Non conforming Works

Definition

A non-conforming work is a test session, based on a contractual framework, which is not performed in conformance with the rules of the lab (procedures, quality manual...). The test session process is in particular followed. In case of KEREVAL Health Lab, non-conforming works that potentially affect the test results are targeted.

Applicable scope

Any issue that could occur regarding the different elements that compose the test platform  (developped or used by KEREVAL Health lab, or IHE test plans, provided by the IHE test design team).

Objectives

  • Detect as soon as possible eventual non-conforming works
  • Identify impact of this non-conformances on test results (already delivered or currently in progress)
  • Make able appropriate decisions taking, in order to avoid or reduce such impact

Prerequisites

Several warnings of a potential non-conforming work : 

  • either a defect is detected on any test tool, during development or during a test session
  • or the test session process is not fully respected (such finding can be detected during internal quality checks)
  • or a claim from a customer is raised, and approved by the CTO
  • or a known issue on a test case is raised

Inputs

  • Issues, in JIRA

or

  • Finding in the applied process, documented in a Quality report

or

  • Customer claim, in TUTOS

Actions

  • In case of an issue created in JIRA, the test tool development manager applies the test tool development process. An impact analysis is documented directly in the JIRA issue, including a dedicated analysis on potential impact on test results.
    • In case of impact on test results (current or already provided), the test tool developpment manager raises the issue to the lab manager.
  • In case of a non respect of the test session process, detected by any quality check, review or internal audit, the finding is raised to the lab manager, who analyses potential reasons and impacts.
  • In case of a customer claim, the lab manager analyses the potential causes and reasons.
  • In case of an issue on IHE test cases, any report containing this test case, provided before the detection, remains still valid. Anyway,KEREVAL Health lab will keep informed the concerned customer.
  • If a non-conforming work is confirmed by the lab manager after such analyses, he keeps the quality manager informed, who will create a TUTOS incident (category : "travail non-conforme/non-conforming work" and gravity is assessed (Léger/Light | Important/Important | Bloquant/Blocking). 
  • The Quality Manager keeps the Sales manager and the CTO informed during production review, or directly if the incident is "blocking".
  • The Top Level Management committee decides the action that must be taken. 
  • Several types of actions are possible, according to the level of importance and its frequency of occurence :
    • communication or not to concerned customers
    • new run or not of the concerned tests
    • decide or not of a commercial action to satisfy the customer
    • decide or not to review the staff qualification
    • decide or not of an improvment or corrective action on test tools development practices.
The Quality Manager is in charge of following till closure the opened incidents, and of providing to the top level management regular reporting.

 

Outputs

  • TUTOS incidents, category : travail non-conforme/non-conforming work, on IHE projects

Closure criteria

  • TUTOS incidents, category : travail non-conforme/non-conforming work, on IHE projects, are closed

Tools

  • TUTOS
  • JIRA