Good Laboratory Documentation Practices

D. M. R. D. Dhanapala, Act. Principal , School of MLT,NIHS,  Kalutara

Documentation should permit the complete reconstruction of a study/process.

–       Record data directly, promptly and legibly in indelible ink (never pencil)

–       Initial and date all observations and any resulting changes, but do not obscure original data

–       Initial and date only work you’ve performed

–       Do not document selectively or in advance of performing the activity

–       Do not use white-out correction fluid or tape

–       Do not use  marks

–       Copy all heat sensitive paper and stamp “exact copy”

–       Verify critical calculations using a second person and document that

–       Notebook pages requiring a second signature shall be completed with that signature

–       Properly head all pages, tables, columns; identify units

–       Describe Statistical & Calculation Procedures used

–       Sign, Date, and File automated printouts (e.g., QC forms)

–       Retain all Raw Data (original records) in the Study File

–       Do not document by exception.  Use positive documentation, even if only a check marks.

–       Documentation must allow another person to be able to accurately reconstruct what you have done

–       Keep all original observations including those observations recorded directly into a computer

–       Sign and date all computer printouts

–       Never back-date anything

–       Follow SOPs and Protocol

–       Document all deviations with accompanying explanations

–       Indicate in the record all applicable units and equipment used

Raw Data Correction

•        All changes to raw data must be made without obscuring the original entry

•        All changes must be initialed and dated by the person making the change, accompanied by an explanation for the change

Abbreviations for Reasons-

Notation	Meaning	Definition
EE	Erroneous Entry	Entry of a wrong number or incorrect word
SP	Spelling Error	Entered word is misspelled
RD	Repeated Data	Data are already correctly entered elsewhere
MC	Miscalculation	Number shown is the result of a miscalculation
NL	Not Legible	Entry is illegible or has been overwritten
OE-OK	Original Entry OK	Ignore single line cross-off
STET	Original Entry OK	Ignore single line cross-off

Reference : ISO 17050 Guidelines for laboratory Documentation

A  Quality Laboratory Documentation system includes followings

I- Testing strategies / protocols

    - Specimen identification

    - Confidentiality

II – Standard Operation Procedures

    - Sample processing

    - Test performance and result interpretation

Deming Cycle(Plan Do, Check & Act)

,    - Inspection of incoming goods

    - Validation

    - Equipment maintenance and calibration

    - Safety

III-Records

    - Test results

    - Equipment maintenance

    - Equipment calibration

    - Control charts

    - Validation

    - Training