Corrective & Preventive Action
Programme

Corrective and preventive action managed
by one programme

Closely linked to the internal audit
programme
Managed by the Quality Manager
 Process managed using corrective action
form

1.CAR
Raised
2.CAR
logged
Problem
Solving Team
Corrective and
Preventive
Action Process
3.Investigate root
cause of problem
and identify CA
Major
change ?
Management
Review
4.Implement
CA, Update
documentation
No
5.CA
effective?
Yes
End
1. Raising a Corrective or
Preventive Action

Audits (internal and external)
Observations by staff
 Management review
 Client feedback

2. Recording the CAR
Initiate CAR form
 Record corrective or preventive action

 categorise

Quality Manager to
 log
in CAR
 allocate unique CAR identification number
3.1 Investigating the Corrective
Action

Investigate root cause of the problem
 why

did the problem occur ?
Potential causes:
 samples
 methods
 staff
and procedures
skills and training
 equipment

and calibration
Record CAR
3.2 Identify Possible Corrective
Action

Identify potential corrective action
 what
would prevent the problem from
happening again ?


Problem solving team
 if
many staff or departments affected
 if
major non-conformance
Record on CAR
4. Implement Corrective Action

Implement the action/s
 make
changes to the system

Record

Update documentation
5. Was Corrective Action
Effective ?

Verify and record effectiveness
 has
it prevented the problem from occurring
again ?
 follow up
 additional
audits
Equipment Calibration
Outline

Requirements for calibration

Equipment identification

Calibration and maintenance records

Equipment documentation

Subcontractors

Benefits of calibration and maintenance
Equipment Calibration Required:

By ISO 9000
 clause

4.11.1 and 4.11.2
By ISO/IEC 17025
 clauses
5.5 and 5.6
Requirements of ISO/IEC 17025

Unique number identifying each
piece of equipment

Routinely maintain & calibrate

Document maintenance procedures
 make
them easily accessible
Requirements of ISO/IEC 17025

Measurements traceable to national
measurement standards

Results must be accurate and clear

File all records appropriately
Equipment Identification

Assign unique identification number to
each piece of equipment & reference
material

May be equipment serial number
 OR

number assigned by laboratory
Display identification number on the
equipment in a visible area
Equipment Records &
Maintenance

Maintain records of:
 Equipment
 Date
name, unique number
received, condition upon installation
 Maintenance
history, future maintenance
dates

Service/calibrate equipment &
reference materials at regular intervals
- per NATA specifications
Documentation

Each piece of equipment must have
full documentation of:
 Instructions
for proper use
 Maintenance

procedure
Documentation accessible to all staff
 More
than one copy may be required
Traceability

Calibration of reference material &
test equipment must be traceable to
national measurement standards
Results

As calibration certificate, test report
or test certificate

Accurate and clear
 stating

any measurement uncertainty
Include information necessary for
interpretation of the calibration
Records

Must include:
 which
 who

equipment was calibrated
performed calibration
File records in a safe location
Sub-Contractors

Calibrations by sub-contractors must
also comply as above

Do not assume sub-contractor:

will follow necessary procedures
 is
authorised to calibrate a particular
piece of equipment
Benefits of a Maintenance
System

Ensures that equipment operates within
specifications

Maintains uniformity and quality of testing

Identifies potential problems before they
become major
 Reduces
costs
Preventive Maintenance at NRL

Procedures, Work Instructions
 Document
calibration steps for each
piece of equipment
 List
limitations and acceptability criteria
Preventive Maintenance at NRL

In-house application
 developed
 inventory
of critical equipment
 calibration
 help
in Microsoft Access
histories
identify patterns of non-conformities
 maintenance
 ensures
schedule
no equipment is overlooked
Preventive Maintenance at NRL

Confirmation sticker on each piece
of equipment shows status
 green
sticker- confirmed for use
 within
 red
dates
sticker - decommissioned
 must
not be used
 additional
information
Preventive Maintenance at NRL

Original calibration records & test
results
 filed
by equipment category & unique
identifier
 archived
at end of year
 accessible
for audits
Preventive Maintenance at NRL

Contractors informed of requirements

Where possible yearly contracts are
established and revised to ensure
compliance
Outcomes

Reproducibility in testing

Confidence in equipment

Reduced errors & down-time

Reduced cost of equipment breakdowns & replacements
Management Review
Outline

What is required

What happens

Inputs into the review

Outputs
Management Review Required:

By ISO 9000
 clause

4.1.3
By ISO/IEC 17025
 clause
4.14
Management Review

Review:
 Effectiveness
 Continued
of quality system
suitability
 Resourcing
 Training
 Make
necessary changes
Management Review

Input (Quality Manager’s report):
 External and internal audits
 Corrective
 Customer
and preventive actions
complaints
 Interlaboratory
comparisons
Management Review
Consider impact of any changes in
functions or external environment
 Records must be kept

Management Review

By Whom?
 Senior
management
 People
who can direct change
 Quality
Manager involved
Management Review

NRL approach:
 Review
by Director, Senior Scientist,
Quality Manager (6 times/year)
 Supplemented
 Different
by weekly team meetings
for different organisations
Management Review

General Requirements for
Registration
3.02.3
“The effectiveness of the quality
system shall be reviewed by
management at least once per year.”
Management Review

ISO/IEC 17025 4.14.1
“in accordance with a predetermined
schedule”
“A typical period for conducting a
management review is once every 12
months”
Management Review

Keep changes rational

Integrate with other management
processes where appropriate and
possible
Management Review

Outcomes:
 Minutes
with actions,
responsibilities
 Corrective
action as appropriate
Review of the Aims of the QMS
Section

To clarify the requirements of a Quality
Management System (QMS)
Expected Outcomes of the QMS
Section

Know how to meet the requirements of
ISO/IEC 17025 or ISO 9001 by
implementing a practical, easy to
maintain QMS