SOP for sampling of Packaging materials.

This Document describes (Standard Operating procedure) SOP for sampling of Packaging materials.

SOP for sampling of Packaging materials.

I. Purpose & Scope:

• The purpose of this SOP for sampling of Packaging materials.
• This Standard operating procedure shall be applicable for sampling of Packaging materials.

II. Responsibilities:

• All Quality Assurance personnel shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

Procedure for sampling of packaging materials: 

• At receipt of packing material, Goods Receipt Note (GRN) is received from stores.
• The Q.C. chemist will enter all relevant details of Goods Receipt Note in Packing Material register Refer Annexure I.
• Ensure that all packaging materials are received from approved vendor list.
• Carry the things as per Annexure II and proceed for sampling.
• Ensure that sampling of packaging materials shall be done as per procedure.
• Check the Physical condition of the consignment and record the observations the sampling check list of packaging materials refer Annexure III.
• Check all the details from manufacturer / supplier against the received material.
• Select the number of samples to be sampled based on the total quantity received in a lot As per Annexure IV. Sample collection to be spread uniformly over the number of containers received in a lot.

From the containers to be sampled, the material is checked for attributes and variables.

Attributes:

• These are parameters like color, shade, printability, presence of dirt and stain, alignment, presence of spots etc. which are visually based and indirectly affect the packaging requirement

Variables: 

• These are the parameters like dimension, grammage, thickness etc. that have continuous dimensions. They have an infinite number of possibilities.
• Affix the “Under test” labels to each pack of consignment.
• Affix the Sampled labels preferably to the pack on the right corner below “Under Test” labels.
• Check the required numbers of samples for attribute check and as per ANSI Z 1.4 as per Annexure V. Attribute checks shall be performed at respective quarantine area only and almost similar number of units from each container shall be collected. The sample shall be examined as per AQL against approved standard for attribute parameters (critical, major and minor defects) that are provided in packaging lab, refer Annexure VI.
• Collect the required number of samples as per Annexure VII for variable check and put in a self sealing poly bag with label “ Sample for analysis” having appropriate details of consignment and is taken to packing material quality control laboratory. The samples for variable check are retained from the samples for attribute check.
• The remaining samples are put back in the consignment.
• Record the sampled quantity, attribute check quantity, variable check quantity in the sampling observation sheet in the respective report format.

Sampling of Aluminum Foil and PVC / PVDC / Forming foil:

• Check the consignment details for correctness of the details mentioned on GRN.
• In case of discrepancies intimate to QA Manager.
• Carryout the sampling of packaging materials from each consignment separately one after the other.
• After completion of the sampling of each lot close each container of the lot with BOPP tape having or tie with cable and take out and store in the under test area.
• Sampling of packaging materials i.e. Carton, Label, Leaflet, Polythene bags, and corrugated box etc.
• In case of Secondary packaging material carry out the sampling activities in their respective quarantine area.
• Prior to sampling of packaging materials, clean the number of container to be sampled with the help of dry duster.
• Wear the hand gloves and mouth mask during sampling of packaging materials activity.
• After completion of the sampling of packaging materials from each lot close each container of the lot with BOPP tape or tie with cable and store them in their respective quarantine area.
• This sampling procedure shall not be applicable for tertiary packaging material like shipper, pad, partition and corrugated tray for these specified items only one unit shall be collected as a sample to carry out the test.
• Ensure that sampling of packaging materials shall be done as per standard procedure.

 

IV : Annexure :

Annexure	Format Name
Annexure I	Packing material register.
Annexure II	Sampling Kit
Annexure III	Sampler check list of packaging material
Annexure IV	Sampling plan for attribute check
Annexure V	Sampling plan (AQL CHART).
Annexure VI	Critical, major and minor defects in packaging materials
Annexure VII	List of samples for analysis

Annexure I

Packing Material Register

Sr. No.	Date of Receipt	GRN NO.	Name of Packing  Material	Qty. Received	Supplier Name	Sample Qty.	A.R. NO.	Sampled By	Remark	Checked By

Note : Sampling of packaging materials shall be done as per written instructions.

Annexure II

Sampling Kit

Sr. No.	Items
1	Appropriate no. of  “under test” labels
2	“Sampled” labels
3	“Sampled for Analysis” labels
4	Appropriate no. of small poly bags/bigger poly bags
5	Scissor/Cutter
6	Standard Operating Procedure for sampling of Packing Materials
7	Reference copy of current Approved Vendor List
8	Fasteners
9	BOPP tape

 

Annexure III

Sampling Checklist of Packing materials

1	Name of Item :
2	Name of manufacturer / Supplier:
3	Item Code:			GRN No.:
4	Lot No.			Quantity verified for attribute check:
5	No. of packs / boxes received:			No. of packs / boxes sampled:
6	Qty per box / pack:			Quantity Sampled:
7	Total Quantity Received:			Date of Sampling:
Physical Condition of Consignment
8	Nature of containers/Boxes	Wooden/ polythene Bag / Gunny Bag / Paper Bag / Corrugated Others…….………………
9	Physical condition of consignment	OK/ Not OK  (Torn / Seal open / Damage)
10	Source of Material	Approved vendor / other
11	Analytical Report (COA)	Received / Not Received / Not applicable
12	Cleaning Of Surrounding area of consignment	Ok / Not Ok
13	Proper Consignment label Affixed by Party	Yes / No
14	After sampling resealing of boxes done	Yes / No
15	Remarks:
Sampled by: (Sign / Date)			Checked by: (Sign / Date)

Note : Ensure that Sampling of packaging materials shall be done as per procedure.

