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Welcome to

ISO 9001:2000 version



Internal Auditing
Training Course
Internal Audit Cycle
Audit
Systematic,independent and documented
process for obtaining audit evidence and
evaluating it objectively to determine the
extent to which audit criteria are fulfilled.

Monitoring and Measurement tool of the
Quality Management System
Auditing
Types
First Party Audit

Second Party Audit

Third Party Audit
Why Auditing
The requirements of the ISO 9001:2000
under clause 8.2.2
To fulfill Regulatory Requirements
Customer Requirements
To find actual & Potential departure from the
defined system
To get opportunities for continual
improvements
ISO 9001:2000 Audit Requirements
Planned Intervals
Audit Programs
Audit Criteria
Audit Scope
Frequency
Methods
Selection of Auditor
Impartiality
Documented Procedure
Taking Corrective action with out Undue Delay
Follow up & Reporting of Verification Results.
Internal Auditor
A person who has the qualification to perform
quality audits
A auditor must be authorized for each audit
Persons selected as internal auditor shall be
Free from bias
Independent
of the activity
being audited
Free from
influence
Process Activities
+
Resources
Controls
(e.g. procedure)
Output
Input
Processes
Processes - interactions
Process A
Process B
Process
D
Process C
Process
Any activity that takes inputs
and converts them to outputs
Process Approach
The systematic identification and management
of these activities and the interaction between
activities.
How is a Process Managed?
Activity
Input Output
Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
Desired Results:
Quality Products
Quality Services
Customer Satisfaction
Monitor & Measure the Process
make sure the inputs are right, the transformation
activities consistently work, and the desired results
are achieved, then - improve the process as needed
How is a Process Measured?
Activity
Input Output
Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
Desired Results:
Quality Products
Quality Services
Customer Satisfaction

Efficient
No Waste
Effective
Desired Results Achieved
ISO 9001:2000
Conducting Top Management
Interviews
The expanded role of top management
requires more time be spent with them
during internal audits to collect evidence of
their commitment to:



_ Communicating importance of meeting requirements,
_ Establishing quality policy and objectives,
_ Conducting management reviews, and
_ Ensuring availability of necessary resources.

Interviewing
Process Owners
Other managers (i.e. Process Owners) should be
interviewed to collect evidence that:
_ Processes and improvement objectives are
documented and planned,
_ Processes and needed resources are deployed,
_ Processes are monitored and measured, and
_ Actions are taken, as warranted by analysis of
process data.
Note: Auditors should look for evidence that process
sequence and interrelationships are known
and interfaces are effectively managed to
achieve the desired objectives.
Management Style
Tell
This approach is where the team leader plans and
makes the decisions up front and then gives clear
instructions - directing the team the way he or she
wants the task to proceed
This style may well be welcomed by the less
experienced team members, but may not always
receive approval from those more experienced who
feel they have something to contribute.
Management Style
Consult
The consult approach is where the team leader takes
time to talk to the team members first, listen to their
ideas and evaluate their capabilities before making a
decision.
This is probably the preferred approach, but if time is
a constraint and the team ia not available then this
approach may not be possible.
Management Style
Team
The team approach is when the team leader acts
more as a chairperson seeking concise opinions and
allowing other team members to take an active role
in the decision making process.
This approach is perhaps more useful when
preparing for the final report. Giving the opportunity
for the final report to be truly representative of the
whole teams findings.
SECTION
Planning
AUDITEE AUDITOR
Non-conformance Statements
N Audit objectives
N Audit Schedule
N Notification of Audit




N Selection of Audit Team
N Prepare Checklist
N Audit Plan




N Audit team
N Auditee





N Audit team





N
N CAR (s) / Audit Report
N

CAR Status Log



N Team Leader





N Team Leader
N QMR
Planning
Preparation
Conduct Audit
Complete Audit /
Discuss Findings
Audit Report Back
and Recording
Follow - up
Close - out
-investigate cause of
nonconformance
-return completed CAR
-implement necessary
corrective / preventive
action and monitor for
effectiveness.
Initial Planning
Decide who shall carry out the audit
Identify the relevant quality specification or
requirements
Plan the date/time
Gather information
Detailed Planning

