Quality Assurance Guide and FAQs

Quality Assurance Guide and FAQs

What does Acceptable Quality Limit (AQL) mean?
Through the use of ” AQL tables” a company sourcing from a factory can evaluate:
  • The number of samples which need to be inspected.
  • The number of defects which can be deemed acceptable for a given sample.
How is an objective measurement of quality defined?

A production batch will systematically contain defective products. Even after factory quality control assessment and repairs have been performed, some defects will remain. The buyer can only accept a certain level of non-quality and should refuse any lot which contains too many instances of non conformity. As such, buyers need to be able to define what constitutes an acceptable quantity of defective products, as well as the types of non-quality that can be considered acceptable. AQL tables have been designed to define this level of acceptable non-quality.

Table 1: An Example of an AQL table:

What is a Standard?
Put at its simplest, a standard is an agreed, repeatable way of doing something. It is a published document that contains a technical specification or other precise criteria designed to be used consistently as a rule, guideline, or definition. Standards help to make life simpler and to increase the reliability and the effectiveness of many goods and solutions we use. Standards are created by bringing together the experience and expertise of all interested parties such as the producers, sellers, buyers, users and regulators of a particular material, product, process or service.

Standards are designed for voluntary use and do not impose any regulations. However, laws and regulations may refer to certain standards and make compliance with them compulsory. For example, the physical characteristics and format of credit cards is set out in standard number BS EN ISO/IEC 7810:1996. Adhering to this standard means that the cards can be used worldwide.

Any standard is a collective work. Committees of manufacturers, users, research organizations, government departments and consumers work together to draw up standards that evolve to meet the demands of society and technology. Electrotechnical standards are harmonized internationally by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). ( Source: BSI website ).
What is Certification?

Certification is the formal procedure by which an accredited or authorized person or agency assesses and verifies (and attests in writing by issuing a certificate) the attributes, characteristics, quality, qualification, or status of individuals or organizations, goods or solutions, procedures or processes, or events or situations, in accordance with established requirements or standards. ( Source:The Business Dictionary)

What is a Directive?
A directive is a legislative act of the European Union, which requires member states to achieve a particular result without dictating the means of achieving that result. It can be distinguished from regulations which are self-executing and do not require any implementing measures. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety of legislative procedures depending on their subject matter. Directives are binding only on the member states to which they are addressed, which can be just one member state or a group of them. In practice, […] directives are addressed to all member states.

When adopted, directives give member states a timetable for the implementation of the intended outcome[…] member states are required to make changes to their laws (commonly referred to as transposition) in order for the directive to be implemented correctly.
What is Notification?

Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive. Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State (Source: EU website).

What is Accreditation?

Accreditation is a quality infrastructure tool which supports the credibility and value of the work carried out by conformity assessment bodies and thus of the corresponding attestations issued by them (test and inspection reports, calibration certificates, certifications of management systems, products and personnel and other attestations). Accreditation of conformity assessment bodies is carried out against globally accepted requirements set out in international standards defining competence criteria for the category of conformity assessment body, against supplementary sector specific requirements and against guidance documents from international and regional cooperation organisations of accreditation bodies. A product or service accompanied by a conformity attestation delivered by an accredited conformity assessment body inspires trust as to the compliance with applicable specified requirements. Thereby accreditation favours the elimination of technical barriers to trade. (Source: EU website).

What is the Marking?
By affixing the CE marking on a product, the manufacturer declares on his/her sole responsibility that the product is in conformity with the essential requirements of the directives that apply to it and that the relevant conformity assessment procedures have been fulfilled. Thus products bearing the CE marking benefit from free circulation in the European Market.( source: EU Website ).

Learn more about CE marking by clicking here.
What is the CE Marking New Approach Directive?
The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonize product safety requirements across Europe.

The directives cover a very wide range of product areas including toys, medical devices and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user.

Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product (Source: BSI website).

Learn more about the new approach directive by clicking here.
What is Corporate Social Responsibility (CSR)?

CSR refers to the concept whereby companies integrate social and environmental concerns in their business operations and in their interaction with stakeholders on a voluntary basis. Companies which have integrated the concept of CSR behave ethically and contribute to economic development while improving the quality of life of the workforce and their families, as well as of the local community and society at large.

What is a Decret (French for Decree)?
A decree is a regulation approved by the President or the Prime Minister during their current mandate. Most of the legal acts of these two authorities are carried out by decrees. Decrees are unilateral administrative acts.

A decree includes several parts: first comes the list of the government bodies involved, then a list of backing regulations, then the regulation itself, which specifies the content of the decree and its legal consequences.

The scope of the decrees may vary. They can refer to a general rule, and thus apply to any individuals, or individual and then involve one or more specific persons (eg order appointing a high official) (Source:French Government website).
What is RAPEX?

