Photocopies

Occasionally need uncontrolled
copies
 induction?
 information
for client?

Mark copy as uncontrolled

Explain how in documentation
Handwritten Amendments

May be permitted

Explain how in documentation

Must be authorised

All copies must be amended

Minimise
Control of Records

Documented procedures, records of:
 testing
 equipment
 internal
calibration
audits
 management
 corrective,
review
preventive actions
Control of Records

What was done

Who did it

Immediate recording

Preservation

Alterations - no erasure
Internal Audits
Outline

What is an internal audit ?

Types of Audits

How to meet standard requirements

Effective auditing

Preparing for an audit

Conducting an audit
Internal Audits Required:

By ISO 9000
 clause

4.17
By ISO/IEC 17025
 clause
4.13 (management requirements)
What is an Internal Audit ?

Systematic and independent examination of
the quality management system (QMS)

By someone within the organisation

In addition to external audits
The Internal Audit Process

Scheduled Audits
 programme
 examine
 identify
managed by Quality Manager
documents, results, processes
problems
 improve

Unscheduled Audits
 investigate
 improve
problem
Why Internal Auditing ?

Is QMS implemented exactly as intended ?

To investigate a problem
 why
did it occur ?
 how
can it be resolved ?
 how
can it be prevented in future ?

Identify opportunities to improve

Does the QMS meet requirements of
standards ?
Types of Internal Audits

Horizontal
 all
departments audited against one
element of standard or procedure

Vertical
 one

department audited against all
element of standard or procedure
Standard Requirements:
ISO 9001 and 17025

Audit program

Documented procedures

Auditors independent of activity

Audit results documented and reported
to management

Prompt action after problems identified

Follow up activities
Management’s Responsibility

Define internal auditing policy

Assign responsibility of internal audit
program
 Quality

Manager
Must be advised of internal audit
outcomes
 discussed
at management review
Quality Manager’s
Responsibility

Establish & maintain internal audit
system

Develop schedule

Coordinate audits

Manage corrective action system

Advise management audit outcomes
Who Audits ?

Trained & qualified auditors

Quality Manager selects and trains
internal auditors
 observer
on Quality Manager’s audits
 fist
audit under supervision of qualified
auditor

Independent of the activity to be audited
Audit Schedule

Annual

Address all elements of the quality system
 not

all departments
Frequency ?
 critical
areas
Documents used in Internal
Auditing

Checklists

Corrective action request forms

Audit report forms
Documenting the Audit
Program (1)

Quality Manual
 quality
policy on internal auditing
 responsibility
for internal audits
Documenting the Audit
Program (2)

Internal audit procedure(s)
 selection
and training of auditors
 scheduling
audits
 responsibilities
 preparation,
 identifying,
of auditors
conducting and reporting on audits
resolving and following up
corrective actions
 reporting
audit results to management
Effective Auditing (1)

Gather evidence about compliance with
quality system or standard
Effective Auditing (2)

Gather information about:
 process,
 staff,
operating procedures
equipment, test methods
 environment,
 quality
handling of samples
control, verification activities
 recording
and reporting practices.

Compare with documented system

Identify breakdown in system or departure
from procedures
What to Audit

Systems audit
 adherence

to documented procedures
Technical audit
 Technical
correctness
 adherence
to documented procedures/test
methods
 auditor
must have technical knowledge of
test

Combination
 vertical
audit
What to Audit - Technical Audit

Staff

Methods

Equipment

Testing Environment

Samples and Test Items

Quality Control

Computers

Records and Reports
Audit Preparation

Quality Manager determines
 audit
team
 lead
 audit
auditor
details
 scope
 time,

of audit
date, duration
Contact auditee
 date,
time, type & duration
1. Audit Plan
2. Develop Checklists
3. Opening Meeting
4. Gather Evidence
5. Record Results
6. Closing Meeting
7. Audit Report
1. Audit Plan

Objectives & scope

Collect documents
 standard,
procedure, work instructions,
forms
 desk

top review
History
2. Developing Checklists

Guidelines

Review documents
 identify
important aspects of the activity
 list
in logical order
 set
of questions
P-AD-0012 3.5 Audit Follow-up Activities

It may be necessary for a follow-up audit to be
performed to verify the effectiveness of any
corrective action carried out. Corrective action, and
subsequent follow-up audits, should be completed
within a time period agreed to by the auditee, in
consultation with the auditor.

The Quality Manager should schedule the follow-up
audit and enter details on the Audit Schedule and the
Audit Status Log.
AUDIT CHECKLIST (Reference P-AD-0012)
Reference
(clause/procedure)
Question/Requirement
P-AD-0012
Internal Audits – Follow-up Activities
3.5
When are follow up audits performed ?
Why ?
CHECK – are follow-up audits performed ?
CHECK – are time periods specified
Where ?
In conjunction with auditor ?
CHECK - are follow-ups completed by the
specified time period
Who schedules follow-up audits ?
How?
CHECK - are details entered on the:
Audit Schedule ?
Audit Status Log ?
Document Control:
CHECK – are all forms and documents reviewed:
Correct version ?
Authorised ?
Stored correctly ?
* A = acceptable, NA = not acceptable, NI = needs improvement
Audit Number: 1
Observations
Page1 of1
Compliance
(Y/N)
3. Opening Meeting


Who ?

auditor/audit team

auditee

any staff from area to be audited that may be
interviewed
What ?

Scope

expected duration
4.1 Gather Evidence about
Compliance

Interviews
 ask
questions about system and its
implementation
 who,
 other
what, when, how, where, why ?
questions
 direct
 hypothetical
 clarifying
4.2 Gather Evidence about Compliance

Examine documents
 procedures, work instructions, forms, quality
manual
 copies controlled ?
 available ?
 correct issue status ?
 used in manner intended ?

Quality Records
 stored correctly ?
 used as objective evidence
 many forms
4.3 Gather Evidence about Compliance

Observe activities
 what
is said or written may not reflect
practice
 “show me”

Examine facilities
 as
travel through laboratory/offices
 examine:
 equipment
 standard
of housekeeping
 size and layout of working area
 environment eg. temperature in lab
5. Recording Results

Record on checklists
 activities
which do not adhere to quality
system
 may
be classified
 major
non-conformance
 minor
non-conformance
 areas
for improvement
6. Closing Meeting(s)

Audit team meeting
 discuss

audit results
Closing meeting
 discuss
corrective actions
 determine

resolution dates
Identify corrective actions
 use
corrective action forms
7. Audit Report
Audit details
 Summary of findings

 corrective
actions
 numbered
 objective
evidence
 reference the document
 observations

Distribute
Corrective and Preventive Action
Outline

What is a corrective action ?

What is a preventive action ?

Corrective and preventive action
program

Corrective and preventive action
process
Corrective & Preventive Action
Required:

By ISO 9000
 clause

4.14
By ISO/IEC 17025
 clause
4.10 corrective action
 clause 4.11 preventive action
Corrective Action

An action taken to correct a problem
 incorrect
result
 departure
from procedure
Preventive Action

A proactive process to identify
 improvement
 potential
opportunities
sources of non-conformance