RISK Impact Exercise for Traceability and Calibration Programs 20221129.docx 

Traceability RISK Assessment Form Objective: Identify and analyze potential events and risks in the Calibration Laboratory related to the e

Traceability.

 IDENTIFY ANA

Essential

Element Element Description RISKS CONTROLS IN PLACE PROBABILITY (0 % to 100 %) 

1 Realization of SI Units2 Unbroken Chain of Comparisons3 Calibration Program4 Documented Measurement Uncertainty5 Documented Procedures6 Accredited Technical Competence7 Ensuring Validity (Measurement

Assurance)

Note: Modified tables from those presented in “Managing the Metrology System” by C. Robert Pennella, ASQC 
RISK Impact Exercise for Traceability and Calibration Programs 20221129.docx 

Calibration Program Components 

Iterative steps – review and update if needed during the program. IDENTIFY AN

Component Component Description RISKS CONTROLS IN PLACE PROBABILITY (0 % to 100 %) 

1

PLAN

Identify Scope, Maintain a Complete Inventory

(Equipment and Standards, Calibration Certificates)

for your laboratory; update CMC when appropriate

(consider “internal scope” needed to support your

own traceability)

2 Ensure staff are competent through training,

proficiency testing, and ongoing monitoring of

competency in providing calibrations and

document all training and monitoring of staff

competency.

3 Ensure suitable calibration intervals are planned

and documented, determine an established

baseline (plus DO monitoring); update if/as needed

4

DO

Schedule Calibrations (on your calendar, with

supplier(s) – even if that is your own lab; will likely

require evaluating your own workload and

availability of standards)

5 Document and follow shipping, handling, use,

storage, maintenance procedure(s) are defined

and followed

6 Schedule Internal Audits (Specifically in this case to

assess “traceability” and the “calibration program”.

Conduct assessments. Document observations

from all steps in the calibration program

7 Implement procedure for calibration supplier

selection and Perform complete Supplier

Evaluation (including maintaining history);

evaluate and save the supplier CMC prior to use
RISK Impact Exercise for Traceability and Calibration Programs 20221129.docx 

Iterative steps – review and update if needed during the program. IDENTIFY AN

Component Component Description RISKS CONTROLS IN PLACE PROBABILITY (0 % to 100 %) 

8 Request budget approvals and process financial

requests

9 Conduct Contract Review discussions with Supplier

(include discussion and agreement of decision

rules and specification evaluations) – expect and

plan for this step; they are required to do this with

you as the customer

10

CHECK

Evaluate Returned Calibrations and Certificates,

Evaluate “calibration stickers” or “due dates” if

present (request action from suppliers)

11 Update Supplier Evaluation history, Provide

customer feedback to your supplier

12 Document any corrective or preventive action

taken based on the evaluation of returning

artifacts (and document observations and guidance

for future use)

13

ACT

Update Laboratory Documents and Records

(hierarchies, inventories, spreadsheets,

uncertainties, observations, corrective actions);

File and retain certificates

14 Conduct statistical evaluation and adjust Intervals

(if needed) using data following documented

procedures and using data from control charts,

uncertainties, PTs, calibration history (i.e.,

adjustment is a defendable and documented

technical assessment, not a financial decision)