GM No 3 to 21.B.220(c) Procedures for investigation – POA applications received from organisations with facilities/partners/ suppliers/sub-contractors located in a third country    

The obligations of the applicant are totally independent from the surveillance exercised by the CAA. It is not acceptable that the applicant relies on surveillance activities of the CAA to simplify its tasks.

Facilities located in a third country

When any part of the production facilities of an applicant for POA is located outside the United Kingdom, then the location will be treated in all aspects as part of the applicant’s POA organisation.

Therefore the investigating CAA will:

a) include the facilities outside the United Kingdom fully in their investigation and surveillance activities for the applicant for, or holder of, the POA

b) include the facilities outside the United Kingdom in the terms of approval of the CAA Form 55 (see Annex I Part 21 Appendix X) when issuing the POA.

Partners/suppliers/sub-contractors located in a third country

The CAA should define on the basis of Part 21, its associated CS and GM, a clear procedure on supplier control. This procedure should include the control of partners/suppliers/sub- contractors of the applicant for, or holder of, a POA that are located outside the United Kingdom.

In respect of the applicant for, or holder, of the POA, the CAA should:

1) investigate, for the initial approval and consequent continued surveillance, the production organisation, and its partners/suppliers/sub-contractors at the necessary level to ensure the organisation can comply with the requirements of Part 21,

2) in accordance with the CAA procedure, assess and accept the documented procedure for supplier control as part of the POA holder’s quality system, and changes to that procedure prior to implementation,

3) in accordance with CAA procedure, assess the necessary level of surveillance to be exercised by the production organisation on partners / suppliers / sub-contractors and check the audit plan of the production organisation against this level.

The level of co-operation between the CAA and the CAA of the third country where a partner/supplier/sub-contractor of the production organisation is located may influence the authorities’ activities concerning this partner/supplier/sub-contractor. Co-operation with the CAA of the third country should be based on the capability and goodwill of that authority, and a complete interchange of necessary information.

The involvement of this CAA of the third country in the surveillance of the partner/supplier/sub-contractor will be based on the following principles:

— When a recognition agreement under Article 12 of Regulation (EC) No 216/2008 covering production subjects has been concluded:

a) The CAA in accordance with GM No 2 to 21.A.139(a) may decide that direct surveillance of the POA holder activities at the foreign location may not be necessary.

b) In any other case, provisions of the recognition agreement on the subject apply (technical assistance, ...).

— If a recognition agreement has not been concluded, or it does not cover production subjects, it may be necessary that the CAA and the CAA of a third country enter into a specific working arrangement addressing the following matters:

a) acceptance by the CAA of the third country of conducting manufacturing surveillance of the relevant production activities on behalf of the CAA, under the respective quality standards defined by the CAA.

b) tasks to be performed

c) practical methods

These arrangements are between authorities and do not relieve the applicant of its obligations.

— In all cases, even though surveillance tasks are delegated to the CAA of the third country, the CAA remains the responsible authority and may consequently exercise direct surveillance if necessary.

— In case that it is not possible to delegate surveillance tasks to the CAA of the third country, the CAA will have to establish a direct surveillance program in accordance with its procedure concerning supplier control as part of the overall surveillance of the POA holder.