Quality Control Chart Log

Purpose

The record for a check standard control chart: the QC plan for the chart (what, how, when, limits, who), the tabulated results, the plotted chart (attached or in the validated workbook) and the monthly reviews, per SOP-17 section 6.3.

What it covers

• Results
• Reviews

How to complete it

1. 1.Complete the plan header once per check standard and point; re-establish limits after 15 points or after a change of reference.
2. 2.Enter each result at the time of measurement, with the chart rule check; plot on the chart (attach printout from the validated workbook or the paper chart).
3. 3.Apply the rules: 1 point beyond 3 s; 2 of 3 beyond 2 s same side; 7 consecutive same side or trending. On breach, stop, repeat, report (SOP-17 section 6.4).
4. 4.Record the monthly review by the discipline lead and the quarterly review by the Technical Manager.

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-17

  Ensuring the Validity of Results

  Quality control, control charts, intermediate checks, proficiency testing and interlaboratory comparison programme.

• SOP-30

  Intermediate Checks of Reference Standards and Equipment

  Checks between calibrations that maintain confidence in the calibration status of reference standards.

• 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.

• FRM-04

  Internal Audit Programme and Audit Plan

  Annual audit programme covering every clause and activity, plus the plan for a single audit.