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For more information visit www.brcglobalstandards.com

Page 1 of 153 Interpretation Guidelines CP Draft 1

GLOBAL STANDARD FOR CONSUMER PRODUCTSINTERPRETATION GUIDELINE

2010British Retail ConsortiumLondon: TSO

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Contents

Section I Overview1 Introduction

1.1 Why is the guideline needed?

1.2 Status of the guideline2 General and Background Information

2.1 Summary of the Global Standard2.2 What is certification?

2.3 The benefits of certification

2.4 The cost of certification2.5 The value of certification2.6 Time to achieve certification

2.7 Will it be too difficult?

2.8 Scoring and continuous improvement

2.9 The history and background of the Global Standard

Section II Product Groups and Risk Assessment1 Defining Product Scopes

2 Assigning the Correct Product Group2.1 The difference between manufacturers and packers

3 Using the Decision Trees

3.1 Product Group 1

3.2 Product Group 23.3 Product Group 3

4 Process of Risk Assessment the Basics

5 Product and Process Risk Assessment

5.1 Risk assessment of the product design and materials5.2 Risk assessment of the manufacturing process

6 Planning a Risk Assessment

6.1 Setting up a team

6.2 Team activities

7 Considerations in a Risk Assessment7.1 Pre-designed products or components (design)

7.2 Product use

7.3 Vulnerability of users

7.4 Hazards7.5 Nature of injury

7.6 Probability

7.7 Risk level

8 Risk Assessment Methods

8.1 Hazard Analysis and Critical Control Points

8.2 Risk priority number

8.3 Failure mode and effect analysis

8.4 Fault tree analysis8.5 Nomographs

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Section III Explaining the Requirements of the Global Standard

1 Senior Management Commitment and Continual Improvement

1.1 Safety and quality objectives1.2 Review process and evaluation

1.3 Records, documentation and communication of the review

1.4 Provision of resources

1.5 Staff responsible for the Global Standard shall report regularly to seniormanagement1.6 Site shall have a copy of the Global Standard

1.7 Approval by the authorities

2 Risk Management

2.1 Product scope and group determination2.2 Legislative and safety requirements

2.3 Risk assessment prior to production

2.4 Verification of the product risk assessment

3 Management System3.1 Policy statement

3.2 General documentation requirements

3.3 Organisational structure, responsibility and management authority3.4 Internal audit

3.5 Purchasing, supplier approval and performance monitoring3.6 Customer-supplied property

3.7 Corrective and preventive action

3.8 Traceability3.9 Management of product withdrawal and product recall3.10 Management of incidents and business continuity

3.11 Contract review and customer focus

3.12 Complaint handling

4 Site Standards4.1 Location, perimeter and grounds

4.2 Internal site: factory layout, product flow and segregation4.3 Building interiors

4.4 Staff facilities4.5 Cleaning procedures

4.6 Waste/waste disposal

4.7 Pest control

4.8 Product transport, storage and distribution4.9 Site security

5 Product Control

5.1 Pre-production reference samples

5.2 Chemical formulation control5.3 Product packaging materials

5.4 Control of non-conforming materials6 Product Conformity Assessment

6.1 Product analysis/testing

6.2 Inspections6.3 Product claims

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7 Process Control

7.1 Control of operations

7.2 Control of incoming components and raw materials7.3 Equipment and equipment maintenance

7.4 Foreign-body detection and control

7.5 Calibration and control of measuring and monitoring devices

7.6 Retained production samples7.7 Final product packing and control

8 Personnel

8.1 Training and competency

8.2 Protective clothing

8.3 Hygiene practices

Section IV Guidance for Achieving Certification1 First Steps

2 Planning2.1 Commitment

2.2 Team building

2.4 Deciding the product group2.5 Carry out a self-assessment or gap analysis

3 Preparation3.1 Documentation

3.2 Evidence and fact

4 Selection of a Certification Body4.1 Accreditation4.2 Scope

4.3 Audit teams and other visitors

4.4 Consistency of certification bodies

4.5 Code of conduct4.6 Customer preferences

4.7 Location4.8 Resources and service

4.9 Applications4.10 Contract

4.11 Pre-assessment audits

5 Preparing for the Audit Visit

5.1 Choosing a date5.2 Availability of staff and information5.3 Auditor facilities

6 The Audit Visit

6.1 The opening meeting6.2 Auditor activities and time on site

6.3 Document reviews6.4 Facility inspection

6.5 After the site visit

6.6 Closing meeting6.7 Tips for the audit visit

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7 After the Audit Visit

7.1 Handling non-conformities and corrective action

7.2 Revisits7.3 Review of documentary evidence

7.4 Timing

8 The Audit Report

8.1 The report format8.2 Report ownership

9 Certification

10 Use of the Logo

11 The Directory

12 Feedback13 Further Support

Summary

Main Differences

Appendix: Differences between Issue 3 and Issue 2ASummary

Main Differences

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SECTION IOVERVIEW

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Section IOverview

1 Introduction

This guideline is intended to help you understand and implement the Global Standard forConsumer Products Issue 3(henceforward referred to as the Global Standard). It builds

on the information in the Global Standard and provides an expanded explanation of the

certification programme, the requirements and the audit process. It does not repeatinformation contained in the Global Standard and you will need a copy of the GlobalStandard for reference when studying this guideline.

This interpretation guideline is generally applicable to manufacturing and assembly-packing sites and is not intended for any specific industry sector. In some cases, sector-specific guidelines are also available. This guideline will also be useful for auditors and

those sites requesting that their suppliers adopt the Global Standard.

1.1 Why is the guideline needed?

The requirements of the Global Standard contain clear statements that can be evaluatedby an auditor during an audit visit. The auditor can then make an assessment of whether

the site has met each of the requirements. The clauses of the Global Standard aregenerally short statements without explanation. The Global Standard does not define the

means by which a site fulfils the requirements (indeed this may vary from site to site),nor is it possible to include detailed explanations of the intention or background of the

requirements in the Global Standard.

The Global Standard tells a site what needs to be achieved, but does not explain how it

should be achieved, or why. This guideline helps to fill in the gaps so that sites seeking

certification, auditors and retailers can gain a better practical understanding of what is

required. It gives sites an indication of what an audit visit might entail, and the kind ofinformation and evidence an auditor will look for.

This guideline contains:a detailed explanation of the certification programme

guidance on risk assessmentan enhanced explanation of each clause of the Global Standard, with practicalexamples

information and guidance about the audit process and audit visits.

1.2 Status of the guideline

This guideline has been produced to help sites meet the requirements of the Global

Standard. It is not essential to have a copy of the guideline or to follow every suggestionin it in order to obtain certification. Its main purpose is to provide support for sites thatare looking to obtain certification but are unfamiliar with the Global Standard and how to

fulfil its requirements.

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Sites are audited against the Global Standard, not the guideline. Therefore, a site is able

to adopt its own approach to tackling the requirements if it so wishes. The British Retail

Consortium (BRC) always welcomes additional suggestions or improvements and mayinclude interpretations and updates on its website from time to time:www.brcglobalstandards.com. This interpretation guideline is complemented by a series

of BRC best-practice guidelines, which provide in-depth considerations of issues such as

pest control, complaint handling, foreign-body detection and internal auditing.

2 General and Background InformationWhat follows is some useful background information on the Global Standard, which willhelp those sites considering certification understand more about it. It explains why the

Global Standard exists and has evolved to Issue 3, the advantages of obtainingcertification, the likely level of investment, and the resources and time necessary to bringa site to the level required for certification. It also helps sites to compare the

requirements of the Global Standard to their current systems for quality and safety.

