Toy Testing: How To Comply With En 71 & ASTM F963

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Toy Testing: How To Comply With En 71 & ASTM F963

With the strict safety and quality standards of children’s toys, there is absolutely no room for non-compliance. Compliance issues can cause potential health hazards and in some cases fatalities. Here we discuss the importance of toy testing and provide you with an exact outline of toy safety regulations and all of the most recent updates to help you avoid compliance issues, so that you can continue to produce toys of the highest quality. The toy industry is a lucrative one with “toy sales in 2015 increasing by 4% over 2014 to $87.4billion…with estimated growth expected to exceed $90 billion in sales in 2016.”

There is surely continued opportunities for economic growth and sustainable innovation in this massive industry going into 2017 and beyond.

But, the toy market, and product safety specifically, makes it a volatile one.

What happens when due diligence is left by the wayside?

41% of toys that were recalled in the EU alone were due to choking hazards, whilst chemical compositions makes the second largest recall between January 2016 and July 2017.

By looking at the graph below, you will see the breakdown of recalls over this period of time:

Toy testing regulations and compliance issues

The stats above paint a clear picture for importers to abide by toy safety compliance standards, for it is not only in your best economic interest, but also for your brand’s protection and growth.

Today, children’s toys are subject to some of the strictest safety and quality standards in the retail marketplace due to the sensitive nature of their consumer base.

The question is…

How do importers keep up with the latest news in toy safety regulations to avoid potential disasters and recalls as reflected above?

In this blog post, I seek to highlight the EU EN71 safety standards that your imported toys need to comply with. I will also highlight the latest updates of this standard, to ensure you are up to date with the latest in toy compliance.

We also look at the US standard, ASTM F963, where we will highlight the latest updates to ensure that your products are in compliance. Lastly, I seek to provide you with actionable steps to achieving compliance according to these standards and what you can do to continue producing children’s toys of the highest quality.

EN 71

The EN71 is a set of European Product Safety standards that apply to all toys, sold in the European Union. The EN 71 also forms a part of the CE directive. As an importer of children’s toys you will need to ensure that the toys you are importing into Europe are labelled with this CE mark.

This mark basically stipulates that a particular toy is compliant with the safety regulations as laid out by the European Union and its safety standard.

Here is a table of what this standard is inclusive of, but I will also highlight the ones that have been updated recently so that you, know exactly what your products need to be compliant with;

TABLE of EN71

Toy testing & safety regulations - En 71

The latest EN71 update includes

The latest children’s toy update and revision of the above table is as follows;
The CEN has published Toy safety standard EN 71-12:2016 for n-nitrosamines and n-nitrosatable substances. This standard is expected to be harmonized under Toy Safety Directive 2009/48/EC by publication in the Official Journal of the European Union (OJEU).
Major change of the new version includes this;

  • More stringent limits of n-nitrosamines and n-nitrosatable substances for toys intended for use by children under 36 months and intended or likely to be placed into the mouth of the child.
  • a modified definition for ‘elastomer’ from ISO 472:2013 (Plastics – Vocabulary, for better clarity)
  • a new procedure for the extraction process for toys and parts of toys other than balloons
  • use of porous graphitic carbon (PGC) reversed phase (C18) high performance liquid chromatography (HLPC) columns as an additional option for analysis
  • an additional set of multiple reaction monitoring-transitions (MRM-transitions) for quantification and identification

What this revision should mean for your sourcing and production strategies

This standard is applicable to the following products;

  • Toys and parts of toys made from elastomers and intended for use by children under 36 months
  • Toys and parts of toys made from elastomers and intended to be placed in the mouth
  • Finger paints for children under 36 months

Manufacturers will need to provide evidence of compliance from the supplier of these materials, before the manufacturing of these items can proceed. There may also be a random sampling after mass production for post production testing to ensure you are not in violation of the above safety regulations.

ASTM F963-16

The ASTM F 963-16, The Standard Consumer Safety Specification for Toy Safety, is a comprehensive standard that addresses numerous hazards that have been identified with toys.

