Physical Evidence Section Southwestern Institute of Forensic Sciences

Validation Plan
Submitting Unit: Validation Title: Prepared by: 1. Type of validation (check the applicable box): Equipment Modification of an existing protocol New protocol 2. Is this an original or revised validation plan? Original Revised 3. Describe briefly the analytical need that will be met by the validated equipment/procedure: 4. Attach the written procedure (check the applicable box): For equipment validation - the existing procedure that uses the instrument For modification of an existing procedure - the existing procedure and the modified procedure to be validated For a new procedure - the new procedure to be validated 5. Validation plan: Briefly describe the planned experiments/studies that will be conducted to address the following validation objectives. If a particular objective is not applicable, indicate this by N/A. a. Satisfaction of identified analytical needs and current scientific practices: b. Comparison to existing methods/instrumentation: c. Range of acceptable conditions for valid results/performance: d. Sources of method/instrument error:
PES Validation Plan Eff. 7/2/2007

e. Limitations of the method/instrument, including interferences: f. Baseline method/instrument characteristics for evaluating future performance: g. Testing of known samples resembling the expected range of case work specimens; indicate if the known samples will be internally, externally, or collaboratively: h. Assessment of accuracy & precision at concentrations expected in case work (quantitative methods only): i. Upper and lower limits of method/instrument sensitivity: j. Method/instrument reproducibility: k. Other objectives: 6. Proposed timetable a. The proposed validation project period Start: End: b. Experiments/studies to be completed: Project quarter 1: Project quarter 2: Project quarter 3: Project quarter 4: Approvals:

Unit Supervisor: ____________________________________ Date ___________ Section Chief: ______________________________________ Date ___________ Quality Manager: ___________________________________ Date ___________

PES Validation Plan Eff. 7/2/2007