WAR-110 Classification of Defects for Iincoming Packaging Components

1.0 DOCUMENT OWNER

Warehouse / Quality Manager.

2.0 PURPOSE

Define the classification of defects found during the inspection of incoming packaging components.

3.0 SCOPE

This SOP explains the Acceptable Quality Limit (AQL) levels and categories of defects for all incoming packaging components received and tested at a GMP site.

It also determines the responsibility levels for the acceptance or rejection when an Out of Specification (OOS) result occurs.

4.0 RESPONSIBILITY

It is the responsibility of the Incoming Goods Inspectors to identify and evaluate the extent of a defect when inspecting a packaging component.

It is the responsibility of the Quality Assurance Manager to accept or reject the defective packaging component that falls outside its AQL level.

5.0 PROCEDURE

All deliveries of packaging components undergo thorough sampling and inspection against artwork and the Packaging Material Specification (PMS).

When a defect is found during the inspection:

5.1 Determine the type of problem, defects or failure for any characteristics of the component whether it’s related to the delivery, appearance, dimension, printing, assembly, weight or material.

5.2 Refer to the Tables of Defects (Appendix A) and find the listed defect that corresponds to the type of problem determined.

5.3 If the defect is listed in:

5.3.1 Appendix 1 – It is a Critical defect: a defect that would result in hazardous or unsafe conditions for individual using, maintaining or depending upon the product.  (AQL of 0.0%).

5.3.2 Appendix 2 – It is a Major defect: a defect that is likely to result in failure or that would materially reduce the usability of the product for its intended purpose.  (AQL of 0.4%).

5.3.3 Appendix 3 – It is a Minor defect: a defect that is not likely to materially reduce the usability of the product for its intended purpose.  (AQL of 1.5%).

5.4 Then, evaluate the extent of the problem based on the Acceptable Quality Level (AQL) for that component and defect (refer to Appendix B, C and D).

For example: for a delivery of 20,000 cartons, according to the sampling plan.

The level of defects allowed per sample of packaging components will be:

5.5 If a component is found to have a defect or a non-conformance to specification and falls outside of its AQL then a deviation will be raised (refer SOP QMS-035 Pharmaceutical Deviation Report System). The lot will be rejected unless exemption to accept the lot is granted by Quality Assurance and this is documented in the deviation report.

5.6 If a component is found to have a defect or a non-conformance to specification but falls within its AQL, then:

5.6.1 If this defect or non-conformance is determined to be Major, the component will be approved to proceed for use in production.

5.6.2 If this defect or non-conformance is determined to be Minor, the component will be approved to proceed for use in production.

In both cases, no deviation will be raised.

5.7 Where only part of a delivery is to be rejected the lot will be sub-lotted.

5.8 Write in the History Supplier Folder that the batch is approved but, in the comment section, write that a part of the lot. (i.e. knifes number…) has been rejected under the creation of sublot.

5.9 The next delivery from the same supplier will have to follow a tighter inspection plan.

APPENDIX A:

CRITICAL DEFECTS (AQL OF 0.0%)

MAJOR DEFECTS (AQL OF 0.4%)

MINOR DEFECTS (AQL OF 1.5%)

APPENDIX B: SWITCHING SAMPLING INSPECTION LEVELS

1. Tightened Inspection to Normal Inspection

When tightened inspection is in effect, normal inspection will apply for the next delivery when five (5) consecutive lots of packaging materials have been considered acceptable from a given supplier for a given class of products.

2. Normal Inspection to Tightened Inspection

When normal inspection is in effect, tightened inspection will apply for the next delivery when two (2)  out of five (5) consecutive lots of packaging materials from the same supplier have been rejected for a  given class of products (only original lots considered, not re-submitted lots).

3. Normal Inspection to Reduced Inspection

When normal inspection is in effect, reduced inspection will apply to the subsequent delivery if the previous ten (10) or more consecutive lots of packaging materials from the same supplier have been approved on normal inspection for a given class of products.

4. Reduced Inspection to Normal Inspection

When reduced inspection is in effect, normal inspection will apply if any of the following occur:

– A lot of packaging material is rejected.