Toy testing & safety regulations ASTM F963-16

 

The latest ASTM F963 update includes

  • Among the changes, the 2016 revision addresses ride-on toys with: a new curb impact requirement, a clarification of overload and stability requirements, and a strap exemption.
  • new labelling requirements for toys that have certain small coins or button batteries,
  • temperature and current-limiting requirements for lithium-ion batteries, and
  • new requirements for materials and toys that could expand if accidentally swallowed.
  • Other revisions include:

– new soaking and compression tests for magnets

– new requirements and clarifications related to microbiological safety;

– clarifications to heavy elements requirements for toy substrate materials

– revised requirements for toys involving projectiles; and,

– clarification of requirements and supplemental guidance for impact hazards.

What this revision should mean for your sourcing and production strategies

You will have noticed that all children’s toys that have been produced after 30 April 2017 needed to be tested according to ASTM F963-16.

According to ASTM F963-16 all toys that are intended for children of 12 years old and under need to be tested by a registered CPC third party testing and quality provider, who will then furnish you with the appropriate product specific CPC which declares that your product complies with the federal toy safety standard.

Suggestions for complying with these toy testing regulations

As an importer you may be feeling overwhelmed about adhering to the regulations as laid out above and while you should be doing everything you can to adhere to them, here we lay out a few suggestions of how to go about doing this;

  • You need to work towards improving quality control procedures by strictly monitoring the quality of raw materials. Do not fall into the trap of using cheaper, substandard materials. Whilst this may be appealing for cost reduction, you will be putting your brand at unnecessary risks.
  • Improving your products quality always needs to be a primary goal. Many of the new updates in regulation also stipulate the use of a third party quality provider as mandatory for your products compliance.
  • Ensure you use a third party company that is up to date with the latest in toy testing and safety regulations. This will reduce the risks of potential product recalls resulting in a bad image for your brand, but also a loss in revenue.
  • Seek new non-toxic environmentally-friendly raw materials. How do you go about sourcing your raw materials? This may step may be a little more difficult to pursue, but let’s take a look at Lego. Their blocks are made of plastic, but currently, they are investing loads of money and time into finding alternatives to plastic for their famous building blocks. It’s this kind of commitment that ensures a positive and innovative position in the market place.

Understanding the regulations and what they mean for your current sourcing strategy for children’s toys will help give appropriate direction and guidelines to your current competitive positioning in the market place.

By understanding these regulations and ensuring compliance according to them, you are able to guard yourself against potential product recalls and even potential lawsuits that could come from health and safety violations that are sadly too often found within children’s toys.

“API is equipped to meet the above product testing and safety requirements accordingly to ensure your brand’s safety and protection.”

 

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DUPRO & Toy Testing: The Key To Improved Toy Quality

An average of more than 100 children’s toys are recalled every year due to critical defects. Recalls and quality issues can be prevented with DUPRO quality inspection and subsequent toy testing. Learn about what to expect during a DUPRO inspection and why it is the key to improved toy quality here.

Why A DUPRO Inspection for your children’s toy factory?

DUPRO inspection and toy testing More often than not performing an inspection after the production of toys is finished is problematic and too late to rectify any quality problems found within the product. Enter During Production Inspection (DUPRO). This inspection type is designed to catch quality issues right on the production line to prevent any delays in getting your product to market.

What Can You Expect Of A DUPRO Inspection?

A DUPRO inspection is one of the most commonly used quality inspection types and is normally carried out after mass production has begun when approximately 40% of your toys have been produced and 20% of them have already been packaged. A quality control inspector will normally go through the inspection line of your toy factory to identify any quality problems that may arise during the production processes. An inspector will have a checklist to assess the production, which is inclusive of the following;
  • Is the production of the toys conforming to the product specs as laid out by the importer/retailer?
  • Based on the sampling plan that was decided upon a quality control inspector will look at the children’s toys for any visual defects that may be present and analyze them against the acceptable quality limits as set by the importer/retailer.
  • An inspector will conduct on-site toy testing. This is dependent on the product of course, but many children’s toys will have a drop test performed to analyze a real-life simulation of the toy. The fidget spinner is a good example of the type of toy that would undergo an onsite drop test to ensure the inner bearings do not pop out. If they do not this item would be deemed safe and fit for use according to ASTM F963. Toy testing a fidget spinner
If the above criteria are not met, the supplier will then need to consider corrective action plans and possibly a Root-Cause Analysis (RCA) to work out the problem and devise improvement strategies based on the findings. This inspector will then produce a full detailed report with images of non-conforming toys and any notes that are deemed necessary and important, allowing you the insight into the quality of the work being done to complete your order. So, what do you do with a DUPRO report? Once your supplier receives the inspector’s findings within the report, your supplier will need to adjust the production process to ensure that the issues found are rectified. **NOTE – If you have to delay production to wait for your supplier to rectify what was found in the report, do so. Why? Product recalls! You do not want to subject your brand to potential recalls that could result in costly law suits causing embarrassment to you and your brand.