Prepare program - send copy to auditee
Decide team composition
Arrange team briefing
Team prepare checklists
IDENTIFYING PROCEDURES TO AUDIT
ISO Elements
Area
Stores
x x x x o x x x x x x
Product line 1
x x x x x x x x x x x x x
Q.A.
Legend: X = Direct Relationship
O = In-direct Relationship
EXAMPLE OF AN AUDIT PLAN
AUDIT PLAN
Procedure/
Department
JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
AUDIT KEY
P - PLANNED
P/D - PLANNED & DONE
U - UNSCHEDULED AUDIT PERFORMED
F - FOLLOW-UP AUDIT PLANNED
F/D - FOLLOW-UP COMPLETED
AUDIT ITINERARY
Time Team A (PM) Team B (WL)
09:00-09:15 Opening Meeting
09:15-12:00 Sales Department Engineering Department
- Contract Review - Document & Data control
- Customer Complaint - Product Design & Development
- Sample Control - Control of Production Fixture & Tools
PMC Department - Control of Inspection, Measuring
- Production Planning & Text Equipment
- Material Planning
12:00-13:)0 Lunch
13:00-13:30 Auditors Meeting
13:30-16:45 Store Production
- Material Store - Process Control
- Finished Store - In-process Inspection
Quality Department - Control of Non-conforming Products
- Incoming Inspection & Testing Personnel Department
- Final Inspection & Testing - Training
- Corrective & Preventive General Manager
Action - Internal Audit
- Management Review
16:45-17:30 Auditors Meeting
17:30-18:00 Closing Meeting
SECTION
Preparation
AUDITEE AUDITOR
Non-conformance Statements
N Audit objectives
N Audit Schedule
N Notification of Audit




N Selection of Audit Team
N Prepare Checklist
N Audit Plan




N Audit team
N Auditee





N Audit team





N
N CAR (s) / Audit Report
N

CAR Status Log



N Team Leader





N Team Leader
N QMR
Planning
Preparation
Conduct Audit
Complete Audit /
Discuss Findings
Audit Report Back
and Recording
Follow - up
Close - out
-investigate cause of
nonconformance
-return completed CAR
-implement necessary
corrective / preventive
action and monitor for
effectiveness.

Document review
The audit plan
Work documents
Audit checklist
Preparing for the on-site audit
Documents:
relevant QMS documentation and records
to verify the requirements of ISO 9001:2000 are
addressed.

Purpose:
to acquaint auditors with the processes to be
audited
devise an audit plan
develop a checklist
Document review
the processes taking places
relevant procedures
documents in use
records
requirements of ISO 9001
requirements of the quality
management system
Preparing a checklist
AUDIT PREPARATION
Checklist - Preparation
+ WHAT the auditor wants to look for

+ WHOM
the auditor wants
to speak to

+
WHAT the auditor wants to speak about

AUDIT PREPARATION
Checklist Questions
+ Based on Quality Documentation used by
the Dept.to be Audited.
+ From the documentation Identify all the
key things involved / to be done
+ Record the key things on the checklist
as things to be checked.
+ Include references to all forms and other
documentation, i.e. other procedures / W.I.


AUDIT CHECKLIST
Job Ref : NDB
Procedure: QP008 / Issue B / Rev.1 Auditor : P.C. Chan
Sheet No. 1 of 4
Item
No.
Requirement Comments/
Remarks
Activity Compliance
Yes/No
Receiving Check
For small packet, By Foreman
- Visual check
- Identified & Marked off against the P.O.
- Until required (what does it means?), unpacked/
inspected / put into store
For Plant / Equipment, By Foreman
- Quantity check against Engineers order
- Damage check
- For specialised equipment, need to sign DN,
may be by Chargehand
- Equipment Acceptance Cert send to Contract Engineer
By Foreman for all items:
- Check DN about Order No.,
Quantity or Weight
Suppliers name & her Order No.
Description

4.01




4.02





4.01
AUDIT CHECKLIST
Job Ref. : NDB
Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan
Sheet No. 2 of 4
Item
No.
Requirement Comments/
Remarks
Activity Compliance
Yes/No
- Check DN against PO
- Send test Cert to site eng.
If all Ok, sign Material Received Copy, send to Engg:
Dept with D.N.