2.1 Summary of the Global Standard

The Global Standard for Consumer Productsis, as its title suggests, a standard about

consumer products that can be used globally but it helps to know a little more. Mostimportantly, the Global Standard is about the safety, legality and quality of products. Inorder to apply the Global Standard, a site must be manufacturing or contract/assembly

packing consumer products.

Examples

A company imports g iftware products, whi ch it suppl ies to a retailer for its private-label range. Theretailer has told the company that it needs to obtain certification to the Glo bal Standard.

The Global Standard is not applicab le to importers. The importer can request its manufacturermeets the Global Standa rd.

A company imports pens, pencils and erasers in bulk, wh ich it packages in to stationery sets for theconsumer.The company may be considered an assembly packer, and the Global Standard is applicable.

The Global Standard does not cover issues such as worker safety, protection of theenvironment, social and ethical issues, or sustainability. These are all important topics

but the Global Standard is completely focused on products and helping to ensure thatthey are safe, legal and made to the required quality. The Global Standard has been

produced by experts in these areas.

Those auditing the Global Standard are required to have substantial expertise and

experience in the safety, quality and legality of products within the scope of the auditingcompetence.

The Global Standard is a voluntary, private standard produced by technical committees

comprised of retailers, with input from a number of other stakeholders. The Global

Standard is owned by the BRC and Issue 3 has been developed in partnership with theRetail Industry Leaders Association (RILA) in the USA. It is designed to meet the needs

of retailers and their customers, and help sites ensure that suitable products reach themarketplace.

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The Global Standard does not replace or conflict with product-specific standards

(whether voluntary or mandatory) or any legal requirements. Indeed, the requirements ofthe Global Standard include checks to ensure that manufacturers are aware of and meettheir obligations in this respect.

Examples

A company prod uces toasters for export to Europe and has been test ing product s for electrical safetyto EN 60335-2-9. It is concerned that the Global Standard does not include this test.

The Global Standard is not a specific test standard. It is an auditing standard, which ensures thatcompanies can consistently manufactu re in accordance with its requirements. The auditor wouldexpect the company to show that it knew and kept up to date with the product standards relevant toits products (including EN 60335-2-9).

A company prod uces cosmetics for the global market and follows an industry gu ide for good

manufacturing practice (GMP). It is concerned that the Glo bal Standard will create extra work.The Global Standard is applicable to mo st types of consumer product and is written in generalterms. It is very unlikely that it will conflict with more specific requirements and, if a company

already has procedures in place, this is likely to make implementation of the Globa l Stand ardeasier. The Global S tandard covers many aspects, including GMP.

A common question concerns the difference between the Global Standard and ISO 9000

(the standards for quality management systems). In simple terms, the difference isaround the Global Standards focus on products. In order to meet the requirements ofthe Global Standard, a site has to define the scope of the products for which it wishes to

be certificated and the regions of the world in which it intends to sell those products.

Many of the clauses in the Global Standard are specifically related to products such asthose on product conformity, risk assessment and hygiene. ISO 9000, on the other hand,is about management systems. The Global Standard includes a number of clauses

about management commitment and management systems, and a site that hasachieved ISO 9000 will be in a good position to meet the requirements on these matters.

Another difference is that the Global Standard is part of a centrally controlled certificationprogramme with comprehensive checks and balances in place. ISO 9000 certification is

offered by many organisations and there is no single point of control. Many of the

approved certification bodies that carry out audits to the Global Standard also carry out

ISO 9000 audits, and it is possible to combine these visits if required. Further informationon these services can be obtained directly from the certification bodies.

More detail of the similarities and differences between the Global Standard and ISO9000 can be found on the BRC Global Standards website

(www.brcglobalstandards.com).

Figure 1 illustrates how the Global Standard overlaps with other quality assurance

systems.

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owner can choose who has access to detailed information such as audit reports, and

whether they wish the certificate to be available on the public website. The audit

processes are addressed in more detail in Section IV of this guideline.

The BRC and RILA do not carry out any audits themselves. Audits are carried out by

approved certification bodies that have to sign a contract agreeing to follow certain

requirements. Certification bodies must be independently assessed (known asaccreditation) for their competence by one of the national accreditation agenciesresponsible for checking the systems and competence of the auditors. The BRC

maintains a list of the accreditation agencies it works with. Certification bodies have tobe audited every year to ensure that they are performing correctly. Any justified

complaints received by the BRC about certification bodies are investigated by the BRC

and referred to the appropriate accreditation agency for consideration.

2.3 The benefits of certification

There are numerous ways to assess whether certification will be of value to your site. As

well as the direct value of being able to trade with a particular client, who may haveinsisted you become certificated as a requirement for business, there are many other

advantages of certification:

Implementation of logical processes and procedures leads to a more consistent andefficient operation with a better use of resources.Documenting processes and procedures helps to prevent mistakes, rework or recalls

and makes investigations into any problems much easier.

It provides a competitive advantage over sites not yet certificated, especially givencurrent concerns about product safety, and may lead to increased sales.It can provide evidence of good practice and a certain level of defence when

problems do occur. It may even reduce insurance premiums.It enables your site to be benchmarked against industry best practices, and routine

audits assist sites with continuous improvement.

The global nature of the Global Standard may open up trade opportunities in newcountries or regions.Visibility on the BRC Global Standards website (www.brcglobalstandards.com), is

viewed by many of the worlds leading retailers and other customers.It ensures that there is a framework in place to keep up to date with safety legislationand current safety concerns.

There is a high level of prestige for a site that achieves certification to the Global

Standard.Implementation of the Global Standard provides an excellent training tool for staff.

It is essential, however, that a site becomes familiar with the Global Standard and

studies it in detail before rushing into certification. There are many sources of advice and

information (including certification bodies, retailers, consultants etc.) who can advise onthe best way forward.

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Examples

A company produces children s boo ks. It has a problem with a sound chip de taching from the bookand, as this is a possib le chokin g hazard, needs to carry out a recall. It cannot identify the faultybatch so has to recall all product s from 26 countr ies. A similar company, bu t with t he Global

Standard in place, needs to recall childrens shoes that have a faulty decoration. Because its

traceabili ty system complied with the requirements of the Global Standard, it is able to trace theproblem to a small batch of product and conduct a l imited recal l of a small delivery in o ne coun try.

This demonstrates how the systems put in place to meet the requirements of the Global Standardcan have direct practical benefits for a company.

A producer is making bicycles for the European market when it is asked to fulfil an order by a newclient in Australia.Using the system it has put in place to meet the requirements of the Global Standard to keepupdated on pro duct safety standards an d legislatio n, the company is quickly able to identify that,althoug h the product standards in Australia a re different from those in Europe, which was theregion of intended sale, it can adapt to the requirements and is able to meet the order.

2.4 The cost of certification

The cost of certification will vary greatly from site to site and will depend, to a largeextent, on how close a site already is to meeting the requirements of the GlobalStandard.

It is likely that much of the cost of achieving certification will be incurred by the worknecessary to fulfil the requirements of the Global Standard, rather than the actual audit

cost.

The final cost of certification will comprise:

Purchase of the Global Standard (it is a requirement for a site to be in possession of

a legal copy of the Global Standard in order to achieve certification).Purchase of any guidelines required (optional).Upgrading equipment or buildings to meet the requirements, where this is important

for product safety.

Management time to prepare and implement new procedures, or improve existingones.Staff training about the Global Standard and any new procedures required.

External consultancy or advice (as necessary).

A pre-assessment visit (optional).The audit visit.