Key Takeaways

A DUPRO primarily will;
  • Highlight your supplier’s conformity to product specifications
**TIP – It will be crucial for you to adequately and clearly define these for your supplier.
  • Analyze the acceptable quality limits as set by you
  • As a part of the DUPRO inspection, your QC inspector will perform basic on-site tests to evaluate the children’s toy quality and conformity.
Conducting a DUPRO quality inspection in itself is not recommended as industry best practice, as it does not showcase the average quality of toy that a supplier can produce. So, what is recommended then? It is recommended to couple your DUPRO inspection with a Final Random Inspection to ensure that your children’s toys conform to acceptable levels of quality as laid out by you the importer or retailer.

TAKE A DIVE INTO OUR QUALITY INSPECTION GUIDE THAT WILL HELP WITH IMPROVED PRODUCT QUALITY

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Evaluating third-party toy testing partners?

Toy safety is the number one priority for parents around the world. Taking measures to conduct toy testing and maintaining compliance across various international toy safety standards shows customers in your destination market that safety matters to you too, and ultimately, that your products are suitable for all children to use and can be sold there.

 API are committed to assisting all toy brands and importers with expert quality assurance solutions that address issues from the very outset of toy conception and design, to inline inspection and pre-shipment testing, all the way up to loading checks and warehouse inspection.

Deciding which third-party provider is the most suitable partner to put your products to the test can be a difficult one, but it doesn’t have to be.

We have taken the liberty of drawing up a list of frequently asked questions (FAQ) about our toy testing and quality assurance solutions that will help provide you with peace of mind before you get in touch with us.

“Which quality assurance solutions does API provide for toys?”

API offers coverage throughout all of the stages in your supply chain which include factory audits, laboratory testing and inspection services.

Toy testing services throughout the supply chain cycle

 

“How do I find out what risks and dangers my toys may present?”

Through comprehensive design evaluation and hazard assessments, API can help you identify potentially dangerous design features and mechanical risks from the outset. All of this can help you save on costly redesign and engineering resources related to product modification, and more serious quality and safety issues later down the line.

Furthermore, the evaluation also helps to identify all of the necessary tests that you would need to submit your product to.

“Which directives and standards does API adhere to in their toy testing and certification?”

While EN 71 and EN 62115 apply in the EU, the ISO standards for international testing and standards such as ASTM and CPSIA are valid in the USA. API helps to certify and test your toys in accordance with the requirements of your destination market, ensuring that you remain compliant no matter where your business expands to.

“What is the turn-around time for international toy tests with API?”

The turn-around time for our toy testing procedures are as follows:

  • Standard: 5 days
  • Express: 3 days
  • Emergency: 1 day

What compliance documentation is needed to ensure conformity of toys?”

Whether your brand is directly or indirectly affected by Directive 2009/48/EC, it is of vital importance to ensure the collection and gathering of all the necessary technical documentation needed from your manufacturer to demonstrate the conformity of the product to the applicable requirements of the TSD (Toy Safety Directive).

API’s Technical Compliance File (TCF) solution is a one process procedure that consists of 5 steps to ensure total product compliance:

 

 

 

“What accreditations does API hold in the toy quality space?”

API is a member of AFNOR ( Agence Francaise de Normalisation) and the Toys Standardization Committee in France.

This puts API in a unique position to update your company regarding the latest developments and discussions on toy regulations before new regulations are officially published.

We can provide you with a European Notified Body endorsed report by our French lab Albhades Provence, a member company of the Worms group.

The benefit of this is that when the Notified Body is convinced of a product’s compliance, it issues a certificate of conformity to confirm this. Only a notified body is entitled to do so.

API was also one of the first foreign entities to officially operate inspection services in China.

Our testing laboratories, of which we have 5 in Asia and 1 in Europe, hold the following accreditations:

 

Laboratory toy testing accreditations

 

“How is API uniquely positioned to provide me with the best quality assurance solutions?”

API prides itself on being able to focus on the unique issues each and every one of its clients faces by offering tailored solutions to address them.

