AMC1 21.A.139(d)(2)(ii) Production management system

VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT AND CONTROL — PRODUCTION ORGANISATION APPROVAL HOLDER THAT USES DOCUMENTED ARRANGEMENTS WITH OTHER PARTIES FOR THE ASSESSMENT AND SURVEILLANCE OF A SUPPLIER

(1) General

The production organisation is required by point 21.A.139(d) to demonstrate that it has established and maintains a quality system that enables the organisation to ensure that each item produced conforms to the applicable design data and is in a condition for safe operation. To discharge this responsibility, the quality system should have, among other requirements, procedures to adequately carry out the assessment and surveillance of suppliers.

The use of other parties (OPs), such as a consulting firm or quality assurance company, for supplier assessment and surveillance does not exempt the production organisation approval (POA) holder from its obligations under point 21.A.165. The supplier assessment and surveillance, corrective action and follow-up activity conducted at any of its supplier’s facilities may be performed by OPs.

The purpose of using an OP cannot be to replace the assessment, audit and control of the POA holder. It is to allow an element (i.e. the assessment of the quality system) to be delegated to another organisation under controlled conditions.

The use of OPs to perform supplier assessments and surveillance should be part of the production organisation quality system and fulfil the conditions of this AMC.

This AMC is applicable to a method whereby a POA holder has a documented arrangement with an OP for the purpose of assessing and/or surveying a POA’s supplier.

(2) Reserved

(3) Conditions and criteria for the use of OPs to perform supplier assessment and surveillance

(a) The POA holder should include the use of OPs for supplier assessment and surveillance in the POA holders’ quality system to demonstrate compliance with the applicable requirements of Part 21.

(b) The procedures that are required for using OPs for supplier assessment and surveillance should be consistent with other procedures of the POA holders’ quality system.

(c) The procedures of the POA holder that uses OPs to perform supplier assessment and surveillance should include the following:

(1) Identification of the OP that will conduct the supplier assessment and surveillance.

(2) A listing of suppliers under surveillance by the OP. This listing should be maintained by the POA holder and made available to the competent authority upon request.

(3) The method used by the POA holder to evaluate and monitor the OP. The method should include the following as a minimum:

(i) verification that standards and checklists used by the OP are acceptable for the applicable scope;

(ii) verification that the OP is appropriately qualified and has sufficient knowledge, experience, and training to perform its allocated tasks;

(iii) verification that the frequency with which the OP carry out surveillance of the suppliers is commensurate with the complexity of the product and with the surveillance frequency established by the POA holder’s suppliers control programme;

(iv) verification that the assessment and surveillance of the suppliers is including on-site surveillance activities that are conducted by the OP; and

(v) verification that the OP has access to the applicable proprietary data to the level of detail necessary to survey suppliers functions.

Where the POA holder uses an OP accredited by a signatory to the European cooperation for Accreditation (EA) Multilateral Agreement and works in accordance with an aviation standard (e.g. EN 9104 series of requirements) that describes requirements for the assessment and surveillance by the other party, items (ii) and (iv) shall be deemed to be complied with.

(4) A definition that states to what extend the OP will conduct surveillance of the suppliers on behalf of the POA holder. If the OP partly replaces surveillance by the POA holder, the POA holder should identify the functions that will continue to be surveyed by the POA holder.

(5) The procedures used by the OP to notify the POA holder of any non-conformity that is discovered at the supplier's facility, and of the corrective action and follow-up.

(d) The POA should make arrangements that allow the competent authority to make investigations in accordance with point 21.A.9 to include OP activities.