Corrective Action Request

Purpose

Records a corrective action request from identification of the nonconformity through containment, root cause analysis, action planning, implementation and verification of effectiveness. Also used (marked IMPROVEMENT) to record improvement proposals and their outcome.

What it covers

• 1. Nonconformity (or improvement opportunity)
• 2. Correction and containment
• 3. Root cause and extent
• 4. Corrective action plan
• 5. Effectiveness verification
• Authorisation

How to complete it

1. 1.Number as CAR-YY-NNN (or IMP-YY-NNN for improvements). Record the source (audit, complaint, NCW, PT, accreditation body, supplier, management review, staff).
2. 2.Describe the nonconformity factually with the requirement not met and objective evidence; attach the source record.
3. 3.Record correction and containment first, including the impact assessment on issued results (link FRM-13).
4. 4.Complete the root cause analysis on FRM-09 and summarise here; 'human error' is not accepted without a further 'why'. Record the extent check.
5. 5.The Quality Manager reviews the action plan for adequacy before approval. After implementation, define the effectiveness check and perform it after sufficient time; close only with evidence.

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-05

  Corrective Action and Improvement

  Raising, investigating, implementing and verifying corrective actions; capturing improvement opportunities.

• FRM-06

  Audit Finding and Nonconformity Report

  Records an audit finding with classification, objective evidence and required response.

• FRM-09

  Root Cause Analysis Worksheet

  Five-whys and cause-and-effect (fishbone) worksheet supporting corrective action.

• 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.

• FRM-03

  Records Retention Schedule and Disposal Log

  Retention periods by record type and a log of authorised disposals.