance limit.
To proceed and add the sampling plan, go to the corresponding Bill of Materials, and click the Sampling Plan tab, then click the "Add Sampling Plan" button.
Set AQL levels
Proceed and set the levels based on your company regulations, severity levels vary depending upon the business of the company.
add Defect Categories
Defects are required to be categorized depending on companies' regulations, For example, the Critical defects category encompasses all defects that can be Hazardous or unsafe for the individuals using them.
To add these defects click the dropdown arrow as the video below shows, select if existing or type the defect and select add new.
Can I update my sampling plan?
YES, this is possible until BOM getting use to schedule a new Manufacturing Batch. This action will locked the Manufacturing Master Record and can only be updated by revising the MMR use Creating a BOM copy for directions.
Updated 4 months ago