– When the previous delivery of packaging materials from an approved supplier occurred more than 12 months ago.

– If a lot of packaging materials is tested on reduced inspection and found to exceed the accepted level of defects but is below the reject level, it will be accepted but the next delivery will be tested on normal inspection.

If Quality Assurance advises that normal inspection should be applied for the given supplier.

APPENDIX C: Acceptable Quality Limit, AQL

Acceptable quality level (AQL) is defined as the “quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance.” (Ref. ISO 2859)

Once a manufacturer has studied their process capabilities, the repeatability of what they make, and the statistical ability to trap and capture defects, this is then used to set the Upper limit on any specific defect type. It is then linked to the US Military statistical sampling plan as the process to set the number and frequency of sampling goods to capture the defects from a given production size.

The definitions of the type of defect and the Acceptable maximum level we use are those set by the US Plastic Closure Manufacturers Associations. The below is a simplified version describing the AQL process.

The AQL tells you how many defective components are considered acceptable during random sampling quality inspections. It is usually expressed as a percentage or ratio of the number of defects compared to the total quantity.

It is important to note that AQLs are NOT specifying a quantity of any defect that will always be present in these manufactured goods. They identify that when an issue happens in manufacture. It is the largest quantity of a defect a customer could experience at one point in time.

Key points to remember:

– The acceptable quality level (AQL) is the worst quality level that is tolerable for a product.

– The AQL is used in conjunction with the sampling plans from ISO 2859 to determine

–           The number of cartons to be opened

–           The sample size

–           The number of defects that are acceptable / not acceptable.

– The AQL differs depending on the type of defect being sampled. Critical defects (ones that may represent a greater risk) will have a lower AQL than those considered as minor defects.

FOR EXAMPLE:

A particular lot of product is found to have short-shot during molding.

AS 1199.1-2003 tells us that:

– For a given lot size with 100 cartons, 10 cartons chosen randomly will need to be sampled.

– For a lot size of 250 000, 800 pieces over those 10 cartons sampled are inspected. i.e., random @80 pieces to be picked from 10 cartons.

– For an AQL of 0.4 (at a normal inspection level), the lot will be rejected if 8 or more defective items are found during sampling. If 7 or fewer defective items are found, the lot is accepted.

– This acceptance criterion will change if the inspection level is set at tightened or reduced.

– AQLs for various nonconformities are defined below and/or can be listed separately in the finished items specification (FIS) as agreed with the customer.

1 NONCONFORMITY DEFINITIONS

1.1 Critical (AQL: 0~0.25%, accumulated critical nonconformities: 0.25%)

A critical nonconformity is:

a. one which judgment and experience indicate is likely to result in hazardous or unsafe conditions for individuals using, handling, or storing the product;

b. one which qualified judgment and experience indicate will cause the product to be in violation of any applicable federal and/or state law or federal regulation.

1.2 Major (AQL: 0.4~0.65%, accumulated major nonconformities: 0.65%)

A major nonconformity is:

a. one other than Critical, which would result in obvious failure of the product to fulfil its intended purpose;

b. one other than Critical, which, though unrelated to function, is likely to reduce the saleability of the product; i.e., the major appearance nonconformity;

c. A packing, packaging, or labelling nonconformity, other than Critical, which is likely to result in either product damage or transport, storage, or inventory error;

d. One other than Critical, which judgment and experience indicate will impair the function of downstream automatic processing equipment.

1.3 Minor (AQL: 1.0~4.0%, accumulated minor nonconformities: 4.0%)

A minor nonconformity is:

a. one which has no significant effect, discernible or otherwise, on the product’s function, but does prevent the product from being what it is supposed to be;

b. one which is not likely to reduce the product’s saleability but does indicate poor workmanship;

c. one other than Critical or Major which, though related to the function of the product, does not adversely affect the usability and/or saleability of the product; e.g., a process control nonconformity discernible only to the manufacturer and knowledgeable inspectors;

1.4 OVERALL accumulated nonconformities (max AQL: 4.65%)

APPENDIX D: SAMPLING PLAN: (ISO 2859)