Our team of ‘on the ground’ specialists are well-versed in a wide range of complex product categories, helping us to deliver more personalised services that include:

  • Dedicated key account manager

Each client has their own dedicated key account manager to handle their quality assurance needs, keeping an open line of communication with the client at all times for added peace of mind.

  • Direct contact with our laboratory specialists

When urgent decisions need to be made, having real-time information from the experts conducting your testing can help you avoid any costly delays. This is a service not usually provided by other quality assurance providers.

  • Assistance when you need it

Get in touch with your dedicated key account manager any time during Asian business hours on weekdays. Should you require further technical assistance, our experts are standing by to answer your queries within 24hrs, regardless of when you need them.

 

Do you have any other toy testing queries you’d like us to answer?

Feel free to contact us or simply leave a comment below and we’ll get back to you as soon as possible.

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Heavy Metals Testing in Toys: EN 71-3 and ASTM F963-17

Heavy metals testing in toys and safety requirements have become increasingly stringent in recent years, and with due cause: 29% of recalls in 2016/2017 were due to chemical hazards alone. The onus lies on manufacturers and importers to comply with safety standards, ensuring that toys are manufactured according to the latest specifications. In this post we look at the new updates for toy safety regulations, the tests to be performed to meet the new safety specifications, as well as the steps you should take to avoiding heavy metal migration in toys and preventing future quality issues. It’s little wonder then that the new limits for the EN 71-3 standard as set out by the European Union (EU) will become mandatory as of 28 October 2018. Additionally, ASTM International published a direct final rule on 4 December 2017, approving ASTM F963-17 as the obligatory standard. The chemical composition of toys can pose an alarming threat to a child’s health. Toys can contain traces of heavy metals such as antimony, arsenic, bromine, cadmium, chromium, lead and mercury. These heavy metals can cause a range of harmful effects, from respiratory disorders to neurodevelopmental issue, from cancer and even to death. As these effects are untreatable, when it comes to heavy metal migration in toys, prevention is better than cure, which is what the safety specifications seek to ensure.

Why the need for safety regulations arose

Toy quality control plays a role in not only ensuring the health of consumers, but also in brand reputation. However, the use of the toxic metal, lead, in the manufacture of toys has not been banned. Lead is often found in chalk, crayons, modelling clay, paint and varnish plus it is widely used as a stabilising material in the manufacture of PVC.

Cost is one of the common reasons toys are manufactured with materials containing heavy metals. For example, lead-based paints are up to 30% cheaper than paint with lower lead levels. In the highly competitive toy manufacturing market, many factories will attempt to lower overheads and boost profits by using cheaper leaded paint on toys.

A 2015 study, which was performed by Nepal’s Society for Legal and Environmental Analysis and Development Research in conjunction with Ministry of Science Technology and Environment, analysed the heavy metal content of 100 toys. This research showed that 99% of the toy samples contained a higher level of chromium than the limit of multiple countries. Additionally, 26% of the samples contained lead contamination while 13% held traces of cadmium and every sample had more zinc than the limits allowed by ISO or the US. In another case study, published in the Journal of Taibah University for Science in November 2017, 25 toys imported from China to Nigeria were sampled for potentially toxic materials. Ternary acid digestion and Atomic Absorption Spectrophotometry determined the potentially toxic metals in the sample. Alarmingly, the total concentrations of potentially toxic metals in the samples were 36.1-107mg/kg for lead, 3.55-40.7mg/kg for cadmium, 1.83-38.9mg/kg for chromium and 9.78-159mg/kg for copper. In an unregulated market, it’s clear that heavy metal migration could run rife, with potentially disastrous consequences.

Updates to toy safety regulations

Heavy metals testing in toys for leadTo minimise the possibility of heavy metal migration in toy manufacturing, the EU has tightened the regulations of toy quality control. Testing according to the revised EN71-3 standard includes 19 elements and the migration limits have been revised. The update has divided toys into three categories:
  • Category 1: Dry, brittle, powder-like or pliable materials.
  • Category 2: Liquid or sticky materials
  • Category 3: Scraped-off materials

The limits for lead – which were previously set at 13,5mg/kg in dry material, 3,4mg/kg in liquid material and 160mg/kg in scraped off material – have been revised and the new limits are 2.0mg/kg, 0.5mg/kg and 23mg/kg respectively.

