A few years ago a machinery manufacturer in Michigan asked for help in CE Marking two stand-alone machines and an assembly line of six machines in which the two stand alone machines would be two of the assembly line components. The Assembly Line was for a fuel injection system destined for a new GM plant in Portugal. Therefore, we had to CE Mark the two machines and separately CE Mark the assembly line. The mayor of the town in Portugal was so happy with the new plant he tried to assure both GM and the machinery manufacturer that he wouldn’t require a CE Mark, but it was never his choice, it was EU law.
The two stand-alone machines were relatively direct and straight-forward, each requiring an Annex I Checklist, EN harmonized standards to demonstrate conformity with the essential requirements including the EN 1050 Risk Assessment Standard, Technical File, EC Declaration of Conformity and compliance with the requirements of the Low Voltage and EMC Directives.
The Assembly Line CE Mark was a bit more complex. After looking at companies that manufactured the other four components we had a bit of luck in finding a CE Marked machine for each component. Attention then turned to CE Marking the Assembly Line comprised of the six machines and the conveyor system that carried the fuel injection system through each stage of its manufacture and assembly to the finished system. We again constructed a Checklist, list of EN standards including EN 1050 Risk Assessment Standard, Technical File, EC Declaration of Conformity and compliance with the Low Voltage and EMC Directives.
A critical element in the documentation was to describe each of these steps in clear English so that the design decisions and risk assessment decisions were clear and could be understood in the future by GM, EU officials and EU & US Courts of Law in case of a legal challenge.
As noted in an earlier blog on document control, “If you can’t prove it, it doesn’t exist!” This means that the design records, contract records, process control records and post sale-records must exist in order to prove that your company performed as claimed. This should be accounted for in a company’s records management program. The EU Product liability Directive adopted in 1985, states in Article 6:
1. A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including:
(a) the presentation of the product;
(b) the use to which it could reasonably be expected that the product would be put;
(c) the time when the product was put into circulation.
In Article 11 it states:
1. Member states shall provide in their legislation that the rights conferred upon the
injured person pursuant to this directive shall be extinguished upon the expiry of a
period of 10 years from the date on which the producer put into circulation the actual
product which caused the damage, unless the injured person has in the meantime
instituted proceedings against the producer.
In sum, this means that the manufacturer of the product for the EU must keep critical records for at least 10 years. In the US records should be kept far longer. In some cases, depending on the product, this could mean 20 – 50 years. “If you can’t prove it, it doesn’t exist!”
The fact that some quality managers want to eliminate quality records earlier is irrelevant. Records should be divided into those records that can be disposed of on a timely basis and those records that are needed to defend a company in the event of a product liability lawsuit.
If you have product liability and risk assessment concerns concerning the Machinery Safety Directive and related Directives, you can contact me for a free preliminary consultation at email@example.com