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Introduction Retailer Requirements Concept of Due Diligence Metal Detection Risk Mitigation Through Good Working Practices Needle Control Programme Needle Detection Keeping Records Needle Audit Summary Literature References
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1 Introduction
A series of incidents in the early 1990's including children receiving scratches from broken needles in clothing, a sportsman hurting his foot on a staple buried in a trainer and others alerted many retailers to the hidden dangers of metal contamination. Hence, it has become the responsibility of the manufacturers, of textiles, apparel, soft toys and in fact, of any item of sewn product likely to be in next-to-skin contact, to take every precaution to ensure that their products are safe, free from contamination and not likely to harm the end user in any way. In these litigious times, it is in the best interests of all manufacturers to take steps to ensure they have systems and procedures in place to minimise the risks and, in the event of a claim, have the necessary procedures in place and documentation available, to prove they have been diligent in their manufacturing process to the best of their ability.
Are you confident that your systems and procedures will stand up to scrutiny?
If present, metal contamination can have serious consequences for: Consumers:- injury from a needle fragment, in worst case may lead to transmission of blood borne viral infection Retailers:- potential legal claims from affected consumers; product recall to ensure that other customers are not similarly harmed; cumulative costs of recall, litigation and reparations; loss of brand reputation Manufacturers:- retailers may impose mandatory fines and could terminate the supply contract. This could lead to factory closure if the business is largely reliant upon that single retailer.
2 Retailer Requirements
As stated above, potentially serious consequences may result if a broken needle tip is left behind in a garment. Hence, to protect their own position, retailers make it mandatory that their suppliers take a range of steps to ensure their products are free of metal contaminants. The concept of "Due Diligence" is frequently an integral part of these requirements.
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The Due Diligence defence is available to manufacturers accused of a breach of regulations. Essentially, the defence is that the "accused" took all reasonable practicable steps to avoid the breach. Therefore, those charged need to prove that: all reasonable precautions were taken; they exercised all due diligence to avoid the occurrence, whether personally or by any person under their control. "Taking all reasonable precautions" includes setting up systems and controls which are appropriate to the risk. What is reasonable is determined by the size and resources of the business. "Exercising all due diligence" involves having procedures in place which review and audit the system to ensure it is operating effectively in order to avoid placing contaminated product on the market. Whether or not a defence will be successful depends on the circumstances surrounding each case. Doing nothing is not an option! This legal concept informs the QA policy of the Retailers who may require their suppliers to put in place measures to ensure, if a claim were to arise, that documentary evidence exists to show that due diligence has been applied. In apparel manufacture, use of a Metal Detector within a comprehensive Product Safety policy would usually form part of a 'Due Diligence' defence.
2.2.1
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A natural consequence of ferrous-only metal detection is that the rest of the product, inclusive of fabric and any point-of-sale packaging included, must be free of any ferrous content in order to be fully compatible with needle detection. A product can have a magnetic profile, or a 'Product Effect', inadvertently acquired through the manufacturing process and may be due, but not limited to: moisture content ferrous-based dye stuff fabric treatment mineral residue from stone wash or fabric abrading process recycled packaging
This unpredictable 'product effect signal' can add or subtract randomly from the target contaminant and compromise needle detector sensitivity performance. It is therefore always recommended, that before implementing metal detection, samples of complete product be tested in a metal or needle detector to confirm compatibility.
2.2.2
2.2.3
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A typical set of records, required to be completed and kept by the manufacturer, might include: Metal Detector Calibration Record, showing that regular testing has been undertaken Metal Detected Product Log, per day/ per shift/ per batch Hand Sewing Needle Control Record Broken Needle Record Record of Metal Contaminants Detected
In their most basic form, records may be hand written, but they are prone to human error, their veracity may be questioned, and can take up a lot of management time. Electronic data capture, available with modern metal detection systems, can help increase accuracy and therefore credibility as well as saving management time. In the most advanced machines it is possible to store production and diligence data in encrypted form. As these data can be stored within the machine over longer periods of time it enables the Retailers to verify independently that each of their orders has passed through a metal detector before being shipped.