Correction of any non-conformities raised.The BRC registration fee.

2.5 The value of certification

Sites should balance the cost of gaining certification against the benefits of having amore robust and controlled system in place, and the confidence to produce safe and

legal products. This is likely to lead to an enhanced reputation and the possibility of

greater sales.

The Global Standard is not prescriptive about the format of any documentation or the

way in which sites show compliance so, if a site already has good procedures in place

which cover all aspects of the Global Standard, costs will be largely limited to thepurchase of the Global Standard, the audit visit and the registration fee.

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The Global Standard is suitable for a wide range of operations, from small sites making

one simple product type for a local market to large sites making a wide range of products

for international markets. The complexity of the product type, the level of risk the productmight present and the amount of legislation surrounding the product will also affect theamount of work required to meet the Global Standard. This, in turn, will affect

implementation costs and the length (and therefore cost) of the audit visit.

The BRC or RILA do not control the cost of the audit visit. This is set by the certificationbody and is governed by market forces. The certification body will typically ask you for

some information about your site and products (often in the form of an application packor questionnaire). It will then provide you with a quotation detailing the length and cost of

the audit, as well as any extras such as expenses for travel and subsistence. Quotations

are affected by a number of factors, including the availability of an auditor withexperience in the relevant product sector, workload, different pricing structures andlocation, so it may be worth shopping around.

The BRC registration fee is payable at each certification. The fee is collected by thecertification body on behalf of the BRC. This fee includes registering the site on the BRC

Directory and helps to support other services such as compliance management,newsletters, updates etc.

Despite the initial outlay, implementation of the Global Standard may result in substantialsavings brought about by improvements in efficiency and management control.

2.6 Time to achieve certification

The time needed to gain certification is dependent, like the cost, on how close the site

already is to meeting the requirements of the Global Standard, and how complex theoperations are.

Auditors will expect to see a working system in place and evidence that actions havebeen completed and records kept. A template created just before an audit visit, withoutany actual data recorded onto it, is not likely to be sufficient to convince an auditor that

the operation is working consistently and well.

For a new site, once the management is confident that the Global Standard has been

implemented, the systems should operate for a minimum of three months before the site

seeks certification. Sites that already have procedures in place and are migrating to theGlobal Standard after experience of other programmes may be able to complete theprocess within a shorter timescale.

Sites that aspire to become certificated to the Global Standard and are working towards

certification may register on the scheme and undergo an initial audit even though theymay not be ready for certification. This allows sites to establish a gap analysis and work

on the aspects that need improvement. It also means that their customers (retailers orothers) are able to track their progress towards certification.

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Most certification bodies offer a pre-assessment audit to help a site gauge where it is

with regards to certification, and enable it to work on any the gaps in its system. In order

to avoid a conflict of interests, certification bodies are not allowed to offer consultancyand advice unless they have a separate consultancy division. There are, however, anumber of consultants who can help sites meet the requirements of the Global Standard.

2.7 Will it be too difficult?

Many sites have concerns about implementing the Global Standard. A smaller site, for

example, may not be familiar with independent assessment against a standard, or it

may have particular concerns about its products (small runs, seasonal items, speedfrom production to market etc.). Then, of course, there are concerns about theinvestment needed in both money and time, and whether there are sufficient resources

or expertise available.

Do not be intimidated by the Global Standard. Instead, purchase a copy and study it indetail. Most of the requirements are normal business practices and a site may find that it

is already doing most of what is required, even if it does not have all the procedures ordocumentation in place.

If a site requires capital investment or changes to the building layout in order to achievecertification, it should consider whether this investment may bring other businessbenefits. The Global Standard is not generally prescriptive about how sites meet the

requirements and it may be possible to identify less expensive means to achieve the

same objectives. The Global Standard includes requirements to ensure the safety andquality of products. If products are not being produced using the principles behind theGlobal Standard are you confident that you can ensure their safety and legality and that

they will consistently meet your customers demands without costly rejections andreturns? Consumer expectations and product legislation are becoming ever more

demanding, so consider whether working towards the Global Standard now will help you

to adapt to the market in the future.

2.8 Scoring and continuous improvement

When a site is awarded certification it receives a grade which is determined by the

number and severity of the non-conformities discovered during the audit visit. Each siteis also awarded a score. This score is allocated during the audit visit by the auditor

completing the BRC checklist of questions. More information about the checklist isavailable on the BRC website (www.brcglobalstandards.com). It is not included in thisguideline as it needs to be updated and modified from time to time.

All sites are scored whether or not they achieve certification. Unlike the audit grade,the scores are not published on the public website, nor do they affect the frequency ofaudit visits.

In addition to the scored questions in the checklist, there are a number of critical failurequestions. These questions relate to critical failure points or substantial failures to meet

fundamental requirements of the Global Standard. Such failures automatically lead to afailed audit.

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Site scores are made available to those retailers and other partners to whom the site has

chosen to reveal its full information. Retailers can use the scores to compare sites and

identify any problem areas.

This system allows sites that are not yet ready for certification to undergo audits and

register on the BRC Directory. It also allows a site working towards BRC certification to

show continuous improvement as its audit scores improve over time.

This approach also gives retailers visibility of the performance of sites that do not yet

meet the full certification requirements so that they can form an opinion about whether ornot to use that supplier.

Un-certificated sites do not appear on the public directory of certificated sites.

2.9 The history and background of the Global Standard

The idea for a Global Standardto help ensure the safety and quality of non-food

products originally came from large retailers in the UK. These retailers had becomeaccustomed to working with the BRCs Global Standard for Food Safety, found it helpful

and wanted something similar for the non-food items on their shelves. One of the drivers

for such a standard was the introduction of the General Product Safety Regulations intoUK law in 1994. This law introduced, for the first time in the UK, a requirement that all

consumer products were reasonably safe and that manufacturers and others in the

supply chain had a duty to make sure that this was the case. When unsafe products

were found to have been sold to consumers, it was a defence against legal action if sitescould show that they had taken all reasonable steps to prevent a problem occurring. Thisis commonly referred to as a due diligence defence. Retailers considered that the use of

a standard programme for their suppliers would help them in these cases.

A committee of technical experts began working on the first issue of the Global Standard

but it soon became apparent that it was not easy to cover the whole range of producttypes, and that there was little experience in the industry for such a new approach tonon-food product safety which had previously relied almost entirely on pre-shipment

inspections and some testing. Nevertheless, the first issue of the Global Standard waspublished in 2003.

In 2006, after valuable experience gained from the first issue, an improved and revised

standard was published. With the second issue it was possible to achieve consistentresults when audits were carried out by various certification bodies. The accreditationbodies were satisfied (on the basis of an international guideline for product certification,

ISO/IEC Guide 65) that the Global Standard was robust and began to accredit the

certification bodies that performed the audits. This became the basis for the current

scheme.

After two years, Issue 2 was finding wider appeal and being used internationally by bothmanufacturing sites and retailers, so a minor revision (Issue 2A) was produced to

remove some UK-specific references. The requirements for the sites did not change

between Issues 2 and 2A. Issue 3, to which this guideline refers, reflects a growinginternational aspect, as demonstrated by the partnership between the BRC and theRILA. The Global Standard can now be considered truly global, with translations in a

number of different languages.

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This current Standard addresses the changes that have taken place in consumer

product safety over time and takes account of the fact that there is now more regulation,the market for products is international, and new, innovative products are beingproduced which need to meet increased consumer demands for quality and safety.

Implementation of the Global Standard helps to address these issues in a cost-effective

and efficient way.

