OMB Winter Mtg.-February 5-6, 2015

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Draft 6. Note: This document is a draft suggestion only and is not an approved document. Please do not distribute to laboratory staff for use. 4.1.5 Conflict-of-interest agreements shall be established along with appropriate training programs for personnel. On a pre-determined schedule, all affected staff members shall attest that they understand the conflict-of-interest agreement and shall adhere to the requirements. There shall be readily available to staff members an organizational description that could include an organizational chart or charts indicating all reporting relationships and responsibilities. The organizational description shall include the most responsible position at each level of that hierarchy. 4.1.6 Note : Examples of communication processes are regularly scheduled meetings, distributing the annual management review to laboratory staff, effective leadership and supervision, etc. 4.2 Management System 4.2.1 The management systems can be incorporated into a quality manual for a multifunctional laboratory, but specific sections pertaining to special needs for various analytes and/or techniques shall be easily identifiable. There may be specific subsections for various analytes included in the document. 4.6 Purchasing Services and Supplies 4.6.2 In some industries, such as dietary supplement or pharmaceutical, the use of specific reference materials is mandated by the authoritative body, for example, the USP Reference Standards or the EP Certified Reference Standards. Reference Materials/Standards obtained from such authoritative sources are presumed to be suitable for their defined uses. The laboratory shall ensure that the quality of the reagents used is appropriate for the tests concerned. 4.6.4 Once a supplier has been evaluated and approved there shall be a program to ensure continued suitability of the supplier. 4.8 Complaints For dietary supplements and pharmaceuticals, a qualified person must review complaints for possible failures and investigate where needed. 4.9 Control of Nonconforming Testing and/or Calibration Work Note : Specifications may be an important aspect of the laboratory’s samples, therefore procedures for responding to out of specification (OOS) results should be considered. The degree to which OOS results are investigated can vary, so the laboratory is encouraged to design procedures that suit the industries they serve. Guidelines are available from organizations such as FDA and TGA. 4.13 Control of Records 4.13.1 General 4.13.1.1 The laboratory shall specify a minimum acceptable level of record maintenance and security. The maintenance and security of all records shall be consistent with customer requirements. 4.13.1.2 Record retention policies shall be consistent with customer requirements and the requirements of the laboratory. 4.13.2 Technical Records