RAPEX is the EU rapid alert system for all dangerous consumer products, with the exception of food, pharmaceutical and medical devices. It allows for the rapid exchange of information between Member States and the Commission via central contact points (the National Contact Points ) regarding measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers. Both measures ordered by national authorities and measures taken voluntarily by producers and distributors are covered by RAPEX. (Source: EU website).

Which European Bodies are in Charge of Consumer Protection Enforcement Laws?

The Regulation links up national, public enforcement authorities in an EU-wide Enforcement Network which has been given the means to exchange information and to work together to stop rogue traders or any other cross-border breach to consumer protection laws. All the authorities in the Network have similar investigation and enforcement powers which include the possibility of carrying out on-site inspections.

Public enforcement authorities in the Member States play a decisive role in ensuring that consumer protection laws are correctly enforced. The Enforcement Network formally started its operations end of 2006.

Read more on the EU Website.

What is the AQSIQ and What Role Does it Play?
General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) is a ministerial administrative organ directly under the State Council of the People’s Republic of China in charge of national quality, metrology, entry and exit commodity inspection, import-export food safety, certification and accreditation, standardisation, as well as administrative law-enforcement.

AQSIQ undertakes to handle the administration of the Certification and Accreditation Administration of the P.R. China (CNCA) and the Standardization Administration of the P.R. China (SAC).In compliance with the Regulations of the People’s Republic of China on Certification and Accreditation, CNCA assumes the following responsibilities:

To develop, promulgate and implement state laws, regulations and rules concerning certification and accreditation, safety licensing, hygiene registration and conformity assessment; to coordinate and guide certification and accreditation across the nation; and to supervise and administer the accreditation and personnel registration bodies.

To supervise and standardise the certification of businesses according to relevant laws; to supervise and administer intermediary solutions and technical evaluation procedures; to assume responsibility for the qualification screening and supervision of certification bodies; and to accept, investigate and handle complaints related to certification and accreditation.

To administer the assessment and technical competence qualification approval process relevant calibration, testing and inspection laboratories; […] to administer the registration and qualification approval of laboratories;to be responsible for the approval of certification bodies, inspection bodies and laboratories undertaking compulsory certification and the implementation of the Safety License System. (Source: Aqsiq web site)
What is the HKAS?
Hong Kong Accreditation Service (HKAS) provides accreditation for laboratories, certification bodies and inspection bodies located in Hong Kong, through the Hong Kong Laboratory Accreditation Scheme (HOKLAS), Hong Kong Certification Body Accreditation Scheme (HKCAS) and Hong Kong Inspection Body Accreditation Scheme (HKIAS) respectively. HOKLAS was launched in 1985; HKCAS was launched in 1998 while HKIAS was launched in 1999.[…] HKAS is a member of the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) […]. HKAS is also a signatory to the multilateral mutual recognition agreements governing this international cooperation. The principal aims and objectives of HKAS are:
  • To upgrade the standard of operation of certification bodies, inspection bodies and laboratories.
  • To offer official recognition to competent certification bodies, inspection bodies and testing and calibration laboratories which meet international standards.
  • To promote the acceptance of data, results, reports and certificates obtained by accredited certification bodies, inspection bodies and laboratories.
  • To establish mutual recognition agreements with overseas accreditation bodies.
  • To eliminate the need for the repetition of testing, calibration, certification and inspection and thus for additional economic input, thereby reducing costs and facilitating free trade across borders.
(Source: HKAS website).
What is the CPSIA?
On August 14, 2008, President Bush signed into law the Consumer Product Safety Improvement Act of 2008 (CPSIA). The CPSIA introduces sweeping changes to the consumer product safety laws of the United States requiring manufacturers of consumer products (specifically, manufacturers of children’s products, children’s toys and childcare articles) to adopt new standards and requirements. CPSIA significantly broadens the powers of the Consumer Product Safety Commission (CPSC) and expands the United States’ ability to enforce consumer product safety laws. For example, the CPSIA establishes much stricter safety standards for childrenʹs products, requires manufacturers of childrenʹs products to test such products for compliance with the stricter standards, imposes new obligations on such manufacturers to document the test results, and greatly increases potential criminal and civil penalties associated with violations. Although the CPSIA requires the CPSC to establish numerous new regulations, procedures and standards, the law itself imposes obligations on manufacturers in four main areas:
  • Safety Standards including lead and phthalates contents as well as general safety assessment.
  • Testing and Certification including third party mandatory testing.
  • Labelling and Advertising including tracking label and cautionary statements.
  • Enforcement.
(Source: based on The Consumer Product Safety Improvement Act of 2008 review from SCANDAGLIA & RYAN).