2.2.4
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3.1.1
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Spare needles:
No machinist must be allowed to hold spare needles All spare needles must be securely stored under supervision Only authorised staff may issue a new needle New needles must only be exchanged either with a worn, or with all parts of a broken needle
Record Keeping:
In addition to having a documented Broken Needle Policy, the following data must be captured throughout the production process: Needle Incident Log: Records all instances whenever a needle breakage occurs by time, date line, style and customer batch order Broken Needle Record: Attempts to recover the needle; as above but with broken needle fragments found and pieced together with tape, to recreate the whole Metal Detection Log: Records all quantities of sewn product processed through each metal detector, by line number, style and customer order etc. Metal Detection Calibration Log: Periodic checks must be performed every day on the metal detector, and results recorded to confirm machine was working before, during and after each batch of product was passed through it. Metal Detector Maintenance Records Personnel Training Record: List of responsible people who have received training in needle control procedures and needle detection Records should be retained for a minimum period which must be the longer of the following two: o as agreed with the buyer-retailer o commensurate with legal requirements relevant to defending a product liability claim arising in the territory where the product is sold
3.1.2
3.1.3
Jewellery
With the exception of wedding bands perhaps, wearing of items of jewellery must be controlled in all production areas and where product is handled in the finishing sections.
3.1.4
Hand Sewing
Additional rules apply to hand sewing because of the additional risks involved: Hand sewing should only be used where an automated solution is not feasible, and in children's garments should be used by exception only The retailer must be made aware of the extent of intended hand sewing operation as early as possible during product development and their agreement sought Replacement of broken or worn needles must follow the 'one in and one out' needle distribution method as per the existing Broken Needle Control procedures Only a limited number of workers be authorised for hand sewing in a designated quarantined hand sewing area
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Hand sewing needles must remain in this controlled area at all times, and nowhere else in the factory All hand sewing needles must be held by the line supervisor, issued at the beginning of each shift and then collected at the end Written records must be maintained for all product processed in this way, by style and customer order and incidents of any broken needle recorded as per the Needle Incident Log All product must be metal detected once all manufacturing an finishing operations have completed
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Metal and 'foreign body' detection technology based on x-rays has existed in the food, pharmaceutical and other process industries for some time. Real time x-ray image processing software can be 'trained' to identify all types of contaminants including broken needles within a sewn product. Whilst cost remains the main barrier to its widespread use, in cases where conventional needle detectors cannot work, for example where there is large inherent ferrous-like 'product effect' that can't be eliminated by process improvement. X-ray may remain the only option available.
3.2.2
3.2.3
Operation Supervision
It is essential that a nominated individual be made responsible, e.g. the Production/Shift or Quality Control Manager. The duties should include: Retaining the key that enables the detector to be re-set following a contamination alarm. This is to ensure correct procedures have been followed to deal with the rejected item and to avoid unauthorised re-starting of the machine. Undertaking regular calibration checks on the detector Ensuring all personnel involved in working with the detector receive proper training in its function and use as well as needle control procedures Maintaining and storing all documentation relating to the calibration, maintenance and operation of the detector and making them available for inspection and audit
3.2.4
Equipment Positioning
An ideal place to locate a metal detector would be just past the end of all sewing and finishing stages. The metal detector should become the final operation itself as the products passes through it into a secure packing area, as shown in the diagram below.
Production Area
Quarantine Area
Needle Detector
In this 'airport style' security measure the metal detector aperture creates the only route for the product to pass through the wall from one zone to the other.
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3.2.5
As an 'end-of-line' operation, each individual item should be presented to the metal detector either in the final packaging as floor-ready merchandise, or at least in a polythene bag wrapping. This is to eliminate the risk of re-contamination if the items were scanned loose and unwrapped. Any time the detector rejects an item the conveyor stops and an alarm is sounded. The item which is just out of the detector aperture on the out-feed side is deemed to be the one to have caused the alarm and therefore contaminated. However it is good practice to sweep all items on the conveyor at that time into the reject bin, before re-starting the scanning process. This way items in the reject bin can be dealt with more efficiently as a separate process once all the production batch has been scanned for shipment. Diagram Fig-1 assumes that the metal detector has a 'stop-and-alarm' type reject mechanism, which is typically fitted to 2nd and 3rd generation machines, hence the positioning of the reject bin to the right hand side of the wall in the area labelled 'Quarantine'. In case of a 'belt return' mechanism, typically found in the 1st generation technology, the reject bin would have to be placed to the left hand side of the wall within the Metal Detection area. Other product inspection schemes: Depending on the code of practice implemented by a retail buyer, different needle detection layouts may be required. These may involve using twin-headed detectors, or two individual machines placed at right angles to each other where the garment after passing through the first one is flipped over and then passed through the second. This scheme mitigates for the inherent weakness of the one-sided coil geometry to ensure any needle fragment if missed by the first is picked up by the second unit. Clearly, any scheme requiring more than one machine will be costlier and will require more physical space. Given that the detection sensitivity of a balanced-coil machine is defined with much greater precision and no such weak areas, only the simplest layout as indicated in Fig-1 is necessary to meet the same level of duediligence. Through-put rates: Choice of the reject mechanism can significantly affect the rate at which items can be scanned through a needle detector. In order to avoid product spillage off the conveyor when the belt return operates causing mix-ups, each item must traverse the full length of the conveyor before the next item can be placed. This limitation does not apply to the simpler stop-and-alarm system. For a comparable product size, conveyor length and speed, hourly through-put up to 5 times greater can be achieved.
