Internal Quality Audits (4.14)

1
Internal Quality Audits (4.14)

• - ISO 15189 Requirements for Internal Audits
• - The Audit Process
• - Templates for Meeting Requirements

2
Requirements for Internal Quality Audits

• All elements 15 management and 8 technical of ISO
  15189 should be audited during a calendar year.
• Must have a procedure for planning and
  implementing internal quality audits so as to
  verify the elements and systems of the quality
  management system are implemented and effective.

3
Requirements for Internal Quality Audits

• Audits should be planned and performed by the
  Quality Manager/ Officer or nominee
• You cannot audit your own activities
• The procedure for internal audits should define-
• - Audit types vertical/ horizontal to be
  performed
• - Frequency of these audits (schedule)

4
Requirements for Internal Quality Audits

• The procedure for internal audits should define-
• - Methodology for performing the audit
  including reporting and close out processes
• - Corrective action/ preventative action must
  be documented and taken within an agreed time
  frame
• Results of internal audits form part of the
  Quality Management System review process

5
The Audit Process

• What is an audit?
• It is a planned or documented activity planned
• in accordance with written procedures and
• checklists, to verify by examination and
• investigation of objective evidence, that
• applicable elements of a quality programme or
• plan have been developed, documented and
• effectively implemented in accordance with
• specified requirements.

6
The Audit Process

• Depth of Audit
• Horizontal audit (system audit)
• Will verify that each element of the quality
• management system are described,
• implemented and effective e.g.
• 4.1 to 4.15 15
• 5.1 to 5.8 8
• Total of 23 elements

7
The Audit Process (Depth of Audit)

• Vertical Audit
• - Will review in detail the testing
  departments in a laboratory.
• - All testing departments should be audited
  over the course of 12 months.
• - A vertical audit is designed to cover
  activities from procurement of specimen to
  issue of results.
• - The audit uses the details of 2 known
  specimens

8
The Audit Process (Depth of Audit)

• Vertical Audit
• The auditors must consider-
• Man (trained, competent, motivated)
• Materials (traceable, correct type, passed
  incoming inspection, correctly used, cleaned
  etc.)
• Machine (calibrated, validated, maintenance QC)
• Method (clear, up to date, correct version)
• Mileau (temperature, particulate count, humidity
  etc.)

9
The Audit Process (Depth of Audit)
System audit e.g. 4.1 (horizontal)

• What are we looking for-

Vertical audit e.g. haematology
Which has more depth horizontal or vertical?
10
The Audit Process

• Audit process (same for internal, supplier or
• extrinsic audits)-
• Preparation and planning
• Performance of the audit
• Exit meeting
• Audit report
• Follow up

11
The Audit Process

• Audit Planning
• Audit schedule (12 month plan) horizontal and
  vertical is issued to Laboratory Management
• Appoint trained personnel to perform the audits
  lead auditor (independent)
• Notify the auditee at least 1 week in advance.
  Confirm in writing the timetable and personnel
  involved

12
The Audit Process (Planning)

• Identify, obtain and review all relevant
  documentation prior to the audit relevant to the
  scope of the audit.
• - previous audit reports (follow up)
• - quality manual
• - procedures
• Develop audit checklist or have them pre prepared
  for horizontal or vertical audits. The audit
  checklist controls the continuity and depth of
  the audit.

13
The Audit Process (Performance)

• Entry meeting (2 mins)-
• - Introductions
• - Confirm purpose/ scope
• - Timetable including time for exit meeting
• - Confirm escorts for duration of the audit

14
The Audit Process (Performance)

• 1 hour to 1 day
• Obtain objective evidence to verify compliance/
  non compliance and document same on checklist
  documentation.
• Questions should be asked to illicate full
  response.
• Following completion of the audit and before the
  closing meeting the audit team will meet to
  evaluate the evidence and agree on non
  conformances found and their classification.
• A list of non compliances is then made.

15
The Audit Process (Performance)

• Exit Meeting (5 mins)
• The lead auditor controls the exit meeting.
• The exit meeting will focus on-
• - the outcome of the audit
• - ensure the auditee understands and accepts
  the findings.
• - agree date for the final release of the audit
  report.
• - agree dates for close out of non conformances

16
The Audit Process

• Audit Report
• The formulation of the audit report must
  contain-
• - cover sheet.
• - a report sheet with corrective action report
  and agreed action and close out dates.
• - non conformances (corrective action requests)
  including classification.

17
The Audit Process

• Audit Report contd
• General observations should be noted including-
• areas audited
• activities found satisfactory
• activities with concerns

18
The Audit Process

• Follow up
• Quality Assurance Manager/ Officer/ Nominee
  verifies actions are closed out within an agreed
  time frame.
• Upgrade to major if not closed out within the
  agreed time frame.

19
The Audit Process

• Characteristics of a Good Auditor
• Good knowledge of the activity being audited
• Communication skills (articulate)
• Objective (stick to the facts)
• Open minded
• Good listener
• Observant
• A process approach
• Meticulous

20
The Audit Process

• Characteristics of a Good Auditor contd
• Impartial
• Professional
• Diplomatic
• High degree of integrity
• Patient
• Self driven and disciplined
• The auditor should never be aggressive no matter
  what happens

21
The Audit Process

• Characteristics of a Good Auditor contd
• Summary
• A good auditor should be a guide, philosopher
  and a friend.

22
The Audit Process

• Number of Trained Auditors
• At least one per discipline
• Auditors must write their own reports and
• follow up the close out of corrective actions

23
Templates for Meeting Requirements

• Templates provided are-
• Template 1 Internal Quality Audit Schedule
• Template 2 Internal Audit Report Lead
• Sheet
• Template 3 Checklist for Vertical Audit
• Template 4 Checklist for Horizontal Audit