2.9.1 Previous issues of the Global Standard

Issue 3 builds on the previous versions of the Global Standard, so sites that have

achieved certification to Issue 2 or 2A should be able to progress to Issue 3 without anymajor changes to their systems and procedures although there are several new

requirements and several sections have been rationalised or re-ordered. A table of the

major changes between Issue 2A and 3 is in the Appendix of this guideline.

The certificates of sites that have achieved Issue 2 or 2A of the Global Standard remain

valid until the date of renewal, at which time they must be audited to Issue 3.

Sites being audited to Issue 3 of the Global Standard must be in possession of a validcopy of Issue 3.

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SECTION IIPRODUCT GROUPS AND RISKASSESSMENT

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Section IIProduct Groups and Risk Assessment

The detailed requirements of the Global Standard differ according to which of the threegroups a product belongs. This ensures that the audits are suitable for the product type

being manufactured. Some requirements, such as a management commitment to

product safety, are essential for all product groups, but others are only required forproducts that potentially present a higher risk. The intention of the Global Standard is tobe appropriate for the manufacture of safe and legal products of the desired quality, and

not to put an unnecessary burden on producers. This is why there are fewerrequirements for products in Groups 2 and 3 than for those in Group 1.

Example

A company making lipst ick, which wil l be placed on the skin and in close contact with the mouth,shou ld pay more attention to hygien ic practices than a company making bricks.

The lipstick will be a Group 1 product as this is where most hygiene issues are addressed. Thebricks will be in Group 2 or 3, depending on the exact nature of the products.

Sites must first define the scope of the products that they wish to cover within their

certification and then assign those products to a product group. When deciding a productgroup, the site must begin by looking at the risk level of its products. This section of the

guideline identifies why risk assessments are important when assigning product groups

and explains in some detail how to assign products to a group. It also explains thefundamentals of risk assessment and some of the more common approaches to carrying

one out.

1 Defining Product ScopesCertification is specific to an individual site and if a company has more than one location,

each site must be audited separately. It is frequently the case that a site applies to becertificated for all the products it produces on the site but, in some cases, it may want tolimit the certification to only part of its range of products. The product scope must reflect

only those product types included in the certification.

There are a number of issues to consider when defining the product scope:The product scope chosen must be precise enough for the auditor to be able to

determine whether the requirements of the Global Standard can be achieved by thesite for the range of products stated. The definition may include product types, and

the technology used to produce them may also be an important consideration.

Examples

It would no t be acceptable to sta te pla stic items as a scope. It would be acceptable to stateinjection-moulded plastic handles and furniture fittings.

The term cosmetics wou ld be too broad for an auditor to assess , but describing the produc ts asshampoo, shower gel and hair conditioner wou ld be acceptable.

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The scope should not include brand names or retailer names but be a generic

description of the product. Certification to the Global Standard applies to the systems

and processes on the site. It would not usually be acceptable to request certificationfor only one retailers product if other very similar products are being produced usingsimilar processes. At the very least this would question management commitment,

which is essential to the Global Standard.

The scope should not normally be so specific as to exclude similar productsproduced using similar technology, especially if they are produced in the same

production area. This would unnecessarily limit certification and show a lack ofunderstanding of the aims of the Global Standard.

Examples

A company has a certificated operation for the production of yellow d usters. A client wants them toproduce green dusters.

Its cert if ica te d oes n ot inc lude this p roduct in the scope. The retai ler may want to carry out extrachecks to understand whether the dusters are made in a safe manner. This example indicates theneed for a company to think carefully about product scopes. It is probably in a companys best

interests not to limit the scope unnecessarily.A scope has been defined as injectio n-moulded to y parts. When an auditor visi ts the site themanager show s them a blow-moulding operation, which the site also wants included in the audit.The certification body will not have allowed for this in the visit plan. It may be that the auditordoes not have expertise in blow moulding.This example shows how careful pla nning with regardto product scope and information passed to the certification body is essential.

It is possible to combine very different operations in one certification and one auditprovided they are produced on the same site and clearly stated.

Example

A toy factory is making plastic toys, soft textile toy s and electronic toys.One certificate can be awarded provided the scope is well defined.

It is necessary to identify the geographical areas in which a product is intended for

sale. This is because safety and/or legal requirements for many products vary from

place to place, either because of different perceptions about safety or because ofdifferent use patterns. Depending on the product type, it may be adequate to specifya region (such as Europe or the USA) but for some products, requirements may be

specific to individual states or cities and, if necessary, these should be defined or

specifically excluded. The Global Standard requires sites to have a system to showthey are aware of, and meet legislation applicable to, their products in the areas ofintended sale.

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Examples

A company is packing b ott les of shampoo in to a gift pack with a comb and brush set.Al though sham poo as a cosme tic wou ld no rma lly fal l wi th in Prod uct Gro up 1, in th is case thesham poo is in sea led bo ttles an d so i t is not appropriate to apply al l t he requ irements o f Product

Group 1. Therefore, the operation would be Product Group 2 if extra labelling is required, or

Prod uct Gro up 3 i f a ll the required label ling is already on interior packages.Bulk supplie s of aspirin table ts are received by a packer who packs them into individual foil wraps.The bulk product is potentia lly exposed to contamin ation a nd the packaging must contai n thecorrect informa tion. This site is treated as a manufacturer, and its product would be in Prod uctGroup 1.

2 Assigning the Correct Product GroupThe correct product group for the products being produced must be selected. One groupis not better than another; each group is intended to be appropriate for the products

concerned. When products fall into more than one product group, the higher groupshould be used for the complete audit unless the operations are so separate that they

can be assessed independently. This can also apply when a company produces a range

of goods at different times of year although it should try and arrange the audit at a timewhen higher-group products are in production.

With such a wide range of products covered by the Global Standard, it is inevitable thatsome items will be difficult to categorise, and there will be some differences of opinion

and borderline cases. The BRC will try to address some of the recurring issues with thehelp of technical advisory committees, and post guidance on the website. However, it will

not be possible to take a view on every item. It is for the site applying for certification tospecify and justify the product group to which it wishes to be audited. If the chosen

certification body does not agree with the decision, the procedures in the GlobalStandard can be followed.

A site cannot simply choose the product group it would like to use. The product group

has to be justified using the decision tree in the Global Standard and any additionalrelevant information pertinent to production.

The selection of the product group should be regularly re-assessed because new

legislation about product safety and the development of more standards means thatproducts, which in the past were not subject to mandatory requirements, may well be inthe future.

2.1 The difference between manufacturers and packers

In the Global Standard, there is one product group decision tree for manufacturers(Global Standard for Consumer Products Issue 3, Figure 2) and one for assembly

packers (Global Standard for Consumer Products Issue 3, Figure 3). This is becausepackers may be assembling finished and packed goods into larger sets and theindividual items will not be exposed to the same hazards as if they were actually being

produced. The decision trees also allow for when exposed products are packed and, inthis instance, redirect the user back to the appropriate level of the manufacturing

decision tree.

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Examples

A company is packing b ott les of shampoo in to a gift pack with a comb and brush set.Al though sham poo as a cosme tic wou ld no rma lly fal l wi th in Prod uct Gro up 1, in th is case thesham poo is in sea led bo ttles an d so i t is not appropriate to apply al l t he requ irements o f Product

Group 1. Therefore, the operation would be Product Group 2 if extra labelling is required, or

Prod uct Gro up 3 i f a ll the required label ling is already on interior packages.Bulk supplie s of aspirin table ts are received by a packer who packs them into individual foil wraps.The bulk product is potentia lly exposed to contamin ation a nd the packaging must contai n thecorrect informa tion. This site is treated as a manufacturer, and its product would be in Prod uctGroup 1.