Annexure IV

SAMPLING PLAN FOR ATTRIBUTE CHECK ANSI 1.4

Table I : Single Normal Procedure (AQL chart)

LOT SIZE	GENERAL LEVEL
	I	II	III
2 to 8	2	2	3
9 to 5	2	3	5
16 to 25	3	5	8
20 to 50	5	8	13
51 to 90	5	13	20
91 to 150	8	20	32
151 to280	13	32	50
281 to500	20	50	80
501 to1200	32	80	125
1,201 to3,200	50	125	200
3,201 to 10,000	80	200	315
10,001 to 35,000	125	315	500
35,001 to 150,000	200	500	800
150,001 to 500,000	315	800	1250
500,001 and OVER	500	1250	2000

 

REMARKS:-

GENERAL LEVEL I    – Applicable for Container, jar, BOPP tape, Polybag, Shipper and other.

GENERAL LEVEL II – Applicable for Blister Foil, Glassine Foil, PVC, PVDC, Aluminium                                       Tagger seals.

GENERAL LEVEL III – Applicable for Carton, Catch cover, Labels and Leaflet.

 

Annexure V

SAMPLING PLAN (AQL CHART) ANSI 1.4

Table II : Single Normal Procedure (AQL CHART)

SAMPLE SIZE	Critical (AQL level 0.10)		Major (AQL level 1.0)		Minor (AQL level4.0)
	AC	RE	AC	RE	AC	RE
2	0	0	0	0	0	0
3	0	0	0	0	0	1
5	0	0	0	0	0	1
8	0	0	0	0	1	2
13	0	0	0	1	1	2
20	0	0	0	1	2	3
32	0	0	0	2	3	4
50	0	0	1	2	5	6
80	0	0	1	3	7	8
125	0	1	2	4	10	11
200	0	1	3	6	14	15
315	1	2	5	8	21	22
500	1	2	7	11	21	22
800	2	3	14	15	21	22
1250	3	4	21	22	21	22
2000	5	6	21	22	21	22

 

Note:  AC:  Acceptance

RE:  Rejection

 

Annexure VI

CRITICAL, MAJOR AND MINOR DEFECTS IN PACKAGING MATERIALS

1.0    DEFECTS IN CARTONS:

Type:

• Reverse tucks in flap.
• Locked bottom.

 

CRITICAL	MAJOR	MINOR
Dimension Text matter(Labelled claim) Puncture of text matter Blank	Grain Direction Letter Smudging Scumming Cross Pasting Deguming Grammage. Shade variation Bottom locking	Inside sticking Ink spots Tunnelling of lamination Hicks

 

2.0    DEFECTS IN ALUMINIUM FOIL:

Tamper Type:

1) Hard (20 &25µm)

2) Soft (30 & 40µm)

 

CRITICAL	MAJOR	MINOR
Dimension Text matter(Labelled claim) Cell filling Pin holes Grammage of heat sealing lacquer or LDPE Blank	Colour shade Loose winding Creases Cuts Scratches Smudging Letter smudging	Dents Thickness

3.0    DEFECTS IN LABELS:                                                                                      

Type:

1) Plain

2) Self sticking

CRITICAL	MAJOR	MINOR
Grain direction Dimension Text matter(Labeled claim) Puncture of text matter Blank	Shade variation Scumming Letter  smudging	Grammage

4.0    DEFECTS IN LEAFLETS:

CRITICAL	MAJOR	MINOR
Text matter(Labeled claim) Puncture of text matter Blank on one side or both sides	Dimensions Paper quality Scumming Letter smudging	Folding

 5.0    DEFECTS IN PRINTED SHIPPERS:

CRITICAL	MAJOR	MINOR
Dimension Text matter (Labeled claim) Puncture of text matter Bursting strength Number of piles	Letter smudging Scumming Grammage of the paper Rusted staples	Number of staples Flute ratio

 6.0    DEFECTS IN UNPRINTED SHIPPERS:

CRITICAL	MAJOR	MINOR
Dimension Bursting strength Number of piles	Grammage of the paper Rusted staples	Number of staples Flute ratio

 

7.0    DEFECTS IN VIALS:

CRITICAL	MAJOR	MINOR
Damage	Moulding	Colour Variation

 

8.0    DEFECTS IN PLUGS:

CRITICAL	MAJOR	MINOR
Uneven Cutting	Size Variation	Colour Variation

 

9.0    DEFECTS IN SEALS:

CRITICAL	MAJOR	MINOR
Peeling of Lacquer Damage	Shade Variation Peeling of Lacquer Damage	Improper cutting

 Annexure VII

LIST OF SAMPLES FOR ANALYSIS

Sr. No.	NAME OF MATERIAL	SAMPLES TO BE WITHDRAWN FOR ANALYSIS
1	Carton/Catch Cover/Catch Box	10
2	Printed Label	10
3	Leaflet	10
4	Container/Jar	05
5	Poly bags	10
6	BOPP Tape	1
7	Shipper/Partition/Plate	1
8	Aluminium Tagger Seal	10
9	Aluminium foil	1 meter
10	PVC film	1 meter
11	Alu-Alu  forming foil	1 meter
12	Sticker Roll Label	10 Nos.
13	Rubber Plug	20 nos.
14	Flip off Aluminium Seal	20 nos.
15	S.W.F.I.	40 nos.
16	Silica Bag	10 nos.
17	Shrink Roll	1 meter
18	LDPE drum	1 no.
19	Applicator	10 nos.
21	Plastic Tray	10 nos.