It is a requirement of the CPSC that toys manufactured after 30 April 2017 are tested according to the ASTM F963-17 standard, which covers eight heavy metals. Manufacturers and importers of children’s products must certify, in a written Children’s Product Certificate (CPC) based on test results from a CPSC-accepted laboratory, that their children’s products comply with applicable children’s product safety rules.

What tests must be performed to meet the safety specifications?

It’s vital that third-party laboratories are accredited to ensure compliance. Labs must be able to determine their measurement uncertainty and correctly interpret if this result complies with the migration limits of EN 71-3. To accurately measure heavy metal content, raw material chemical testing should be carried out:

  • Raw Material Chemical Testing
Tests are carried out for the full range of common toxic chemicals and elements, including phthalates, lead, mercury, and cadmium.

Pre-testing raw materials before they’re crafted into toys avoids taking goods to market that are unsafe for use, and that can lead to costly redesigns or recalls.

API offers RSL (restricted substances list) screening services and toy testing to assure that your products comply with the latest REACH and EN 71-3 safety requirements.

Under the ASTM F963-17 regulations, laboratories must also test compliance for eight heavy metals including toy substrate metals. These include arsenic, barium, cadmium, chromium, lead, mercury, and selenium. The soluble limits for each (in parts per million) are as follows: arsenic: 60ppm, arsenic 25ppm, barium 1 000ppm, cadmium 75ppm, chromium 60ppm, lead 90ppm, mercury 60ppm, selenium 500ppm.

How to prevent heavy metals from entering your raw materials

Toy raw material quality control

Prevention is better than cure, particularly with toy safety control. Follow these steps to circumvent heavy metals entering your raw materials:
  • Raw material quality control is vital to ensure compliance, as well as chemical testing. Ensure accountability in your supplier chain through regular testing of raw materials. API offers a Restricted Substances List (RSL) screening service. Through this screening service, we can quickly determine whether non-compliant products need to be re-tested. We also advise that our clients undertake a chemical test for the full range of toxic chemicals, including cadmium, lead, mercury and phthalates.
  • You can successfully avoid putting your brand’s reputation at risk by using only high-quality materials, rather than sub-standard, cheaper alternatives.
  • Source environmentally-friendly, non-toxic raw materials rather than those which contain lead and other heavy metals.
  • Use an accredited, reliable third-party quality provider that is up-to-date in toy testing and safety regulations. Our Hong Kong laboratory is accredited by major accreditation bodies globally to perform laboratory testing for the American, Australasian and European markets.
  • With API’s DUPRO/Inline inspection, we can assist you in achieving EN 71-3 compliance. For full assurance of toy quality control, a DUPRO inspection will monitor the production line when at least 25% of the order has been completed. The DUPRO tests whether irregularities from the Initial Production Check have been corrected.
If a test comes back positive, an evaluation of the formula of the material/varnish should be carried out in order to highlight ingredients that may have caused the failure. Such ingredients should be changed or the material/varnish should be replaced with a safe one.

How API can assist with Toy Safety compliance

At API, we offer our clients a host of tailored solutions to enable you to meet your regulatory requirements. We are dedicated to staying abreast of the latest regulations and updates across international markets. From lab testing to certification to inspection, we ensure your factory is compliant with global safety and legal standards. We provide customised factory audits according to your needs and protocols as well as combined audits (technical and social as well as social and environmental.) As one of the first foreign entities to offer accredited inspection services in China across all consumer product categories, our Hong Kong laboratory has EN 71-1, 2 and 3 accreditation, EN 62115 as well as ASTM F963-17 (physical and mechanical, flammability, chemical and electrical.) Contact us today for assistance with EN 71-3 and ASTM F963-17 compliance.
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8 Steps To Limit Risk in Your Toy Testing Procedures

Production competitiveness has become so high in countries like China that suppliers often find ways to cut corners in order to save costs, often putting the quality and safety of your toys, and their extremely vulnerable user base, in jeopardy. When it comes to upholding product safety and compliance, no other consumer goods product is more highly regulated than toys. However, despite stringent requirements and mandatory safety toy testing around the world, unsafe children’s products continue to reach the market today.

As recent as 2017, many importers of the popular ‘fidget spinners’ were found to be selling products in the US that contained alarmingly high levels of mercury and lead leading to mass product recalls and damaged brand reputations.