3 Using the Decision TreesThe decision trees are used to help sites decide into which product group their productsbelong. Most of the questions are precise and have definite answers, although some

research may be necessary to establish the answer.

The most difficult questions are those relating to whether products can cause death or

serious injury/harm. There could be insufficient data available to make a clear decisionbetween minor and major injury, and it may depend on what is considered to beforeseeable use. Risk assessments may help to establish an answer. It is recommended

that the reasons for any decision based on the product causing or not causing seriousinjury is documented and justified, and the result of a consultation process.

In the case of true borderline decisions, the requirements of the higher product group

should be met.

A few examples of how to work through a decision tree are posted on the website(www.brcglobalstandards.com). They are not included in this guideline becauserequirements for consumer products change quickly and specific details soon become

out of date and in need of revision.

A point of confusion sometimes arises when sites have put measures in place to controlhazards; the analysis using the decision tree should consider the intrinsic hazards

relating to the product and process even if an individual site has methods to prevent

them.

Example

A site i s producing clothing for babies. It has a metal detection system in place to prevent anybroken need les or o ther metal parts reaching the consumer and potentia lly causing injury.Al though the factory may have a goo d con trol sy stem an d be con fiden t tha t i t works, whenassessing the product group, it mus t consider the level of hazard witho ut taking account of the

control. If metal contaminatio n is theoretically possible and can p roduce a risk to the consumer,this must be taken into account.

3.1 Product Group 1

The defining characteristic of Product Group 1 is that products in this group need to be

produced in hygienic conditions. This may be because it is a legal requirement or

because microbiological contamination is a potential risk.

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Products that need to be clean but that do not themselves support microbiological

growth, or are handled in such a way that hygienic conditions during production are not

relevant to the final product, should not be considered in this group.

Examples

Ceramic tableware for food use.The surface of ceramic materials does not easily support microb iological g rowth, products are

commonly washed before use and products are frequently transp orted in a n unwrapped state,which would negate most of the hygiene controls on site. Such items would be Product Group 2.However, some count rie s may have a legal requirement to make such products under goo d

manufacturing practice and, if so, these products would then move to Group 1.

Tampons.These products are used invasively and are likely to remain in the body for more than 30 minutes,so are Product Group 1.

Bubble-blowing liquid.This is a product for use by children, may support microbiological growth and may be stored forsome t ime bef ore u se. A ltho ugh normal detergen ts for adu lt us e wou ld n ot normally be G roup 2,and toys would usually be Group 2, it is foreseeable that children could i ngest the material and soit is classed as Product Group 1.

3.2 Product Group 2

This is probably the group into which most products would be categorised. This isbecause many products have the potential to cause harm if the design, materials or

manufacturing process is not well controlled. Additionally, more and more consumer

products now have product-specific legislation concerning safety or quality.

In some countries, the designation of some product standards as mandatory is commonpractice. In Europe, some standards are defined as harmonised standards, which havea quasi-legal status. It has been decided by the European Commission that compliance

with these standards may be used in most circumstances to show that products arereasonably safe. There is a definition of harmonised standard in the glossary of the

Global Standard.

It should be noted, however, that most product standards are voluntary standards. Themajority of standards published by bodies such as ISO, CEN, ANSI, ASTM, BSI and DIN

are not compulsory. Products covered by these standards do not necessarily fall intoProduct Group 2 unless the standards have been awarded a special harmonised ormandatory status or the product meets other criteria for this group.

Similarly, a product that requires risk or safety labelling is included in Group 2 butvoluntary labelling of a product does not automatically mean the product should be in

Group 2.

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Examples

Toys.Almost al l coun tr ies have (of ten complex) legi slat ion for the sa fety of toys. Toys wil l never belower than Group 2 alth ough some may be Group 1.

Outd oor furniture.

A harmoni sed standard (EN 581) exi st s fo r such furniture on the Eu ropean m arke t and so, in th iscase, it would be Group 2. Similar products made for other markets do not have mandatorysta nd ards and so the product group would be judged on whet her it cou ld cause death o r ser iousinjury and, depending on this risk assessment, placed in Group 2 or Group 3.

Carpets and rugs.

The USA has a mandatory stan dard concerned with the flamma bility of do mestic carpets andrugs, which would mean that such products are Group 2. This may not be the case in otherjurisd ictions.

Garden chemicals.Most cou ntries h ave lega l requ iremen ts for labelling toxic chemica ls such as pesti cides and weedkillers. These products would be in Group 2 for this reason and because they could cause seriousharm.

Ladders.In many places the st andards and warning s on ladders a re voluntary. However, well-documented

evidence of injuries to people falling from lad ders would suggest this product should be in Group

2. Note that the problem in this case could well be due to the person rather than the productmanufacture but because there is potential for in jury due to a product failure it is still in Gro up 2

3.3 Product Group 3

This group is intended for low-risk products. Previous versions of the Global Standardused to categorise this group as having no applicable specific safety legislation, and any

such products would still fall into Group 3 unless they had the potential to cause serious

injury or death. With the advent of new chemical legislation in many countries, manymore products have to meet legal requirements concerning the safety of chemicals usedin products. Where chemicals are contained in articles (rather than used in preparations

such as shampoo or liquid detergent) and the right starting materials are used, provided

no further hazards are introduced because of the product process or the product design,such items may still fall into Group 3, as long as other criteria on the decision tree are

consistent with this category.

Examples

Textile shopp ing bags.In Eu rope, textiles in p rolonged contact with the skin, such as bag hand les, must be free of bannedazo dyes. Provided azo-free material is sourced to make the bag, and this can be demonstrated, the

bag is likely to fall into Product Group 3 as a low-risk item.

Writing paper.This is considered to be a low-risk product with no particular requirements. Finger cuts frompaper edges are de fined as a minor injury s ince they are usual ly co mplete ly cured af ter a few days.

Desk accessories.

Item s such a s penci l holder s, mo use mats and coas tersdo not h ave any particular requirementsand would usually fall into Group 3 unless they are specifically intended for children.

4 Process of Risk Assessment the BasicsThere are many places in the Global Standard where risk assessment is mentioned.Users should not be intimidated by this. A risk assessment usually involves applying alogical thought process to an issue and writing down the outcome. In some (but no

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means all) cases, research might be necessary or specific knowledge and expertise may

need to be applied.

The principles of risk assessment are very simple and designed to ensure that care istaken where it is needed and that issues are addressed proactively (rather than once

they have happened). A risk assessment involves the systematic evaluation of any

hazards that a product could present and an assessment of the likely exposure oroccurrence during use or foreseeable use.

A risk is the hazard multiplied by the exposure. Therefore, some things that are veryhazardous are of low risk because there is almost no chance of them happening.

Risk assessment principles can be applied to many situations. This guideline focuses onthe safety or legality of a product, but risk assessment techniques can also be used toevaluate financial risk or risk to a brand name. In the context of the Global Standard, risk

assessment is considered in terms of the safety of the initial product design and

materials, the potential for hazards being introduced during or after production, orindividual concerns or problems forming part of the site operation or management.

Examples

Tigers are dangerous wild animals, hazardous to humans.In an of fice no body worries a bout being attacked by a t iger. Such animal s are rare and, if they arein the area at all, they will be in a zoo. Even if one escaped, the chances of it entering a buildingand attacking someone are minute. A situation of high hazard but very low risk.

Kittens are small and considered to be no danger.

