Corrective action 1.2.17 Signature/initials of individual responsible? 1.2.18 Are control data organized and presented so they 1.2.19 can be evaluated daily by technical staff to detect problems, trends, etc.? Is lot number change of quality control material 1.2.20 documented on the quality control record? Are quality control records retained for at 1.2.21 two years? Are quality control statistics (ie. SD and CV) 1.2.22 calculated at specified intervals to define analytical imprecision? Procedure Manual 2.0 Is a current procedure manual available for 2.1 laboratory staff? Is the procedure manual maintained as per the 2.2 documented procedure? Are the following included for each procedure: 2.3 (if applicable) Purpose 2.3.1 Specimens (type, source, amount, storage) 2.3.2 Equipment and Materials required 2.3.3 Preparation and storage of reagents, standards 2.3.4 and controls Procedure including Step by step instructions 2.3.5 – Directions for calibration 2.3.6 Derivation of results (ie. mathematical 2.3.7 calculations, dilutions) Quality control 2.3.8 Linearity limits 2.3.9 Precision 2.3.10 Reference ranges 2.3.11 Clinical Significance 2.3.12 Critical values 2.3.13 Reporting results (units, stats, critical values) 2.3.14 Safety 2.3.15 Is there documentation of annual review of the 2.4 procedure manual by the laboratory director or designate? Is documentation of annual review of the 2.5 procedure manual by the laboratory staff?
1.2.17 Corrective action 1.2.18 Signature/initials of individual responsible? 1.2.19 Are control data organized and presented so they can be evaluated daily by technical staff to detect problems, trends, etc.? 1.2.20 Is lot number change of quality control material documented on the quality control record? 1.2.21 Are quality control records retained for at two years? 1.2.22 Are quality control statistics (ie. SD and CV) calculated at specified intervals to define analytical imprecision? 2.0 Procedure Manual 2.1 Is a current procedure manual available for laboratory staff? 2.2 Is the procedure manual maintained as per the documented procedure? 2.3 Are the following included for each procedure: (if applicable) 2.3.1 Purpose 2.3.2 Specimens (type, source, amount, storage) 2.3.3 Equipment and Materials required 2.3.4 Preparation and storage of reagents, standards and controls 2.3.5 Procedure – including Step by step instructions 2.3.6 Directions for calibration 2.3.7 Derivation of results (ie. mathematical calculations, dilutions) 2.3.8 Quality control 2.3.9 Linearity limits 2.3.10 Precision 2.3.11 Reference ranges 2.3.12 Clinical Significance 2.3.13 Critical values 2.3.14 Reporting results (units, stats, critical values) 2.3.15 Safety 2.4 Is there documentation of annual review of the procedure manual by the laboratory director or designate? 2.5 Is documentation of annual review of the procedure manual by the laboratory staff?
CRA-F-05-15189-S-04-Molecular%20Diagnostics%20Inspection%20Checklist.docx