World Leader in Environmental and Analytical Chemistry

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Ana-Lab Corp.
P.O. Box 9000 2600 Dudley Road Kilgore, TX
75663 http//www.ana-lab.com
World Leader in Environmental and Analytical
Chemistry
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INTERNAL AUDITS
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Internal Audits

• Say what you do
• Do what you say
• Prove it

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OBJECTIVES

• Review ISO 17025 requirements for internal audits
• Develop a Basic Internal Audit Program
• Learn to gather Objective Evidence

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REVIEW OF ISO 17025

• 4.13 The laboratory shall periodically, and in
  accordance with a predetermined schedule and
  procedure, conduct internal audits of its
  activities to verify that its operations continue
  to comply with the requirements of the quality
  system and this international standard.

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The internal audit shall address all elements of
the quality system, including the testing and/or
calibration activities. It is the responsibility
of the quality manager to plan and organize
audits as required by the schedule and requested
by management.
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• Such audits shall be carried out by trained and
  qualified personnel who are, wherever resources
  permit, independent of the activity to be audited.

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What is an Internal Audit?

• A systematic and independent examination to
  determine whether quality activities and related
  results comply with planned arrangements and
  whether these arrangements are implemented
  effectively and are suitable to achieve
  objectives.

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Definitions

• Shall Imperative
• Should Strongly suggested
• Policy What must be done
• Procedure How it must be done
• Documents Policies, Procedures, SOPs, Manuals,
  Records
• Records History of activities

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Quality System

• Commitment to Good Professional Practice
• Statement of Standard of Service
• Quality Objectives
• Requirement that all personnel be familiar with
  the quality documentation, policies and
  procedures
• Commitment to Standard ISO 17025

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Quality System

• Policies
• Procedures
• Work Instructions
• Equipment and calibration
• Measurement traceability
• Identification of training needs

• Training and personnel qualifications
• Environmental monitoring
• Records

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Quality System
Quality Manual Related Quality Documentations
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Quality Manual
Quality Policy Management Roles Structure of
Documentation
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Quality Documents

• Quality objectives of the organization
• Policies, procedures and operation instructions
• Mechanism for communication of policies and
  procedures
• Basis for audit and review of the quality system

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Quality System Documents

• System Documents
• Quality Manual
• Quality Policy Objectives
• Document control procedures

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Quality System Documents

• Procedure Documents
• Testing processes (SOPs)
• Test methods
• Sampling methods
• Calibration
• Data recording

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Quality System Documents

• Records Management
• Results
• Test records
• Test reports
• Calibration records
• Traceability

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Quality System Documents

• Training and Qualifications
• Organization charts
• Job descriptions
• Training records

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Quality System Documents

• Interface Documents
• Client contacts
• Client orders (contract review)
• Reports of test
• Purchase orders
• Sub-contracts vendor list
• Equipment list

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Structure of Documentation
Quality Manual System Procedures Test
Methods Work Instructions Record Management
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Internal Audits Requirements

• Rule 1
• Non-conformance must be expressed in the words of
  the quality system standard, the appropriate
  technical specification or test method, or the
  companys own policies and procedures.
• See Exercise A

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Internal Audits Requirements

• 4.13.1 The Quality Manager shall be responsible
  for the audits
• Such audits shall be carried out by trained and
  qualified personnel who are, where resources
  permit, independent of the activity to be audited.

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Internal Audits Requirements

• 4.13.2 When audit findings cast doubt on the
  effectiveness of the operations or on the
  correctness or validity of the laboratory
  results, the laboratory shall take timely
  corrective action, and shall notify clients in
  writing if investigations shows that the results
  may have been affected.

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Internal Audits Requirements

• 4.13.3 Records
• The area of activity audited, the audit findings
  and corrective actions that arise from them shall
  be recorded
• 4.13.4 Follow-up
• Follow-up audit activities shall verify and
  record the implementation and effectiveness of
  the corrective action taken

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Internal Audits Summary

• Schedule
• Develop procedure for audit
• Compliance based
• Trained auditors
• Record findings
• Timely corrective actions
• Notify clients of data problems

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Internal Audits are

• An organizations own process for monitoring the
  correct implementation of its own quality system.

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Procedures for Internal Audits

• Ensure the audit procedures meet ISO 17025
  requirements
• Specify responsibilities
• Define authority and responsibilities of auditors
• Schedule audits
• Determine scope of audit

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Procedures for Internal Audits

• Train auditors
• Detail steps involved in the audit
• Prepare forms and checklists
• Authorize auditors
• Perform audit
• Complete records
• Implement and follow-up on corrective actions

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Auditor Training

• ISO 17025 Laboratory Quality System
• The Human Relation aspect
• Ana-Labs auditing procedures
• Planning
• Scheduling
• Conducting
• Reporting
• Information gathering techniques

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Auditor Training

• Human Relation Aspects
• Buy into the process
• Communication skills
• Listening skills see, hear, experience
• Define the scope of the audit
• Which procedure?
• Which people?
• Which approach?

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Planning the Audit

• Review all requirements, policies and procedures
• Prepare checklist
• List questions to be asked
• Review again
• Inform auditee

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Conducting the Audit

• What information do I need?
• How will I get the information/evidence?
• With what will I compare the information?

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Asking Questions

• Direct questions establish facts
• Hypothetical questions promote understanding
• Clarifying questions prevent misundnerstanding

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Information or Evidence?

• Information is what you hear or read
• Evidence is what you see
• We must go and see

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Examining Documents

• Documents available for use?
• Is there proper document control?
• Are changes properly made?
• Are obsolete documents removed?
• Do technicians follow written procedures?

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Examining Records

• Are quality and technical records in place
• Are procedures followed for recording data?
• Are error corrections properly made?
• Are records completed in real time?

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When Something Seems Wrong

• Is it really wrong?
• Does the technician know its wrong?
• What is their explanation?
• Did QC detect the error?
• CAR initiated?
• Are results affected?

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Audit Report

• Date
• Auditor
• Area of activity audited
• Requirements
• References
• Findings
• CAR
• Follow up activities

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Internal Audits Requirements

• Rule 1
• Non-conformance must be expressed in the words of
  the quality system standard, the appropriate
  technical specification or test method, or the
  companys own policies and procedures.

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Summary

• Internal audits are compliance based
• Management reviews are improvement based
• Non-conformances are written only when objective
  evidence indicates
• Non-conformances must relate directly to the
  standards