At fi rs t s ight th is a ppear s a reasona ble statement, bu t pets such as kit tens are known to cau seasthma attacks in vulnerable people. The kitten therefore poses a hazard and, depending on thesi tuat ion, a risk assessmen t may show the kit ten to be m ore o f a risk than the tiger.

A manufacturer of cots has a new design with a fretwork panel. On review, the holes in the panel maybe of such a size that babies could get their fingers s tuck in them.The manufacturer has to decide whether this is actually the case and, if so, whether children canreally place fingers in the holes or if it is just a perceived problem. If they can get fingers into the

holes, will there be a chance of injury? This is a risk assessment.A company needs to decide whether to supply workers with protective gloves.

The compa ny considers why gloves are needed is it to protect the worker or the product? Is thereany evidence to suggest that workers may need protection? Is there a likelihood that gloves couldcontaminate the product? What is the risk to the product or worker if they do not wear gloves?

Sometimes levels of risk have to be considered. In this case, protecting workers may lead to anincreased product risk and an alternative solution may be required.

In order to fully understand those aspects that are important to a products safe

manufacture and use, it is advisable to carry out a formal risk assessment. The amountof detail necessary for this will depend on the product type, the amount of data aboutrisks that is available, and the experience of the site.

It is usually the products that are not well known to the site, and possibly outside thecore range of its production, that require the most effort. Sites should be particularlyvigilant when supplying products to a new customer type (e.g. children) or in a new

marketplace (e.g. the USA when already supplying into Europe).

Risk assessment is not the same as product testing and should not be confused with it,although test results are likely to be incorporated into the risk assessment.

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Just because a product has passed a standard test, a risk assessment may still be

necessary. This is because, for example:

there may be safety issues not covered by testing to the existing product technicalstandardsproducts are usually tested when they are new, and certain problems may only arise

after prolonged use

it is usual that only a very small number of products are tested, so product variabilitymay need consideration.

Examples

Over the last few years toys have been recalled because they con tain po tential ly dangerou s smallmagnets.There was no test for magnets in the Toy Standard and, for a long time, the problem was notidentified. Hospital data led to a re-assessment of the risk. It was found that some toys includedvery strong magnets and that children sometimes ingested them.

A producer of a swing frame had to recall products because the su pporting cross-bar rusted throughvery quick ly and there was potenti al for a child to fall.

The product had passed all the required safety tests. It was found that the design allowed water tolie in the cross bar which rusted over time, weakening the support.

An iron is tested and found to meet the safety test requirements. The company receives complaintsbecause the e lectrical flex is de tach ing from the body of the product.The assembly of the products is found to be variable, and some of the cable clamps used were nottightened sufficiently to support the flex.

Different industries have different approaches to risk assessment and use a range ofterms to describe the process, such as HACCP (Hazard Analysis and Critical ControlPoints), FMEA (failure mode and effect analysis), RPN (risk priority number) and many

more. There are different ways of conducting risk assessments and there is a variety of

software packages and semi-automatic methods available. A site must decide whichmethod or combination of methods is most suitable and whether the use of any suchaids will be useful. It should bear in mind, however, that the eventual outcome of the

assessment is only as good as the data provided and the level of understanding about

the product. An international standard, ISO/IEC 31010 Risk management Riskassessment techniques gives details of a number of approaches. The BRC does not

advocate any particular system but sites should expect auditors to question how theyhave determined the risk posed by their products and the steps taken to manage suchrisk.

5 Product and Process Risk AssessmentRisk assessments commonly fall into two parts: risk assessment of the product design

and materials, and risk assessment of the manufacturing process.

5.1 Risk assessment of the product design and materials

A risk assessment of the product design and materials is essential to ensure a safe andlegal product. This assessment should address matters such as:

The materials used in the make up to ensure that they have the correct mechanical

properties such as strength and durability.

The chemical composition of materials to ensure that toxic or dangeroussubstances are not used.

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The assembly of the parts to ensure that the materials work together (for example,

the correct type of adhesive).

The mechanical assembly for example, screwing, gluing etc.The technical features of the design such as the shape of moulds, the fit ofcomponents etc.

It is likely that the assessment will be carried out over different stages, starting with theconcept drawings and continuing until the first pre-production samples are produced.Assessment of the product design should then continue based on feedback obtained

from all sources.

Once a site is in routine production, it may not be necessary to carry out a completeassessment for every variant. However, changes should not be made without an

assessment of the new parts or materials, and the likely effect on the product.

Example

A candle maker has a design of candle which it has made and sold successfully and safely for manyyears in a range of colours. It decides to add a dark red colour to the range and assumes it will besatisfactory because of its record.The company receives several complaints about candles flaring up, and is informed of one fire

incident. On investigation, it is found that the red pigment affects the burning characteristics ofthe wax, giving rise to high, smoky flames and unstable burning. A check of the pigmentcharacteristics or a test burn followin g a risk assessment of the change to the original product

may have avoided these problems.

5.1.1 Manufacturing sites with no responsibility for product design

It may be the case that the product design is supplied to a site and that the site has noinput into the risk assessment of the product. In these situations a site sometimes thinksthat the risk assessment process is not relevant, and that all it needs to do is produce

items to the specification it has been given. This has been the cause of a number ofunsafe products getting into the marketplace.

Examples

A battery powered bu bble-blo wing machine is found to overheat and pose a burn hazard. This isbecause the batter ies have been wired u p in a parallel arrangement rather than a series arrangement,

which allows a dangerous condition to occur.On investigation, it is found tha t the manufacturer knew the problem could occur but had madethe products in accordance with the wiring diagram supplied by the customer. The customer had

expected the manufacturer to check and finalise the wiring layout and had provided the plans asan indication of what they wanted. The problem would not have occurred if the risk assessmenthad been checked.

A buyer takes a sample of a childs dress to a factory and asks for it to be produced. A ribbon has

been tied aroun d the dress in order to carry it more eas ily. The factory produces an d ships severalthousand of the items.On receipt, the retailers quality assurance department realises that the ribbon, which was notsupposed to be there, posed a stran gu lation hazard to sma ll chi ld ren and an expensive re-packingoperation was required. The manufacturer h ad followed exactly the clients instructions.

When the product design is supplied to the site it is essential that the site:Has a formal written specification.Is provided with a validated copy of the risk assessment, if this exists.

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Is able to carry out an assessment or commission an assessment if one does not

exist. If an assessment is commissioned the site must validate the capability of the

external party to conduct the risk assessment.Has formally agreed to abide by the content.Has a system in place for communicating key information to the workforce and back

to the specifier, if necessary.

Has a procedure for taking the design risk assessment and producing a process riskassessment, establishing any key control points in the process.

It is not acceptable for a site to produce an unsafe or illegal product because it wassupplied with a faulty design brief.

5.2 Risk assessment of the manufacturing process

This part of the risk assessment establishes any hazards that may be introduced as partof the manufacturing process, and define the points at which control is necessary. Whenthe control is critical to the safety of the product, this is termed a critical control point.

The following should be considered:manufacturing parameters such as pressure, time and temperature

process specifications and toleranceswear of equipment, moulds and machinerypolicies on contamination (e.g. needle policy)

calibration of equipment

quality control sampling, charts and proceduresprocedures for dealing with non-conforming products.

Example

Glass containers are being produced for cafetires (coffee pots with plungers). The retailer receivescomplaints that some of the pots are shatterin g in u se.The producing company has a specification, and a risk assessment has been carried out on thedesign. Suitable materials are being used but it is fou nd that the factory has no t been correctlycontrolling the temperature of the annealing oven or the time the glass is in the oven, resulting ina weak container. Had a proper risk assessment been made on the procedure, the temperature ofthe oven would have been identified as critical and adequate control measures put in place.