Equipment Testing
Once the detector has been installed by the supplier, it becomes the user's responsibility to confirm that the metal detector continues to function to the required specification. These calibration checks should be undertaken each day when the machine is switched on: before the start of product scanning - at the beginning of every new batch at least once during the batch - or more at regular intervals at the end of the batch - just before switching off It is only by testing regularly, can one be confident that the metal detector had maintained its detection sensitivity, and had not developed any faults throughout the production period. Given that different types of metal detectors exist with variants thereof, a '9-point' calibration test method has been devised to have a consistent scheme available by which performance of any type can be checked. Whilst it is essential for the 1st generation, only 1-point checking - through the middle (or 3 middle points if desired) - is needed for machines belonging to 3nd or 2rd generation.
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3.2.6
Operating a 'Quarantine'
All items of product, which have passed through the metal detector should be collected and held back in a 'Quarantine' area until the next calibration check has been made. This is to make sure that the machine had not developed any faults during this period and had maintained it's normal function. Only upon the following test being successful, should the product be released for despatch. If a detector fails a calibration check, then all products collecting in the quarantine area since the last successful check should be returned to the metal detection area. The metal detector should be serviced to fix the fault and the product rescanned. This ensures 'Positive Release' of stock from metal detection to a quarantined dispatch area in accordance with quality management policies common to many retailers worldwide.
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As part of this monitoring process it is recommended that the following questions be asked periodically: 1. 2. 3. 4. 5. 6. 7. The number of needles purchased? The number of needles distributed? The number of worn needles returned? The number of broken needles returned? The number of needle fragments found by detector? The number of missing needle fragments? Number of needle 'incidents' or claims
In an ideal world the figures in 2, 3 and 4 above should sum to be the same as in 1, and the answer to questions 6 and 7 would be zero!
4 Summary
The introduction of a Needle Management Programme will improve the efficiency of a sewn product manufacturing operation through reduction in the risk of contaminants being present in finished products. Typical impact of a Needle Management Programme may be summarised as follows: Before No proper needle control policy: Very few broken needles are picked up early in the process Total reliance on the needle detector at the last stage of the process High volumes of waste product Panic measures and corners cut to avoid shipment delays No means of proving due diligence in the event of a claim High risk strategy! After Needle detector used as an effective tool in the quality process chain: Good needle control and management ensures early removal of most contamination Needle detection is the final safeguard to shipping textile products which are free of metal contamination Ability to demonstrate measures taken to eradicate metal contamination, and mount a diligence defense
5 Literature References
Reduction of Metal Contamination: Building an Effective Programme, 2007. Mettler-Toledo Safeline Limited Tesco Clothing Technical Manual March 2009: Version 1 Quality Management Systems Requirements. International Organisation for Standardisation, Geneva. US Recall News website URL: http://www.usrecallnews.com/ U.S. Consumer Product Safety Commission website URL: http://www.cpsc.gov/
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Disclaimer
No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, for any purpose without the express written permission of METTLER TOLEDO Safeline Limited. This documentation is furnished with restricted rights. The information contained in this manual is provided to assist producers in developing and implementing an effective needle control and detection programme. METTLER TOLEDO Safeline Limited does not warrant the accuracy or applicability of the information contained herein and as such is specifically not responsible for property damage and/or personal injury, direct or indirect for damages and/or failures which may be caused as a result of the information provided.
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For more information Mettler-Toledo Safeline Limited. Montford Street, Salford, M50 2XD, UK. Tel: +44(0) 161 848 8636 Fax: +44(0) 161 848 8595 E-mail: safeline.info@mt.com
Subject to technical changes 03/11 Mettler-Toledo Safeline Limited Printed in the UK SLMD-UK-WP-EN-YDS-QC-0311 (M)