Inspection Sampling Plan

Sampling is the selection of a representative portion of the inventory of an item to make inferences about the entire inventory. 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 when inventory is received. This can prevent a large number of wasted resources, including both time and money.

👍

BOM Sampling Plan

AQL can be set up on both Incoming Inspections as well as BOMs, but sampling plan settings do not cross over. Sampling plans set up on an Inspection Configuration will only apply to received materials, and plans set up on a BOM will only apply to production records. The setup on each page is fairly similar, see the BOM Sampling Plan page for exact steps.

Acceptable Quality Level (AQL)

DataNinja uses AQL "General Inspection Levels" as the parameter, and these values are already integrated into the system as pre-existing values. This means that DataNinja will do the math based on your:

• Lot size (quantity)
• Inspection levels/sampling plan (i.e. Reduced I, Normal II, or Tightened III).
• Defect classifications (i.e. Critical, Major, or Minor).
• AQL level corresponding to inspection & defect levels.

The user will be guided by the DataNinja to complete the inspection process after receiving inventory.

Based on the information above, a plan can be generated for sampling and acceptance limit. Below is an example for a lot of 250,000 on AQL II.

Setting Up AQL in DataNinja

Acceptable Quality Limit/Level (AQL) is the amount of deviation allowed in a product and is set on a per-part (or per-inspection configuration) basis. This built-in feature allows another level of quality control to make sure the product is at your exact specifications. DataNinja's Quality Sampling Plan feature will automatically calculate the amount of product that needs to be inspected, as well as how many of the inspected items can fail before a 100% inspection is required.

📘

Inspection Configurations

Since the Quality Sampling Plan is associated with an Inspection Configuration, multiple parts can use the same sampling plan without having to set it up on part-by-part basis if the Configuration is set as a template. See the Incoming Inspection page for details on creating a template and applying it to multiple parts.

If the Configuration is not set as a template, the sampling plan will need to be manually created on each part.

From a Blank Inspection

From the Parts page, double click on the part (raw material, sub-assembly, or finished good) or click 'View' in the Actions column. Open the Inspection tab, and click 'Create Blank Inspection' if an Inspection Configuration is not already on the part.

If there is an Inspection Configuration on the part already, and you cannot edit any fields, jump to the "On a Template" section of this page.

When you start creating a blank inspection on a part, the first step is to create an approval step. In the new aside, set the name for the approval step, then specify which role(s) will need to complete the approval and hit "Save".

Note that all assigned roles will have to sign Inspections before they are considered complete.

The sidebar will close and you should now see the approval step on the page.

See the Incoming Inspection page for details on building out approval steps on an Inspection Configuration, or leave it blank for now.

Click 'Add Quality Sampling Plan' to expand the section, then click 'Add Sample Plan' and select an AQL option.

In the new aside, enter any instructions, and click 'Add Sampling Plan'. Then specify the AQL and any categories, and repeat as many time as needed. Multiple categories can be added to each Critical/Major/Minor sampling plan.

Once all desired severity levels have been added, click "Save" and the sampling plan will show on the Maintain Part page.

Sublot Count or Not?

If you select "Yes" to sublot count, the sample size will be based off the number of labels. If you select "No" then the sample size will be based on the total quantity produced in a batch instead. Choose whichever option best fits your needs and sampling requirements.

Enable Override (Optional)

If 'Yes' is selected, then users with the correct permissions can override the AQL requirements for this inspection/sampling.

On a Template

If the part you are viewing is using a template Inspection Configuration, you will not be able to edit any inspection fields on the part. You will need to open the template on the Inspection Configuration page and make the necessary changes there. Click on the box with an arrow next to the name of the inspection to open the template.

Click 'Add Quality Sampling Plan' to expand the section, then click 'Add Sample Plan' and select an AQL option.

In the new aside, enter any instructions, and click 'Add Sampling Plan'. Then specify the AQL and any categories, and repeat as many time as needed. Multiple categories can be added to each Critical/Major/Minor sampling plan.

Once all desired severity levels have been added, click "Save" and the sampling plan will show on the Inspection Configuration page.

Sublot Count or Not?

If you select "Yes" to sublot count, the sample size will be based off the number of labels. If you select "No" then the sample size will be based on the total quantity produced in a batch instead. Choose whichever option best fits your needs and sampling requirements.

Enable Override (Optional)

If 'Yes' is selected, then users with the correct permissions can override the AQL requirements for this inspection/sampling.