Both parts of the risk assessment (product design and manufacturing process) areessential for the reliable production of safe and legal products of the desired quality and

they should be reviewed and validated at regular intervals and when any major changes

occur.

6 Planning a Risk AssessmentFor most products, there are no legislative requirements about who should carry out a

risk assessment but, for an increasing number of products, there is a requirement that arisk assessment is completed and recorded. For a few product types, such as cosmeticsor pharmaceuticals, it is a legal necessity that the suitability and safety of the formulation

is assessed by a person qualified to the requirements defined by the region of sale.

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A site can determine how it wishes to conduct the assessment and whether it is

incorporated into wider product or process control measures. For both product and

process risk assessments the required steps are similar.

6.1 Setting up a team

It is very unusual for one person to be able to carry out the entire assessment and it islikely that a team of people will be required. For example, an engineer who can evaluatethe strength of a moulding may not be able to evaluate the toxicity of the materials used

to make the product.

A suitable team should be assembled to cover all aspects with a designated responsibleperson of sufficient authority to approve the outcomes. The team must have thecommitment of senior management.

This does not mean that a whole range of staff has to be employed for the purpose.While this may be appropriate for very large, complex operations, it is more likely that theduties will form just a part of someones job, or external resources will be used. There

are numerous third parties that provide risk assessment services, but they must becorrectly briefed about the sites products and processes, and which of the

considerations listed in part 7 of this section, Considerations in a Risk Assessment, theytake into account as part of their brief. The final responsibility for the risk assessment willrest with the site producing the items and, at the very least, a staff member there should

coordinate and be responsible for the assessment.

For a product risk assessment the team is likely to comprise some of (but not limited to)the following:

designers

chemistsmaterials scientists

human factors specialists, such as ergonomics experts or child psychologists

engineersquality assurance stafflegal staff.

For a process risk assessment, the team may be made up of:an operations manager

quality assurance staff

engineerschemistsproduction team leaders.

6.2 Team activities

The team should systematically evaluate and record the assessment for each product

and process. It may need to incorporate specialist advice and carry out research into

possible hazards.

When sufficient data clearly establishing risk levels is not available, it may be helpful for

the team to act as (or set up) a panel to evaluate the products and, from the different

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opinions, obtain a balanced view of the issue, which can be recorded as part of the risk

assessment.

The team should also review any accident, complaint or injury data that is received.

The site should have a clear and documented process flow evaluated by the risk

assessment team, and this should allow the product to move around the site in a logicalfashion and minimise any confusion between batches and products.

The team should establish where control points are necessary and whether these arecritical to the safety and legality of the product. They should define what control is

required and have fully documented and approved procedures.

The same team will probably be responsible for managing adverse incidents andtraceability systems for products and materials, and defining measures to handle these

aspects.

A copy of a validated risk assessment should be kept with the product technical file.

7 Considerations in a Risk AssessmentA risk assessment involves the evaluation of all the features that affect the safety of aproduct. It should include details of:

product information about the actual product, its construction and packagingproduct use information about the intended or foreseeable use of the product

user types categories of those using or likely to use the product

hazards property of the product or use that may give rise to harminjury medical injury types classified by severityprobability numerical classification of risk terms

risk combination of the above factors.

Each and every aspect needs to be assessed before combining the information into anoverall risk rating and deciding the acceptability, or otherwise, of the product.

The risk factors in the end product comprise those resulting from the design of theproduct and the materials chosen for its fabrication, and those which may be introducedduring the production, packaging or delivery process. Sites may want to include other

factors such as financial exposure and perceived risk but these are not part of therequirements of the Global Standard.

7.1 Pre-designed products or components (design)

Specified designs and requirements are often submitted to sites, which then produce the

item to meet the specification. In this case, the manufacturer is not in a position to carryout a full risk assessment of the product. Nevertheless, the manufacturer has a

responsibility to ensure that the requested product is not obviously unsafe and that it canproduce the item without introducing unacceptable risks. It should make an assessment

of the important risk factors during the production process and control the process atthose points. The site should be in possession of the risk assessment of the design andshould record the process and outcomes of assessing the risk factors during production.

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In practice, the site may not be able to obtain this from its customer and, in this case,

should document the absence. It should still perform the risk assessment for in-process

hazards, as indicated in 5.2 Risk assessment of the manufacturing process.

When a site is assembling pre-fabricated components into a final product it must also

assure itself that a risk assessment has been carried out on the components, and that

the information is available to the factory and, at least as much as legally necessary, tothe purchaser.

Example

A site has been asked to produce children s cu tlery to match a supplied sample. The customer hasnot produced a risk assessment and the site does not have the auth ority to change the design orappearance of the product. The site documents the lack of a risk assessment, assures itself thatproduction meets the requirements of the prod uct standard for the region of sale and assesses theproduction risk s of sup ply or raw material s, possible contamination and con tro ll ing the mouldingprocess. It se ts con tro l po in ts on the setting s of the moulding machine and requires t he su pp ly ofraw materials to be accompanied by satisfactory test certificates.

The auditor would find this to be satisfactory. Any shortcomings in the design of the cutlery wouldbe the responsibility of the customer.

7.2 Product use

The following aspects of a products use should be considered.

7.2.1 Behaviour

The way in which a product is used will significantly influence the likelihood of injury.

Many injuries are caused when products are used in an inappropriate way, or when

people have not fully read or understood instructions. For childrens products, thisusually means that the items are given to children of an unsuitable age or that carers donot follow advice on the supervision of the child.

It is useful to define or consider what the intended use is and what reasonableforeseeable use may occur.

Examples

Yo-yo ball s are children s toys comprising a weigh ted ball w ith an in tegral cord made from highlystretchy plas tic material. The intended use is to bounce the product up an d down in a similar fashionto a yo-yo. In practice, children found that it was more fun to use the product l ike a lasso and therewere several near-strangulat ion incident s when the product became entangled around the neck.It i s dif ficu lt, in such cases, to decide whether th is wa s foreseeable bu t for anyone making similaritems in the future such a consideration would be important. This case also shows the need to keepup to date with changes and to be aware of product recall informa tion a s required by the Global

Standard. An auditor will look to see how this is achieved on site.A customer complains that there is a prob lem with their new ki tchen. The cooker extractor hood hasmelted and dripped onto the gas hob. The cooker hood is replaced but the problem recurs.It i s found that the cooker hood is o nly suitab le for use with elect rical ly powered hobs an d not

with gas hobs, which give out more heat. The information was available in the instructions for thehood but only in small text, mixed with other information. This was either not seen or disregarded.Sites must consider t he affect of their prod ucts on ot hers where relevant, and supply su itable

informatio n. If an auditor discovered a case such as this it would lead to a non-conformity as therisk had not been properly addressed.

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7.2.2 Durability

The frequency and duration of use may also affect the safety of a product. Sites shouldtry and establish the likely use of the product. This may be difficult when trying to

understand how a product is used in a culture very different from the one in which it ismanufactured.

Examples

A company in Southern China i s manufacturing sled ges for a retailer in Norway.The factory does not understand snow and is unaware of the frequency of use of a sledge byNorwegian families o r the roughnes s of the terrain. The sledge fai ls because the p last ic becomes

brittle at low temperatures and cannot with stand the forces applied over a period of time.Al though th is is unders tandab le, an d shows the d if ficu lty of m anufact ur ing p roducts tha t are notclearly understood, it would not be acceptable and would result in a non-conformity unless the

customer had been asked for a risk assessment and failed to provide one.

