Uploaded by Nurul Amira Khalid

SOP Quality Assurance

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Standard Operating Procedure for Acceptable Quality Level.
Department: Quality Assurance
1. Purpose: To lay down the standard procedure for an acceptable quality level for semifinished cartridge to evaluate physical attributes before packing.
2. Scope: This sop applicable to all Boldpod products manufactured at factory level.
3. Responsibility:
3.1 Concern QA officer and production officer shall be responsible for sampling.
3.2 Concerned production officer shall be responsible for raising requisition format for AQL.
3.3 Quality Assurance officer shall be responsible for performing the Acceptable quality level
(AQL), section head production shall be responsible for checking, and section Head Quality
Assurance shall be responsible for authorizing the same.
3.4 Head production and Head QA shall be responsible for compliance with this SOP.
4. Precaution: Wear hand gloves and a nose mask before sampling and while performing
Acceptable quality level (AQL).
5. Procedure for Acceptance Quality Level (AQL):
5.1 For empty cartridge: Sampling and checking for any defect cartridge shall be done upon
receiving, tagging the arrival batch according to date and testing empty cartridge before
start the production.
5.2 After Liquid Filling: Random pick up from production line 2 cartridges each flavour every
day.
5.3 After complete production: Reserve 2 box of every week batch to be tested after 7 days.
5.4 Reserve 2 boxes to be tested after 30days.
5.6 Daily report updates on percentage defect and type of defect.
5.6 Weekly report on tested result.
6. Acceptance Criteria:
6.1 Each batch should meet the acceptance criteria as per the sampling plan for a
routine inspection.
6.2 If the regular inspection fails, urgent report to upper-level management either to do
changes before product enter the market / deliver to customers, then each batch shall
meet the acceptance criteria of tightened inspection.
7. Classification of defects for AQL in case of Cartridge and Device:
7.1 Critical defects:
•
Psychical Damage– Cartridge and device
•
Battery function - Device
•
Mislabel - incorrect identification of a product
•
Leaking
•
Burn Taste - This includes visual control, composition analysis, flavour testing and nicotine
content testing
7.2 Major defect
•
Broken – Internal part damage
•
Surface specks– foreign, extraneous particles or contaminants, which can be wiped or blown
off.
•
Chipped– separation or dislodging
•
Mottled– improper distribution of color
7.3 Minor Defect:
•
It does not affect the use of the product for its indicated purpose but distracts from the
appearance of the products, cosmetic.
8. Packing Defect for AQL:
8.1 Major defects Packing:
•
Incorrect count filled into containers
•
Incorrect identification of a product
•
Improper sealing of containers
•
Illegible coding of batch details
•
Undesired marks, hair, or spots showing on the first instrumentation on the surface / within
the surface
•
Minor defects
•
Adhering surface spots on closures/containers
•
Loose / slanted, crimpled/stained label
Approved By:
Received By:
MOHD REDZUAN BIN RAHIM
MANAGING DIRECTOR
AHMAD AKMAL FAIS BIN HARUN
QUALITY ASSURANCE MANAGER
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