IF Non-conformity found

Inform Contract Engineer
Indicated with Red Label with defects detail, separately
located
Disposition by Site Engineer
Fill Non-conforming item input sheet (Distribution
required?)
If found after stored, remedial work.
Record on either one
- Non-Conforming Item Report Sheet
- Non-Conforming Workmanship Report Sheet









4.01
4.06


4.11

4.09


SECTION
AUDIT Conduction
AUDITEE AUDITOR
Non-conformance Statements
N Audit objectives
N Audit Schedule
N Notification of Audit




N Selection of Audit Team
N Prepare Checklist
N Audit Plan




N Audit team
N Auditee





N Audit team





N
N
CAR (s) / Audit Report
N

CAR Status Log



N Team Leader





N Team Leader
N QMR
Planning
Preparation
Conduct Audit
Complete Audit /
Discuss Findings
Audit Report Back
and Recording
Follow - up
Close - out
-investigate cause of non-
conformance
-return complete CAR
-implement necessary
corrective / preventive
action and monitor for
effectiveness.
Auditor
Auditee
PERSONAL CONDUCT
positive, professional, constructive approach
co-operative, open, honest
People
Processes
Equipment / tools / materials
Documentation
AN AUDITOR "VERIFIES" BY
OBTAINING OBJECTIVE EVIDENCE
Sampling
Scope
Duration of Audit
Requirements of the
standard
Complexity of the
process
Considerations:
Previous Problems
Important aspects
Auditor skills /
knowledge
Sample size and its
significance
Support from management
Trained auditors
Independence of audit function
Timely access to facilities, documents,
personnel
Access to all levels of management
Defined audit procedures

FUNDAMENTAL REQUIREMENTS FOR
EFFECTIVE AUDITING
Record
Past implementation

Examined / Observed
Current implementation

Method Stated
Staff knowledge & understanding
OBJECTIVE EVIDENCE
meet the area representative first
always talk to those performing the task
explain the purpose of the visit
be calm, polite, reassuring
never talk down
speak clearly and carefully
THE AUDITOR'S APPROACH
examine objective evidence
ask open-ended questions
refer to checklists
make notes
consider impact on other activities
examine physical conditions
CONDUCTING THE AUDIT
ASK
LOOK
LISTEN
How
Where
When
What
Why
Who
QUESTIONING TECHNIQUES
6 important
words
be side-tracked
be led or misled
get "bogged down"
let the auditee dictate the pace
make assumptions or presumptions
CONTROL THE AUDIT
DO NOT
aggressive auditees
missing people
missing documents
pre-prepared samples (choose your own !)
BE AWARE OF
Be prepared
Be punctual
Insist on auditee answering questions
As little talking as possible
Avoid misunderstandings
Keep questions clear and concise
Polite and calm

CONTROL THE AUDIT
DO
good listener
open-minded
diplomatic
unbiased
honest
patient
self-disciplined
SELECTING AUDITORS
DESIRABLE TRAITS
opinionated
self-important
lazy
argumentative
shy
SELECTING AUDITORS
UNDESIRABLE TRAITS
stay within audit scope
communicate audit requirements
collate objective evidence
document CARs
report audit findings
verify effectiveness of corrective actions
retain and safeguard documents



AUDITORS SHOULD
Audit Techniques
Forward Trace
Background Trace
Vertical Audit
Horizantal Audit
comply with the Standard
implement quality manual, procedures or
other documented requirements
implement a code of practice, regulation
or contract
_______________

no requirement = no nonconformance
A NONCONFORMANCE MAY BE A FAILURE
TO:
Noncompliance Reporting
What is the Problem ?
describe clearly, concisely and
factually
Why is it a noncompliance ?
i.e. against what requirement
Where did it occur ?
i.e. which department or activity
Who ? - avoid apportioning blame
(i.e. naming individuals)
Noncompliance Reporting
Information to be recorded
Identification /Serial number
The nature of the noncompliance Where, What,Why
Reference numbers of Documents/ Materials etc.
Auditee/ contact
Clause of the standard or specification applicable
Category of noncompliance (if applicable)
Agreed corrective action and timescale
Follow up action
See Noncompliance Report Form
Standard: ISO 9001:2000

Procedure: QP6 Issue 2
Area: Purchasing Dept.

1. The procedure is not being implemented in full in
that not all purchase orders are being fully
completed. For example; Pos 1234 and 1235
do not contain prices or delivery dates.
2. All Purchase Orders must be completed in
accordance with Procedure QP6.
EXAMPLE OF
NON-COMPLIANCE STATEMENT
LAC 09.08 / 05
EXAMPLE OF CORRECTIVE ACTION REQUEST
Company:

Job No:

Assessor:

Company Representative:

Procedure No:
Issue:


Details of Non-Conformance:






Signed:
Company
Representative:

Corrective Action taken to prevent recurrence:






Signed:
Company Representative

Acceptance of Corrective Action/Comments











Visit No:

Assessment Date:


Area/Dept/Function:
CAR No.: of




ISO 9001/2/3/REF
Clause
Major CAR
Proposed
Close out date:
Signed:
Assessor:
Date:
:

NON-CONFORMANCE
STATEMENTS




L/C 341-6787 for a customer under credit grade of #
8 for the amount of USD 400,000 FOB, there was no
evidence of any insurance provided.
The procedure requires that for the issue of L/Cs to
customers under credit grade 7-10 over USD 325,000
under FOB and C&F terms evidence of insurance is
required.