Electric blankets are assumed to have an in-use lifetime of three years. However, a market survey

show s that many blankets more than 10 years old are still in routine use. Unfortunately, the pla sticwiring sheath degrades over time and some of the blankets become an electrical/fire risk.If a p roduct is likely to become unsafe over time, a c lear ins tru ction to check the i tem or d ispo se o f

it may be required.

7.2.3 User awareness

An important part of the risk assessment process is deciding what level of awareness auser is likely to have about a hazard. Children do not generally exercise the same level

of thought and care when using products and may not consider the risks in the sameway as an adult. Older people may not see as clearly and not realise a hazard exists. If

the product is new and innovative, users may not have a clear idea of how to use it.

Examples

Cigarette lighters are widely used, without major problems, by adults throughout the world.

Recently there has been a trend towards n ovelty lig hters representing different objects such as guns,

sharks, fruit and figurines.These items are attractive to children who think of them as toys and do not understand the fire

risk. They have recently been ban ned in a number of count ries.

A customer receives a new set of cooking utensils. They are unaware that the new items do not

with stand heat as well as metal utensils and leave them near a flame on the stove top where theypresent a fire hazard.It i s foreseea ble that th is migh t ha ppen and so the company should cons ider prov id ing s ui table

warnings to alert the user.

7.2.4 Information and advice

Some products do have inherent risks that are accepted because of the perceived

benefits of the product. In some cases, it is possible to anticipate how the consumer may

react if an accident occurs and provide information to mitigate the results. The need forsuch measures, and how best to provide them, would be part of the risk assessment.

Example

A site is produc ing b leach. It sells the item in a bottl e with a child-proof openin g but it considersthat there is sti ll a small risk of someone ingesting the bleach.It has label led the bo tt le with ins tru ct ions on wha t to do i f someone does swal low the bleach andprovided an emergency help line. The bo ttle a lso has rai sed label ling in B rail le so visu al lyimpaired people know its contents.

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7.2.5 Cultural differences

Cultural differences may affect the way products are used, and this is a particularlyimportant consideration when dealing with the global marketplace. Manufacturers

sometimes try to innovate by introducing traditional products from one market to another,unfamiliar with their use. This can mean that products may be used in an unsafe way,unless the user is provided with more information than that which would be considered

necessary in the home market.

Example

Articulated pull-al ong metal carts for children are widely available in America, where generationshave grown up play ing wit h them and understan ding their use. These product s do not have brakes.When introduced to the European market, which is much less familiar with such products, therewas concern about the lack of braking as this was expected by purchasers.

7.3 Vulnerability of users

Users may be divided into intended and non-intended users. Particular attention should

be paid to the use of the product by vulnerable consumers.

Vulnerable consumers Definition

Young children Older than 36 months and younger than 8years

Older children 8 to 14 years

Vulnerable people People with reduced physical, sensory or

mental capabilities (e.g. partially disabled orelderly people with some reduction in theirphysical and mental capabilities). Those who

lack experience and knowledge (e.g. older

children)

Very vulnerable consumersVery young children 0 to 36 months

Very vulnerable people Persons having very extensive and severe

disabilities

It is not the purpose of the risk assessment to ensure that all products are safe and

suitable for all users. If this were the case, it would not be possible to sell many of theproducts that are in daily use such as motorcycles, sharp knives and weed killers.

However, it is important that consideration is given as to who the product is intended for

and whether anyone else is likely to use it. Products must be correctly presented to besuitable for the target market for example, bottles of weed killer must not be easily

mistaken for soft-drink containers. If products are not specifically designed for vulnerableusers then care must be taken not to present the items as appropriate.

Examples

Cookware can be decorated with characters from childrens TV series.This might encourage children to reach for hot pans and pull them over.

Packaging on the ou tside of an inflatable boat might show a small child alone in the boat.

The product itself may be safe and fit for purpose but it is not safe to leave a small child alone inthe boat.

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7.4 Hazards

The potential hazards of each product should be analysed. This may be done in a

number of ways, but it is generally advisable to take a systematic approach to the

possible hazards and the scenarios that are likely to produce injuries. Depending on theproduct type, and the amount of information a site has about the product range it makes,it will probably not be necessary to consider every aspect with every product. It is

necessary to consider aspects affected by changes in design, formulation orconstruction.

Examples

A factory o nly makes shampoo. It produces numerous different formulations for different customers.The products are all packed into plastic b ottl es of the same basic construction, but in different sizes.

Its customer wishes to introduce a new fragrance to one of the lines.There would be no need to consider physical injuries, flammability etc. as these would have beenpart o f a p revious assessm ent. The factory wou ld ju st need to co ns ider whe ther the chan ge has any

impact on chemical safety, or allergic reaction.

Sofas are produced in the same style and same basic construction but with a range of outer fabricchoices for upholst ery.There is no need to repeat the assessment of the sofa itself but the properties of the cover shouldbe reviewed with regard to flammability and chemical safety. Quality aspects may also need to beconsidered as these would affect the product being fit for purpose, and issues such ascolourfastness and abrasion resistance would also be relevant.

Table 1 lists some of the main hazard and injury types. This list can be used as a

template and customised to reflect the product types manufactured by a site. Sites may

also wish to add quality criteria. Quality matters do not present a health risk but can stillbe important as they may affect the fitness for purpose of the product or the producers

ability to meet its customers specification.

Table 1 Main hazard and injury types

Hazard group Hazard Typical injury scenario Typical injury Example

Size, shape and

surface

Sharp corner or

point

Person hits sharp corner or

is hit by moving sharpobject; this causes apuncture or penetration

injury

Puncture, blinding

foreign body in eye,hearing foreign bodyin ear

Darts

Table edges

Sharp edge Person touches sharpedge, this lacerates skin or

cuts through tissues

Laceration, cut,amputation

Broken glass or ceramicKnives

Burrs on metal edges

Gap or opening

between

elements

Person puts a limb or body

part in the opening and

finger, arm, neck, hand,body or clothing is trapped.

Injury occurs due to gravityor movement

Crushing, fracture,

amputation,

strangulation

Outdoor equipment with

potential traps such as

climbing framesChildren becoming trapped

between cot barsToes trapped in taps

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Potential energy:

problems fromproducts falling

or tipping

Low mechanical

stability

Product tips, person near

product is hit by theproduct; electrical producttips, breaks and gives

access to live parts, orcontinues to work heatingnearby surfaces

Bruising, dislocation,

sprain, fracture,crushing, electricshock, burn

TVs falling from wall

mountsUnstable wardrobesBadly weighted saucepans

Low mechanicalstrength

Product collapses byoverloading; electricalproduct tips, breaks andgives access to live parts,

or continues to workheating nearby surfaces

Bruising, dislocation,fracture, crushing,electric shock, burn

Chairs collapsingLadder rungs too weak

Pressurised

liquid or gas orvacuum

Liquid or gas under

pressure is suddenlyreleased, person in thevicinity is hit; or implosion

of the product producesflying objects

Dislocation, fracture,

crushing, cuts (seealso Fire andexplosion hazard)

Toy rockets

AerosolsSteam cleanersGas canisters

Kinetic energy:

problems frommoving productsor parts

Parts movingagainst one

another

Person puts a body partbetween the moving parts

while they move together,the body part gets trappedand put under pressure(crushed)

Bruising, dislocation,fracture, crushing

Power toolsFolding ironing boards

Door hinges

Noise energy Noise Person is exposed to noisefrom the product, tinnitus

and hearing l

brc cp guideline

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