Quality Control

QUALITY GUIDELINE CONTENTS

GENERAL INFORMATION
1.1 Introduction
1.2 Quality Policy

QUALITY STANDARDS
2.1 General instructions
2.2 Physical Quality Criteria
2.3 Chemical Quality Criteria
2.4 Electrical Quality Criteria
2.5 Functional Quality Criteria
2.6 Visual Quality Criteria

PRODUCT DEVELOPMENT & LAUNCH
3.1 General Instructions for Specifications
3.2 Specification Change Process

PRODUCT MAINTENANCE
4.1 Incoming Material Inspection & Defect

Management
4.2 Supplier Qualification and evaluation
4.3 Shelf Life Policy

PRODUCT MONITORING
5.1 Finished Goods Inspection
5.2 Sample submission to
5.3 Sample Shipping Instructions
5.4 Quality Measuring Equipment and Methods

PROCESS CONTROL
6.1 Change Over Procedure
6.2 Manufacturing Quality Plan
6.3 QUIP ProcedureQUIP

QUALITY MANAGEMENT
7.1 Hygiene management
7.2 Consumer/Customer Complaint Handling Procedure
7.3 Serious Quality Incident Management
7.4 Traceability
7.5 Training

QUALITY STANDARDS

Purpose
Clearly understood essential quality parameters for products
Acceptable Quality Limit for defects detected during lot inspection
Applicable to finished product
Parameters concerned with the critical quality characteristics of the product
Examples:

Physical	Chemical	Electrical	Functional	Visual
1. Length 2. Diameter 3. E-Liquid weight	Chemical components of vapor	1. Cartomizer resistance 2. Battery capacity	1. Device activation on puffing 2. LED lightingLED 3. Rechargeability	1. Cracks/scratches 2. Peeling stickers 3. E-liquid leakage

More detailed QC factors hiden by business rules secretly

All defects/deviations are assigned a defect code.
A Defect: Defect is not too obvious to consumer (defect not easily noticed by consumer & consumer perception of product quality not affected)
B Defect: Defect may damage brand image (defect is easily noticed by consumer & consumer perception of product quality is slightly affected)
C Defect: Defect damages brand image (defect is clearly noticed by consumer & consumer perception of product quality is negatively impacted)
D Defect: Defect may seriously damage brand image (defect is the most critical & consumer perception of product quality is seriously impacted); these products are not to be shipped to market
AQL is defined in ISO 2859-1: Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection.
It is the maximum tolerable process average of % defects observed.
An AQL of 0.65 is set for B and C class defects combined, and an AQL of 0.15 is set for C class defects.
A class defects are regarded for process quality improvement.
D class defects are not tolerated at any level.
Examples of D Class defects:
Wrong material
Missing products/components
E-liquid contamination

PRODUCT DEVELOPMENT & LAUNCH

Specifications define all recognizable and measurable factors required to manufacture a product. it covers:
Material specifications
Product specifications
Process specifications
Specifications are defined by specification owner and cannot be modified by the manufacturer without appropriate authorisation.
E-cigarette manufacturer is responsible for maintaining the factory specification system, ensuring product is manufactured according to specification and reporting any deviations to the specification owner and R&D QA.

PRODUCT MAINTENANCE

All production materials must be inspected before entering the production process to ensure that they meet specification.
Batches of materials and components must be isolated on arrival and not removed from quarantine until compliance has been assured.
Inspection must be carried out according to documented procedures and results per batch retained.
Responsibility for inspection is split according to material:
1. E-liquids are released by R&D QA and do not require detailed quality inspection by the e-cigarette manufacturer.
2. All other components are inspected and released by the e-cigarette manufacturer.
General process
E-liquid compounder produces a batch of E-liquid dedicated for QC Group products and sends representative samples to R&D for batch release testing.
R&D QA releases a batch of e-liquid for QC Group product and E-Liquid compounder ships it after receiving the QA release to the E-Cigarette manufacturer.
E-cigarette manufacturer receives the batch, checks for any visual defects or undesirable odors.
If any deviations are noted, the batch should be quarantined and R&D QA contacted with full details for further action.
Shelf life: maximum age of the component or finished good in which it can still be considered suitable for use in production or shipping to market
General rule: materials/finished goods should be used in production or shipped to market as soon as possible after receipt or manufacture. Items exceeding shelf life should not be used in production or shipped to market.
Date of production/receipt should be recorded for material batches and inventory control exercised to ensure first-in/first out (FIFO); the oldest material batches should be used first
Maximum shelf life of components should be as indicated by the supplier. Shelf life of finished goods should be no more than 12 months
Shelf life of sealed e-liquid containers is 12 months from date of manufacture. Once containers are opened, the contents must be used within 30 days.
Adverse storage conditions (heat, light, humidity, mechanical stress) are a prime driver for deterioration of quality
E-liquid must be stored below 25ºC. Opened containers must be resealed as soon as practically possible after opening, and it is not permitted to return decanted e-liquid back into a master container.
Nicotine-free e-liquid must be stored separately from nicotine-containing e-liquid.
All other materials must be stored according to suppliers’ recommendations
Finished product must be stored at 20±5ºC and 60 ± 15% relative humidity

