Description of Business Function
The function of converting raw materials, components, or parts into finished goods.
Basis of Retention and Disposition
All CE marking directives require the manufacturer of the product to create a technical file which should contain the information required to show that the product properly complies with the requirements of the directives which apply to it. Various UK Regulations have been enacted to implement the directives. Typically the file must be kept for 10 years or 15 years for an Annex IV category of machine within the Directive.
NB The initials “CE” do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Directive(s).
However, it is likely that all design data and specifications would be held for the life of the company or longer for intellectual property right and potentially heritage reasons.
There is also the need to keep Sourcing and Supply Chain records on the basis of the 10 year limitation of legal action for product liability under Consumer Protection Act 1987, c 43, Schedule I, Part I, 11A (3).
Please also see the General Business category of the wiki.
Retention Rules Per Record Type
It is likely that all design data and specifications would be held for the life of the company or longer for intellectual property right and potentially heritage reasons.
All new machinery in scope of the Machinery Directive has to be designed and constructed to meet common minimum European requirements for safety. These requirements have been implemented in the UK by the Supply of Machinery (Safety) Regulations 2008, as amended by the Supply of Machinery (Safety) (Amendment) Regulations 2011. In addition to machinery these requirements also apply to interchangeable equipment, safety components placed independently on the market, lifting accessories, chains, ropes and webbing, removable transmission devices and partly completed machinery.
As part of this a technical file is compiled to demonstrate compliance with the above processes and requirements. This must be kept securely for at least 10 years from the last dates of manufacture and be made available on request to market surveillance authorities. This is 15 years for an Annex IV category of machine within the Directive.
The following are some, but not all, of the record retention requirements within The Supply of Machinery (Safety) Regulations 2008:
PART 2Annex II: Declarations, s. 2. CUSTODY states: “The manufacturer of machinery or the manufacturer’s authorised representative shall keep the original EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery. The manufacturer of partly completed machinery or the manufacturer’s authorised representative shall keep the original declaration of incorporation for a period of at least 10 years from the last date of manufacture of the partly completed machinery.”
PART 7 Annex VII: Technical files, A. Technical file for machinery, s. 2 states: “The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other EEA state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.”
PART 7 Annex VII: Technical files, B. Relevant technical documentation for partly completed machinery states: “The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other EEA state.”
This is aligned to retention requirements in other legislation such as:
- The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 1996
- The Lifts Regulations 1997
- The Electrical Equipment (Safety) Regulations 1994
- The Pressure Equipment Regulations 1999
- The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000
- Registration, Evaluation, Authorisation & restriction of CHemicals (REACH)
For Annex IV type of machinery, PART 9 Annex IX: EC type-examination, s. 4 – “If the type satisfies the provisions of the Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and the manufacturer’s authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject. The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate.”
and s. 9.3 – “The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years. If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years. The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate.”
There is the need to keep records identifying the source of every item supplied for evidence in potential defence of claim by individual who suffers damage as a result of a defective product; ability to bring action within 10 years under Consumer Protection Act 1987, c 43, Schedule I, Part I, 11A (3) – a typical retention period would be 11 years.
Citations and References
The Machinery Directive 2006/42/EC http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:157:0024:0086:EN:PDF
The Supply of Machinery (Safety) Regulations 2008 http://www.legislation.gov.uk/uksi/2008/1597/made
UK Government Guidance on CE Marking https://www.gov.uk/ce-marking
Consumer Protection Act 1987, c 43, Schedule I, Part I, 11A (3), Actions in respect of defective products, “(3)An action to which this section applies shall not be brought after the expiration of the period of ten years from the relevant time, within the meaning of section 4 of the said Act of 1987; and this subsection shall operate to extinguish a right of action and shall do so whether or not that right of action had accrued, or time under the following provisions of this Act had begun to run, at the end of the said period of ten years.”
The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 1996 http://www.legislation.gov.uk/uksi/1996/192/made
The Lifts Regulations 1997 http://www.legislation.gov.uk/uksi/1997/831/made
The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 as amended http://www.legislation.gov.uk/uksi/2000/730/made
The Pressure Equipment Regulations 1999 http://www.legislation.gov.uk/uksi/1999/2001/made
The Electrical Equipment (Safety) Regulations 1994 http://www.legislation.gov.uk/uksi/1994/3260/made
Registration, Evaluation, Authorisation & restriction of CHemicals (REACH), EU Unofficial consolidation of the REACH Regulation and Directive legal text, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006R1907-20130701&rid=2