NON-CONFORMANCE STATEMENTS




Customer complaint from the ABC company had not
been followed up and no action had been carried out
whatsoever.

According to the procedure QP 13 paragraph 4.6 all
customer complaints are to be followed up in the
Quality Improvement Committee.





SECTION
Audit Follow Up & Close Out
AUDITEE AUDITOR
Non-conformance Statements
N Audit objectives
N Audit Schedule
N Notification of Audit




N Selection of Audit Team
N Prepare Checklist
N Audit Plan




N Audit team
N Auditee





N Audit team





N
N
CAR (s) / Audit Report
N

CAR Status Log



N Team Leader





N Team Leader
N QMR
Planning
Preparation
Conduct Audit
Complete Audit /
Discuss Findings
Audit Report Back
and Recording
Follow - up
Close - out
-investigate cause of non-
conformance
-return complete CAR
-implement necessary
corrective / preventive
action and monitor for
effectiveness.
RESPONSIBILITY OF MANAGERS
RECEIVING A CAR
1. Investigate the problem

2. Determine the cause

3. Decide on appropriate corrective action


and target date for implementation.

4. Send the completed form to the CAR


administrator

5. Implement corrective action


C.A.R. FLOW
C.A.R. Raised
Signed & Issued Accepted
Investigate & Analyze
Implemented
Corrective Action Documented
Reviewed
Reviewed
Reject Accept
Closed Out
Record Record
INTERNAL AUDIT REPORT
INTERNAL QUALITY SYSTM AUDIT REPORT
AUDITORS NAME AUDIT REPORT NUMBER


DEPARTMENTAL REPRESENTATIVE DATE OF AUDIT


QUALITY FUNCTION or PREVIOUS AUDIT DATE AND RESULTS
PROCEDURES(S) AUDITED


SUMMARY AUDIT:







SIGNED: _______________________(AUDITOR) DATE: _______________________
exists
is complete
operates correctly
is effective
AIMS OF THE AUDIT
To verify that the quality system:
explain, support and justify findings

obtain agreement on CARs
ensure good points are mentioned
state overall degree of compliance
reinforce objectives and scope
PRESENTING THE FINDINGS

EPORT BACK MEETING

Have Your Reports Ready

Discuss Positive As Well As Negative Aspects

Make Sure Reports Are Agreed By All Parties

Subsequent follow up should review:


- audit file
c - corrective action file
Review should examine actions
required and whether completed and
whether the actions have been effective
to prevent recurrence.


shows status of:
CARs
follow-up action
close-out
CARs from second and third party audits

CAR STATUS LOG
CAR STATUS LOG
CAR CAR DEFICIENCY AUDIT INITIALS DATE CORRECTIVE ACTION PROPOSED DATE
SERIAL ISSUED DATE OF REMINDER ACTION PREVENT FOLLOW- CAR
NO. TO AUDITOR SENT COMPLETION RECURRENCE UP DATE CLOSED
DATE
CORRECTIVE ACTION REQUEST (CAR) STATUS LOG
Why ??
FOLLOW-UP OF
THE CORRECTIVE ACTION
To ensure corrective action has prevented
any recurrences
To determine whether corrective action has
been effective?
CLOSE-OUT THE CAR
> Each non-conformance is to be closed out
individually
Ensure that the corrective action has
addressed the root cause of the non-
conformance
Not treated the symptoms only but
prevented recurrence of the non conformity.
When the auditor is satisfied there is no
further example of the non-conformance.
MANAGEMENT REVIEW
internal audits reported

audit results analysed

status of corrective actions reported

preventive actions identified
INTERNAL AUDIT -THE SYSTEM
Management

Management
Review

Follow-up/
Close out

Audit Schedule


Corrective/
Preventive Action

Conduct Audit
CAR Requests
Thank you very Much
Cirin Pharmaceuticals (Pvt.) Ltd.

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