ARO.GEN.220 Record-keeping

GENERAL

(a)The record-keeping system should ensure that all records are accessible whenever needed within a reasonable time. These records should be organised in a way that ensures traceability and retrievability throughout the required retention period.

(b)Records should be kept in paper form or in electronic format or a combination of both media. Records stored on microfilm or optical disc form are also acceptable. The records should remain legible and accessible throughout the required retention period. The retention period starts when the record has been created.

(c)Paper systems should use robust material, which can withstand normal handling and filing. Computer systems should have at least one backup system, which should be updated within 24 hours of any new entry. Computer systems should include safeguards against unauthorised alteration of data.

(d)All computer hardware used to ensure data backup should be stored in a different location from that containing the working data and in an environment that ensures they remain in good condition. When hardware or software changes take place, special care should be taken that all necessary data continue to be accessible at least through the full period specified in the relevant Subpart or by default in ARO.GEN.220(c).

AMC1 ARO.GEN.220(a)(1);(2);(3) Record-keeping

COMPETENT AUTHORITY MANAGEMENT SYSTEM Records related to the competent authority’s management system should include, as a minimum and as applicable:

(a)the documented policies and procedures;

(b)the personnel files of competent authority personnel, with supporting documents related to training and qualifications;

(c)the results of the competent authority’s internal audit and safety risk management processes, including audit findings and corrective actions; and

(d)the contract(s) established with qualified entities performing certification, authorisation or oversight tasks on behalf of the competent authority.

AMC1 ARO.GEN.220(a)(4);(4a) Record-keeping

ORGANISATIONS Records related to an organisation certified or operations authorised by or having declared its activity to the competent authority should include, as appropriate to the type of organisation:

(a)the application for an organisation approval, a specialised operation authorisation or the declaration received;

(b)the documentation based on which the approval or authorisation has been granted and any amendments to that documentation;

(c)the organisation approval certificate or specialised operation authorisation, including any changes;

(d)a copy of the continuing oversight programme listing the dates when audits are due and when such audits were carried out;

(e)continuing oversight records, including all audit and inspection records;

(f)copies of all relevant correspondence;

(g)details of any exemption and enforcement actions;

(h)any report from other competent authorities relating to the oversight of the organisation; and

(i)a copy of any other document approved by the competent authority.

ORGANISATIONS — DOCUMENTATION Documentation to be kept as records in support of the approval includes the management system documentation, including any technical manuals, such as the operations manual, and training manual, that have been submitted with the initial application, and any amendments to these documents.

AUTHORISATION HOLDERS — DOCUMENTATION Documentation to be kept as records in support of the authorisation of a high risk commercial specialised operation include the risk assessment documentation and related standard operating procedures (SOP), as well as a description of the management system of the proposed operation and a statement that all the documentation sent to the competent authority has been verified by the operator and found in compliance with the applicable requirements. Any amendments to these documents should be documented.

ACTIVITIES PERFORMED IN THE TERRITORY OF A MEMBER STATE BY PERSONS OR ORGANISATIONS ESTABLISHED OR RESIDING IN ANOTHER MEMBER STATE

(a)Records related to the oversight of activities performed in the territory of a Member State by persons or organisations established or residing in another Member State should include, as a minimum:

(1)oversight records, including all audit and inspection records and related correspondence;

(2)copies of all relevant correspondence to exchange information with other competent authorities relating to the oversight of such persons/organisations;

(3)details of any enforcement measures and penalties; and

(4)any report from other competent authorities relating to the oversight of these persons/organisations, including any notification of evidence showing non-compliance with the applicable requirements.

(b)Records should be kept by the competent authority having performed the audit or inspection and should be made available to other competent authorities at least in the following cases:

(1)serious incidents or accidents;

(2)findings through the oversight programme where organisations certified or authorised by another competent authority are involved, to determine the root cause;

(3)an organisation being certified, authorised or having approvals in several Member States.

(c)When records are requested by another competent authority, the reason for the request should be clearly stated.

(d)The records can be made available by sending a copy or by allowing access to them for consultation.

GENERAL Records are required to document results achieved or to provide evidence of activities performed. Records become factual when recorded. Therefore, they are not subject to version control. Even when a new record is produced covering the same issue, the previous record remains valid.