Competence Assessment and Witness Record

Purpose

Records the structured assessment of a person's competence for a specific activity before authorisation and at annual monitoring, including witnessed performance against the procedure, review of work produced, questioning, and the assessor's decision.

What it covers

• 1. Witnessed performance
• 2. Review of work produced
• 3. Questioning
• 4. Decision
• Authorisation

How to complete it

1. 1.Complete one form per activity assessed (procedure, range, location). The assessor must be authorised for the activity and must not be the trainee's sole trainer where practicable.
2. 2.Witness the complete activity and score each element: 2 = performed correctly without prompting, 1 = minor prompt needed, 0 = not performed correctly. Any 0 in a critical element fails the assessment.
3. 3.Review at least five jobs performed under supervision (initial) or since the last review (annual) and record findings.
4. 4.Ask the questions listed and record the adequacy of answers. For signatories include seeded-error data review.
5. 5.Record the decision (authorise / authorise with restrictions / continue supervision / withdraw) and transfer to FRM-16.

Before you use it

• Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
• Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
• Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
• Record the document in your own document register and set its review date.

Related documents

• QM-01

  Quality Manual

  Top-level description of the management system against every clause of ISO/IEC 17025:2017.

• SOP-09

  Personnel Competence, Training and Authorisation

  Competence requirements, induction, training, supervision, authorisation and ongoing monitoring of personnel.

• FRM-14

  Personnel Training Record

  Individual training history with objectives, delivery, evaluation of effectiveness and authorisation links.

• FRM-16

  Authorisation Matrix

  Who is authorised to perform, review, authorise and report each activity.

• FRM-44

  Skills Matrix and Training Needs Analysis

  Competence levels per person per activity and identified training needs.

• CHK-01

  ISO/IEC 17025:2017 Gap Analysis and Self-Assessment

  Clause-by-clause self-assessment with evidence, gap and action columns.

• FRM-01

  Master Document Register

  Register of every controlled internal and external document with revision, status and distribution.

• FRM-02

  Document Change Request

  Request, impact assessment and approval of a change to a controlled document.