Non-compliance in the toy industry present a myriad of dangers for brands that can lead to heavy financial losses, unnecessary recalls, and a damaged reputation. It’s reasons like these that quality managers constantly live in fear of quality issues with toys, but it doesn’t have to be this way with strict compliance regulations and proper toy testing procedures.

Improving Your Existing Toy Quality Assurance Processes

Toy quality assurance and toy testing As a quality manager who is responsible for producing toys you know that where quality is concerned the stakes are sky-high. You need to know that toys adhere to the demands of every test they might face when being exported globally to markets with different demands. At API, our quality inspectors and laboratories follow a comprehensive set of 8 toy quality testing steps (built through decades of experience) that helps quality managers effectively manage quality right from the outset. This article will take a brief look at the global toy testing standards themselves, and the step by step procedures API follows to help minimise the risk of quality issues sneaking through and danger of recalls happening, as well as protecting your supply chain and ensuring customer safety and satisfaction.

API’s 8 Step Toy Quality Assurance Process

Click here to watch our comprehensive toy testing process video

1. Preventing Mechanical Risks In The Design Stage

Product Design Specification (PDS) serves as the guideline for understanding the various problems identified early on in the design stage. Possibilities need to be investigated and filtered through various criteria laid out in the PDS to be set forth as practical, viable solutions that require further evaluation.

Through comprehensive design evaluation and hazard assessments, API help you identify potentially dangerous design features and mechanical risks from the outset, helping you save on costly redesign and engineering resources related to product modification, and more serious quality and safety issues later down the line. Furthermore, the evaluation also helps to identify all of the necessary tests that you would need to submit your product to.

2. Preventing Toxic Risks With Raw Materials Testing

Raw material toy testing to ensure toy quality Raw material quality control is paramount in helping to prevent product failure and ensuring a consistent level of quality that you and your customers expect. Making sure that players in your supply chain are continuously subjected to testing of raw materials being used in your toy production, or when they decide to switch suppliers, verifies that the materials are at the level of quality you’re paying for and that no toxic elements such as lead and cadmium finding their way into your finished product. Complying with chemical restrictions in raw materials laid out by the EU and US chemical content regulations such as REACH, EN71 and CPSIA starts with chemical testing. API’s laboratories help to identify toxic elements that can aid you in defining a list of approved materials to be used in the toy production process early on, ensuring your products comply with the limits set for safe use now and into the future.

3. Evaluating Toy Safety Before Mass-Production Through Prototype Testing

The practical solutions and tests identified in the design evaluation stage are embodied in the form of a prototype. The aesthetics, functionality, mechanical aspects, as well as the potential manufacturing issues are all considered, and these aspects need to be thoroughly tested. API’s technical experts are part of technical committees that discuss and write standards for toys, and can ensure you are up to date on the latest developments and discussions on regulation before new regulations are officially published. API’s Hong Kong Laboratory is accredited by HOKLAS to perform laboratory testing for the European, American and Australasian markets. The three main areas of testing are:

1) ‘Mechanical and Physical Properties’

  • Drop Test
  • Compression Test
  • Torque Test
  • Tension Test
  • Flexure Test
  • Bite Test

2) ‘Flammability’

  • Conducted on  toys to examine their flammability characteristics

3) ‘Restricted Substances – Chemical Testing’

  • Lead content test
  • Cadmium content test
  • Phthalate content test
  • Other applicable chemical tests

Prototype testing helps to identify the shortcomings of initial toy design and how they will hold up in real use case scenarios.

Toy testing at a factory

Evaluate your Factory

Perform a quality management audit with specific points related to toys, such as ensuring that sharp tool equipment and a broken needle policy has been used and properly calibrated. It is also important to ensure that your factory has also established traceability system for identification and tracking materials through production. Through this testing process, API helps you to further refine the product design and remove any obstacles that may detract from the original concept by making it safer for use, and ultimately, preventing the need for costly recalls well before the products hit the production line. On top of this testing process, API are also entitled to issue certificates of conformity as a ‘Notified Body’.

4. Ensuring Compliance Through All Inclusive Compliance Software

Whether your brand is directly or indirectly affected by Directive 2009/48/EC, it is of vital importance to ensure the collection and gathering of all the necessary technical documentation needed from your manufacturer to demonstrate the conformity of the product to the applicable requirements of the TSD.

