ASSESSMENT PROCESS FLOW CHART PREASSESSMENT ACTIVITIES DATA ASSESSMENT

ASSESSMENT PROCESS FLOW CHART PRE-ASSESSMENT ACTIVITIES DATA ASSESSMENT ON-SITE ASSESSMENT PROCESS ELECTRONIC DATA Determine Scope of Assessment Select Assessment Team Notify Laboratory & Request Records Conduct Pre -Assessment Records Review Plan On-Site Assessment Determine Team Assignments F Lack of documented assessment follow-up or corrective action F Questionable proficiency F Questionable technical depth F Recent, significant, organizational changes F F Lack of responsiveness Lack of management commitment to data integrity Data Transfer (from technical areas to reporting) On-Site Assessment Opening Meeting & Laboratory Tour RED FLAGS: PRE-ASSESSMENT RED FLAGS: OPENING MEETING & LAB TOUR F F Time wasters (e. g. lengthy health and safety overview, non-relevant briefings (e. g. history, sales) Selected staff not available for interviews F Housekeeping practices F Unexplained, restricted access Quality Systems and Management Assessment Quality Systems Documentation Organization and Functions Training Records RED FLAGS: QUALITY SYSTEMS AND MANAGEMENT ASSESSMENT F Lack of data integrity policy F Unclear communication of either expected behavior or improper practices F Lack of a “no-fault” reporting mechanism F Emphasis on production F Inadequate back-up (personnel and equipment) F Poor coordination for accepting new work Management Interviews Records Management & Archives Computer Access & Security (LIMS, Data Systems) Data Integrity Program (Records/ Policy) Corrective Action Sample Receipt and Storage Assessment SOPs Process Demonstration Sample Receipt and Storage Records Sample Custodian Interviews Technical Area Assessments SOPs Process Demonstration Logbooks, Bench Sheets, Maintenance Records Analyst Interviews RED FLAGS: SAMPLE RECEIPT & TECHNICAL AREA ASSESSMENTS Summary Reports HARD COPY DATA Case Narratives Archives - Original - Copies F Denials of access or conditional access F Attempts to distract the assessment team F Records not readily accessible F Discrepancies between method and SOP F Referenced methods out of date F Incomplete case narratives F Presence of pencils, white-out F Unexpected sample results F Extremely clean, neat logbooks F Too-perfect QC results F Uncontrolled records F Reports missing secondary reviewer signatures or dates F Logbook entries all aligned F F Discrepancies between SOP and practice Discrepancies between Co. C and reports F Expired standards F F Disabled audit trails Unexplained gaps/changes in records F Shared log-on and password access F Discrepancies in QC performance between analysts F Calibration records missing reviewer signature/dates RED FLAGS: DATA ASSESSMENT F Excessive overtime F “Bottleneck” departments F Lack of technical depth F High staff turnover F Unlabeled containers or illegible labels F Gaps in training records F Sample volume discrepancies F QA Staff lacks direct access to senior management F Materials inventory does not match throughput F “Reappearing” quality control results F Unclear roles and responsibilities F Sample throughput exceeds time required to process the samples F Screen-printed reports F F Managers translating or clarifying analysts’ responses to questions Routine dead time on autoinjection run logs F F Emphasis on production Samples or blanks diluted without apparent justification F Inadequate sample-handling procedures for evening or weekend deliveries F Too few quality control records to support data output F No mechanism for reporting problems F F Analysts not allowed to use their judgment Chronological chromatograms that do not display prevalent background F Analysts unable to describe data review and/or oversight F F Internal Audits Audit Trail QA staff performing competing functions Sample Storage Data Reduction and Review (Process) Glassware and Bottle Preparation Equipment and Facilities Inadequate internal assessments F Lack of data surveillance F Incomplete assessment files F Repeat assessment findings F Inadequate procedures for handling complaints F Corrective action fails to address root cause F Lack of timely follow-up or documentation of corrective action F Lack of record verification in archiving procedures F Inadequate procedures to ensure data retrieval Document Control Security Access and Computer Security Process Waste Disposal and Material Throughput