Laboratory Management Structure and Position Requirements

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1.0 Purpose 
 
 This procedure establishes a process that ensures laboratory information regarding the
 relationships and interrelation of responsibilities performed by managerial, technical, and
 support personnel will be structured to perform and verity work affecting the results of the
 
 2. Seope 
 
 This procedure applies to all laboratory personnel and laboratory managerial, technical, and
 support personnel, 
 
 3. Responsibility 
 
 a Sui ft is the responsibility of Management to ensure laboratory information regarding the
 
 relationships and interrelation of responsibilities performed by managerial, technical,
 and Support personnel will be structured to perform and verify work affecting the
 results of the laboratary’s activities. 
 
 4.0 References 
 
 4.40 A-LU3 SOP, Training Procedure 
 
 42 A-T17, SOP, Personnel Qualifications 
 
 Si} Procedure 
 
 ).1 Management Structure and Position Requirements 
 
 “11 Dates, responsibilities, authorities, required qualifications and education,
 technical knowledge, skill, training, and experience f&or functions that ailect the
 
 Descriptions and Training Records, reference S§‘ OP Al i32 ‘Training Procedure
 
 and SOP A-117 Personnel Qualifications, 
 
 len ‘12 The information below regarding the relationshi ps and interrelation of
 
 
 

[SOP D-120 | Page 2 of 5]

 Standard Operating Procedure SOP oo | me 
 
 L- aboratery M3 a‘ nage, mentL Sxt ruct. ure and Posi h t ee i n on D = E Z } G P P, a ge 2 4 of P 5 i ‘
 Requirements | | ; | 
 
 responsibilities performed by managerial, technical, and support laboratory
 
 personnel will be structured to perform and verily work affecting the results of
 the laboratery’s activitioe 
 
 The duties, responsibilit*ies, and authorities associated with the information )4
 ° 
 ye saL 
 below, along with the roles, responsibilities and authorities described in the
 process procedures, is communicated ta assigned personnel during orientation
 activities, on-the-job training, and during mteractions between Management and
 supervisory staff during routine meetings and/or performance evaluations.
 S14 The organization and management structure of lon Labs Laboratory is controlled
 by fon Labs Oreanization chari. The positions listed are the personnel who
 
 manage, perform, and verify work affecting the results of the Lab’s activities or
 support the Laboratory in some manner through their assiened work. Some of
 the specific responsibilities, authorities, and interrelationship of personnel is
 
 A. Director of Quality-General Duties, Responsibilities and Authority th raf
 
 S151 The Director ofQuality is responsible for the overall managernent of
 
 jon LabsLaboratory. Thetr management responsibilities include
 supervision of stall as well as to provide oversight of testing, financial
 ree] 
 administration, and hirmg. 
 S82 The Direcior ofQuality to ensure use of good laboratory practices,
 inching maimtaiming client relationships. 
 
 3.4.5.3 The Director of Quality works with Sales personnel to oversee the
 rnanagesnent of customer satisfaction and customer requirements
 
 aL sS sS Yhe Cnrectar of Qualityhas responsibility for overseeing the quality,
 canformance, and effectiveness of the Laboratory Management
 
 System. The Director of Quality oversees laboratory activities and
 related results to identify deviations from the methods for performing
 tests, evaluates the significance of the deviations, and initiates actions
 to prevent or nuininize any deviations of the laboratory management
 
 system or the methods for performing tests to ensure the laboratory
 achieves Intended outcomes. The Director of Quality has primary
 responsibility for ensuring the effectiveness of laboratory activities,
 
 S1S.5 The DNrector of Onality oversees all aspects of the laboratory
 
 
 

[SOP D-120 | Page 3 of 5]

 SOPNo | Rev | 
 Standard Operating Procedure 
 Laboratory Management Structure and Position D120 § | Page3 of 5 
 Requirements 
 
