T RACEABILITY OF R ECORDS

M EI B ETH S HEPHERD 3 rd Party Assessors Consultants

STS Assessors – Michael Shepherd – Mei Beth Shepherd – Tom McAninch – Michael Hintz – Mary Wehbe

Traceability?

Traceability Formal Definitions: International Vocabulary of Metrology: – Property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. Wikipedia: – The ability to verify the history, location, or application of an item by means of documented recorded identification.

Traceability Mei Beth Definition: The ability to show why the stuff that comes out at the end of a test (process) is as good as the “original” references.

Records?

Records ISO Definition: ISO/IEC 17025: Note 2 – Technical records are accumulations of data and information which result from carrying out tests and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal test reports and calibration certificates, customers' notes, papers and feedback.

Records Mei Beth Definition: All the information you enter on (controlled) documents (paper and electronic) in your laboratory.

How do we “Trace” our “Records”

Calibrate Everything Standards Reference Materials Reagents Working Standards Equipment

Standards Reference items calibrated to an NMI – Class 1 weights – NIST Thermometer Keep Calibration Certificates Usually purchased from ISO vendor

Reference Materials Used to calibrate within the laboratory – Calibration Standards Document open date and expiration date Keep Certificates of Analysis (CoAs) Usually purchased from ISO Guide 34 vendor Unique ID

Reagents / Critical Consumables IDEXX bottles/Filters/Sterile Pipettes Down to the pH strips Document open date and expiration date Verify on per lot basis Unique ID for each lot

Equipment Instruments Support Equipment – Pipettes – Thermometers – Balances – Refrigerators/Freezers – Water Baths/Hot Blocks – Ovens/Furnaces/Incubators Unique ID

Working Standards Which Standards and Reagents used? How much of each Standard and/or Reagent was used to create? – Recipe in an SOP is not good enough What equipment was utilized to create? Creation and expiration date Unique ID

Maintain info for Samples Which Standards and Reagents/ Working Standards were used? – Preparations – QC What equipment was utilized to prepare/analyze?

H ORROR S TORIES

Unpreserved Samples A laboratory discovered that many samples were coming in without enough preservative. An exhaustive Corrective Action search led to the information that a bottle top dispenser was not dispensing the assigned amount. Without knowing which samples were preserved with that dispenser ALL samples would be suspect and potentially need qualification.

Bad lot of Sample Bottles Bottles in use prior to verifying volume in laboratory. When verifying determined volume full line was off by 2 mL. If Bottle lot not identified ALL samples would need volume verified or qualify data.

Examples from your laboratory?

Q UESTIONS ?