It is up to your product manufacturer to draw up this technical documentation, or request it from relevant parties, and keep it and the EC declaration of conformity for a period of 10 years after the toy has been placed on the market. It is up to you as the importer to ensure that the manufacturer fulfills this duty, that the toy bears the required conformity marking, and is accompanied by the required technical documents. These documents must be made available to national surveillance authorities upon request for the same period of time to demonstrate conformity of the toy. Technical documentation to be drawn up and collected must be presented in one of the official languages in the EU and shall include: 1. Description of the design and manufacture 2. List of components and materials 3. Safety data sheets 4. Safety assessments 5. Conformity assessment procedure 6. EC declaration of conformity 7. Addresses of manufacture and storage 8. Documents submitted to a Notified Body 9. Test reports 10. Conformity of series production details 11. EC-type examination details 12. Conformity of series production details Today, many manufacturers, importers and retailers are still operating on outdated systems like collecting multiple spreadsheets and files, leading to unreliable data and outdated documentation, which creates an almost insurmountable task of trying to accurately trace and maintain the information for each product reference. API’s Technical Compliance File (TCF) solution is a one process procedure that consists of 5 steps to ensure total product compliance: 1. Expert intervention to define the scope of compliance 2. Document collection 3. Document review 4. TCF report issuance 5. Record keeping and database integration (all available online 24/7)
A solution like this promises increased visibility and transparency into your supply chain that will prove invaluable to optimizing your current quality systems, allowing you the time to mitigate any potential quality risks as and when they become apparent.

5. Monitoring Production Consistency With DUPRO/Inline Inspection

The production line is inspected when at least 25% of the order has been completed. The DUPRO verifies that initial discrepancies found out during an Initial Production Check (IPC) have been rectified.

Each stage of the assembly process will be analysed and samples of the goods in progress will be collected and checked. This means that any impending problem can be identified on-site and addressed at the very stage where it is occurring. By checking unfinished products during production and assessing if AQL standards are being met, API assures that corrective actions can be taken in order to assure the quality of your toys moving forward.

6. Checking and Classifying Non-Conformities Right Before Shipping

API conduct both Final Random Inspections and Loading Check inspections to ensure your products conform and that they are being shipped in a safe and secure manner.

Final Random Inspection

A FRI (Final Random Inspection) is basically an acceptance sampling inspection performed prior to shipment. The Sampling is derived from the inspection level requested in accordance with MIL-STD-105E (ISO2859-1). API is also certified HKIAS which endorses third-party inspection based on an in-house procedure. The sampled goods are then checked piece by piece and the non-conformities found, if any, will be classified into three categories (critical, major and minor). The selection of an AQL (Acceptable Quality Level) per type of non-conformities will determine the acceptance or rejection of the goods.

Sample Collection For Lab Testing

Products randomly picked from mass production for pre-shipment testing which can occur in DuPro or FRI. The test checks the alignment of product quality from mass production and pre-production.

Pre-shipment Testing

The aim of pre-shipment testing is to verify the consistency of the production quality with a focus on critical aspects of the toys, without having to perform the full test again. API provides tailor-made testing solutions based on client requirements to ensure quality is maintained at this stage of the process. Loading check inspections to ensure toy quality

Loading Check Inspections

The loading check serves as a way to control container quantity and to adequately manage stuffing arrangement. API performs inspections of packed goods as they are being loaded into the shipping container to ensure the correct products are loaded, in a secure and safe manner.

7. Taking Quality Assurance Full Cycle With Reorders and Random Sampling

Sample collection for testing during the reorder process is a concept of a highly effective continuous quality improvement monitoring program, helping you determine the frequency of testing per supplier performance. This policy sends a clear message to suppliers that you’re watching their product quality closely, and that any unauthorized product/material change is strictly prohibited, and at the same time encourages them to improve.

8. Business Intelligence Tools

In order to the determine the frequency of sampling per factory, you’ll need a comprehensive vendor scorecard. API have developed its own platform for you that records quality data of each factory’s test and defect levels during inspection.

It also provides you with a comprehensive data analysis on factory performance across your own suppliers and across others in our database that you may not currently be working with. The database record does not simply include just the pass or failure of the product test/ inspection, but also a record and classification of each defect. Through this database we’re able to point out top defects recorded per factory and compare your own suppliers against others in the industry.