QMS-150 Classification of defects for incoming packaging components

1.0 DOCUMENT OWNER

Technical/Quality Manager

2.0 PURPOSE

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

This SOP is linked to QMS-145 Classification of Defects in Manufacturing Operation.

3.0 SCOPE

This SOP explains the 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) 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) as per WAR-090 Sampling Inspection and Release of Packaging Materials.

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 (Appendices 1, 2 and 3) 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.

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

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 QAR.

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 created sub lot.

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

6.0 TYPE OF PACKAGING DEFECTS & THEIR AQL:

6.1 Critical Defects (AQL: 0~0.25%)

A defect that would result in hazardous or unsafe conditions for individuals using, maintaining or depending upon the product.

Following is list of Critical Defects typically found in incoming packaging lots:

Delivery:

–    Delivery damaged or contaminated and the component can’t be used

–    Bag/Sack is cut, crooked or ragged and the component can’t be used

–    Splice tap on safety seal

Appearance:

–    Internal or External surface foreign matter, rust or corrosion, which can interact with products.

Printing:

–    Missing or unreadable printing which may be detrimental for the consumer

–    Incorrect printing

6.2 Major Defects (AQL: 0.4~0.65%)

A defect that is likely to result in failure or that would materially reduce the usability of the product for its intended purpose.

Following is list of Major Defects typically found in incoming packaging lots:

Delivery:

–    Seals not present

–    Missing polyethylene liner bag

–    Missing, illegible or incorrect pallet markings.

–    Missing plastic protection bag

–    Wrong delivery quantity

–    Not labelled with site order no / code no / component description

 Appearance:

–    Pin hole, pitting, scuffing, streak, nicks, embedded foreign matter, splits.

–    Cracks, chips, blisters

–    Water damaged

–    Gloss free area missing

–    Component is not the correct shape (square, triangle, rectangular etc.)

–    Visual defect which affects the use or elegance

–    Anti-counterfeit labels are not in the quantity specified, not positioned as per artwork / are easily removed.

Dimension:

–    Core inside diameter is under or exceed specification

–    Dimensions are too large or too small

–    Wind is too loose or too tight

–    Volume is under or exceeds specification

–    Incorrect angle (bottles)

Printing:

–    Colour is out of colour standard

–    Registration marks are not correct or in the exact position

–    Barcode / EAN / Pharmacode is incorrect, unreadable or in the incorrect position

–    Colour misplaced / not used as per specification

–    Tape test failed

–    Missing colour

–    Spelling is incorrect

–    Edge Barcode is not showing

–    Missing or unreadable printing which may not be detrimental for the consumer

–    Incorrect printing

Assembly:

–    Glue line becomes unstack during testing

–    Cartons not opening correctly

–    Bottles threads malformed

–    Uneven base

–    Folded incorrectly

–    Not Uni Bi-oriented as per specification

–    Knifing / cutting is not as per artwork

–    Doesn’t assemble properly

Materials

–    Material is different than specified

–    Mixed / Incorrect ID number (PM#) used

–    Incorrect type of board / paper / foil / PVC / PVDC / Shrink wrap

–    Component split / break / crack during inspection

–    Negative ID using Pyridine spot test

6.3 Minor Defects (AQL: 1.0~4.0%)

A defect that is not likely to materially reduce the usability of the product for its intended purpose.

Following is list of Minor Defects typically found in incoming packaging lots:

Delivery:

–    Missing Certificate of Compliance.

–    Stacking higher than 1.4m

–    Not in rows or stacked on their sides.

–    Laid flat on top of rows

–    Wrapping / Bands used

–    Shippers are overfilled and bulging

Appearance:

–    Visual defects which do not affect the use or elegance

–    Clarity is not as per specification

–    Flashes / Loose Flashes (bottles and caps)

–    Torn, distorted or soiled

Dimension:

–    Diameter is under or exceed specification

–    Thickness is out of specification

Printing:

–    Roll marking faded / missing or off pitch

–    Packaging material code incorrect or not in the exact position

–    Not sequentially numbered

–    Missing ID with black marker (joins on foil)

–    Defaced

Assembly:

–    Incorrect board direction

–    Internal closure coating is missing, putted or flaking

–    Metal sliver unattached or attached at one end only, 1/8 longer or shorter

–    Missing or partial tube liner

–    Glue line is slightly out of parallel

–    Cuts are marginally crooked or ragged but the component can be used

–    Not affixed as per artwork

–    Not packed in shippers

–    Joins are not as per specification or exceed allowed quantity

–    Flags not present

Weights:

–    Weight is out of specification

Materials

–    Adhesive type is not according to specification

–       Not coated as specification