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AMC1 21.A.5 (d) & (e) Record-keeping

ED Decision 2022/021/R

RECORD OF STAFF INVOLVED IN DESIGN OR PRODUCTION

(a) The following should be the minimum information to be recorded for each person that exercises the privileges of an organisation that is approved according to Part 21, Subparts G and J, or according to points 21.A.163 or 21.A.263, or that carries out the independent monitoring of compliance and adequacy according to points 21.A.139(e) and 21.A.239(e), or that carries out the independent verification function of demonstration of compliance pursuant to point 21.A.239(d)(2):

(a) name;

(b) date of birth;

(c) basic training received and standard attained;

(d) specific training received and standard attained;

(e) continuation training received (if appropriate);

(f) experience gained;

(g) scope of the authorisation;

(h) date of first issue of the authorisation;

(i) expiry date of the authorisation (if appropriate;

(j) identification number of the authorisation (or equivalent means to identify the link between the authorisation and the staff member that holds the authorisation); and

(k) changes to the data.

(b) The record may be kept in any format and should be controlled through an internal procedure of the organisation. That procedure is part of the management system.

(c) The staff member should be given reasonable access, on request, to their own records as per Regulation (EU) 2016/679.

(d) A design organisation (DO) or production organisation (PO) should keep the record for at least 3 years after the staff member is no longer employed by the organisation or has changed their position in the organisation, or after the withdrawal of the authorisation, whichever occurs sooner.

(e) Records of authorisation of the production staff are to be archived for at least 3 years after the staff member is no longer employed by the organisation or as soon as the authorisation is withdrawn. This staff member is any person that has an activity that is essential for ensuring:

— the conformity to applicable design data, or

— a condition for the safe operation of a product, part, or appliance.