 RAC 
 
 da 
 
 ero 
 management systern (LMS), including compliance with the
 requirements of ISQ 17025. The Director of Quality is responsibfioer
 and has the authority for implementation, maintenance, identification.
 of deviations aad inyprovement of the LMS. The Director of Quahty
 the Ms, and any need for improvements, including imitiation of
 actions To i vn or minimize amy deviations of the LMS or the
 procedures for performing laboratory activities. 
 The Director of Quality maintains the Laboratory System Management
 Manual and oversees and documents trainmg of fon Labs on the
 laboratory processes and procedures. This includes laboratory
 management system development, maintenance and infegrity, and
 guarding impartiality in all tests. 
 The Director of Quality initiates and executes (or oversees} mternal
 andus, monitors improvernent actions and corrective actions, and
 supports external assessors of the Asoreditation Body. Vhe UNrector of
 Quality works to ensure continuous improvement ofthe LMS.
 5.8 OC Lab Manager -General Duties,Responsibweilities and Authority
 The QC Lab Manager has responsibility for managing the daily
 operations of the Laboratory. The OC Lab Manager oversees
 laboratory activities and related results to identify deviations from the
 deviations, and initiates actions to prevent or tninimize any, deviations
 of the laboratory management sysiem or the methods for performing
 fests to ensure the laboratory achieves intended outcomes.
 The QC Lab Manager is authorized to perform all laboratory activities,
 including but sot limited to the development. modifications,
 staiements of conformity or opinions and interpretations; and report,
 review, and authorization of results, The QC Lab Manager is
 responsible for training Laboratory personnel supervising Laboratory
 personnel and monitoring their competence 
 The QC Lab Manager performs training of IonLabs Laboratory
 personnel on Laboratory and test processes and procedures, This
 includes maintenance and integrity and guarding impartiality in all
 jests. The OC Lab Manager also works to ensure continuous
 

[SOP D-120 | Page 4 of 3]

 Standard Operating Procedure SOP No | Rev 
 tion D128 Page 4 of 3 | 
 Laboratory Management Structure and Positie 
 Requirements ce 
 
 unprovemont of the Laboratory processes. 
 
 $.1.5.12 The QC Lab Manager is also responsible for reporting to the Director
 
 of Quality on the performance ofthe LMS and any need for
 improvements, including initiation of actions fo prevent ar minimize
 any deviations of the LMS or the procedures for performing laboratory
 
 5.1.6 OC Supervisor - General Daties, Responsiiilities and Authority
 
 5.1.6.1 “Phe QC Supervisor isauthorized to perform all laboratory activities,
 including but not limited to the development, modifications,
 t 
 verification, and validation of methods. 
 haL 16.2 The QC Supervisor performs trauung of ion Labs laboratory personnel
 
 5.1.6.3 The OC Supervisor also works to ensure continuous improvement of
 the Laboratory processes. 
 
 ys 1.6.4 The QC Supervisor provides input te the QC Lab Manager who
 oversees laboratory activities and related results to identify deviations
 from the methods for performing tests, evaluates the significance of the
 
 deviations, and initiates actions to prevent or minimize any deviations
 of the laboratory management system or the methods for performing
 tests to ensure the laboratory achieves intended outcomes.
 
 2.10.3 The OC Supervisor is suthorized to act as a backup for the QC Lab
 Manager with regards to maintaining and updating documents and
 
 records, objectively judging laboratory operations and their
 
 3.7 Laboratory Analysts -General [yaties, Responsibilities and Authority
 
 SUF. The Laboratory Analysts has responsibility for performing test
 activities, interacting with customers, an¢d performing activitics i
 
 items and performing maintenance on equipment, 
 
 S172 The Laboratory Analysts is authorized te perform laboratory activities,
 inclading but not lnmited ta analysis of results, including statements of
 conformity or opimions and interpretations, and repori, review, and
 
 authorization of resalits, 
 
 

[SOP D-120 | Page 5 of 5]

 Standard Operating Procedure SOP No Rey 
 Laboratory Management Structure and Positi*on Page 5 of S 
 Requirements 
 
 yS‘ The Laboratory Analysts is authorized te audit on the technical aspects
 
 of the Lab’s activities related to the accreditation and tests in general.
 
 YH ameS ds yA 
 methods for performing tesis, evaluates the significance of the
 deviations, and initiates actions fo prevent or minimize any devistians
 of the laboratory management system or the methods for performing
 
 tests to ensure the laboratory achieves intended oulcames.
 
 The Laboratory Analysts is authorized to make recommendations to
 the OC Lab Manager for updates and enhancernents to the LMS and
 recommends approval of correction actions to the OC Lab Manager.
 
 0 10/30/21 
 { 2 20-0026