<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".10" citation="COMAR 10.51.06.10" title_num="10" subtitle_num="51" chapter_num="06" heading="Quality Assurance Manager — Duties and Responsibilities.">
  <paragraph num="A.">
    <text>Under the authority of the director, and operating independently of casework, a quality assurance manager shall be responsible for:</text>
    <paragraph num="(1)">
      <text>Establishing:</text>
      <paragraph num="(a)">
        <text>A comprehensive quality assessment system that includes quality control and quality assessment programs that cover the forensic analyses performed; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Parameters for necessary levels of performance for forensic analyses;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The overall maintenance and operation of the laboratory’s quality assurance program; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Maintaining pertinent documentation and records of quality assurance activities.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The quality assurance manager shall:</text>
    <paragraph num="(1)">
      <text>Oversee the:</text>
      <paragraph num="(a)">
        <text>Participation and usage of an approved proficiency test provider commensurate with the licensed forensic analysis services;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Administration of proficiency testing; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Evaluation of proficiency test results;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Maintain the forensic laboratory’s quality assurance:</text>
      <paragraph num="(a)">
        <text>Program; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Program manual;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Evaluate instrument records for:</text>
      <paragraph num="(a)">
        <text>Calibration;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Validation; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Maintenance;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Review:</text>
      <paragraph num="(a)">
        <text>Standard operating procedures;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Internal audit records;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Training records;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Competency records;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Proficiency tests;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Management reviews; and</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Quality assurance documentation;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Ensure all methods, including new methods and modifications to current methods, are validated;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Select, train, and evaluate internal auditors;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Investigate technical problems;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Propose corrective or remedial actions;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Verify that corrective or remedial actions:</text>
      <paragraph num="(a)">
        <text>Are implemented; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Correct the identified problem;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(10)">
      <text>Assess the adequacy of record review activities, including but not limited to:</text>
      <paragraph num="(a)">
        <text>Reports; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Case records;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(11)">
      <text>Document all corrective actions taken when forensic analysis systems and procedures deviate from the forensic laboratory’s established performance specifications; and</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Maintain records that demonstrate that proficiency testing samples are analyzed in the same manner as any other evidentiary specimen or sample received by the forensic laboratory for forensic analysis.</text>
    </paragraph>
  </paragraph>
</regulation>