PRODUCT MONITORING

Objective
To ensure that finished goods meet Product Quality Standards
Process
Following production of finished goods samples are taken for inspection
The number of samples required is defined in ISO 2859-1, and is related to batch size and level of sampling (normal, reduced, tightened)
Acceptability/unacceptability of the batch is determined by the number of defects observed during inspection
E-cigarette manufacturer is responsible for physical, electrical, functional and visual testing
Sampling is initiated as normal inspection for the first inspected lot.
Switching to reduced or tightened inspection should be carried out once the criteria given in Section 9 of ISO 2859-1 are met.ISO2859-1
Reduced inspection can be introduced after multiple inspected lots which would have been accepted at a lower AQL.Reduced
Tightened inspection must be introduced if 2/5 consecutive lots are deemed unacceptable on first inspection.
E-Cigarette manufacturer is requested to provide representative samples of each product manufactured during a production month to R&D QA.
R&D QA will clearly indicate the required products, quantities and shipping address to the E-Cigarette manufacturer.
E-cigarette manufacturer will arrange shipping by the most expeditious means (normally air freight) with all required shipping documentation.
R&D QA will be informed of dispatch and shipment tracking information by E-cigarette manufacture.

PROCESS CONTROL

Objective
To prepare the manufacturing process for a new production in a controlled manner
Benefits
Eliminate potential for wrong material usage, incorrect assembly or product contamination
Process
Remove all materials from previous production from shop floor
Clean machinery as necessary
Check materials for new production according to specification
Prepare work instructions for new production
Setup machinery and production line
Process (continued)
Calibrate measurement equipment
Start production line, perform start-up inspection
Commence full production when required specifications within tolerances are observed
The Manufacturing Quality Plan (MQP) is a detailed document covering the measurement plans and process control guidelines necessary to deliver product conforming to standards
The MQP should be designed and implemented by the E-cigarette manufacturer
IPC-A-610D (level 2) must be incorporated into the MQP and followed during the manufacturing process
MQP must be shared and aligned with R&D QA, and any subsequent changes shared in advance.MQP
Full records of inspections made according to the MQP must be made and retained for 5 years.
QUIP covers the process of Quality Unsure finished product inspection. It is activated when product not conforming to specifications or failing to meet quality criteria is observed.
Benefits
Ensures defective product is not shipped
Clear guideline for effective and efficient decision making
E-cigarette manufacturer is responsible for following guidelines and setting and maintaining factory non-conforming/blocking procedures
Action taken is related to defect level
D Class defects require stopping the production line, taking immediate corrective action and carrying out 100% inspection to the last good check.
For B or C class defects, product should be resampled and rechecked to confirm the issue
B Class: Management verify if defect is consumer-noticeable. If yes, shut down production line, fix problem and sample/inspect case by case back to the last good check.
C class: Shut down production line, fix problem and sample/inspect case by case back to the last good check.
The QUIP event should be recorded and details sent to R&D and QA

QUALITY MANAGEMENT

Correct hygiene management is essential to mitigate the risk of foreign matter contamination
E-cigarette manufacturer should:
Ensure state-of-the-art sanitation management
Implement and maintain a foreign matter control program
Maintain documented procedures and inspection records
Examples:
Uniform (cap, coat, gloves, mask)
Standardised cleaning and inspection
Standardised building maintenance
Clearly organised workstations with no unnecessary materials
Standard process for dealing with communication expressing dissatisfaction with product quality, and collect, categorise and evaluate complaints from consumers
1. Divided into Routine and Special complaints
2. Routine: product performance, normal visual quality defects
3. Special: Health/legal related complaints
Details of manufacturing-related complaints are communicated to e-cigarette manufacturer for further action
E-cigarette manufacturer is responsible for:
Corrective/preventative action for complaints related to manufacturing process
Timely reports and feedback to R&D
Continuous improvement of manufacturing quality
Reimbursement or replacement of defected devices
Serious Quality Incidents cover:
Health and safety related risks (actual or potential consumer injury)
Corporate risks (product not registered for sale, confidential product shipped)
Contamination/Foreign Matter
Serious Manufacturing Defects
In case of Serious Quality Incident in market, R&D QA will inform e-cigarette manufacturer for immediate investigation and action
E-cigarette manufacturer is responsible for:
Corrective/preventative action as highest priority
Report and feedback to R&D QA as soon as it is practically possible
Reimbursement or replacement of defected devices to customers
In case E-cigarette manufacturer’s internal investigations indicate the possibility for a Serious Quality Incident, they should proactively inform R&D QA with details and the range of products which may be affected
E-cigarette manufacturer must ensure full traceability of finished product and materials used in their production
Benefits:
Supports root cause analysis in case of defects/complaints
Enhanced shelf life control
Supports product recall process
Material traceability
Manufacturer must take records to track the flow of each material batch from delivery and IMI to finished product batch.
Finished product traceability
Manufacturer must utilise a product date coding schematic which allows traceability back to :
Date of manufacture
Production date
Details of the product date coding schematic must be shared
Outline of minimum required level of traceability

Worker competency must be assured to mitigate the risk of quality fluctuations from untrained personnel
E-cigarette manufacturer must:
Identify required competencies for each position
Ensure a training program is in place and followed
Maintain detailed training records for each employee
Regularly review training plan based on actual operational status
Manage staffing plan according to training evaluation/experience of personnel
Competencies required for each process must be defined, and workers must not be engaged in actual production until training has been delivered and its effectiveness assured.