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Quality and Food Safety Audits

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					Quality and Food Safety
         Audits
An auditee perspective of quality and food
  safety audits in a changing world and
      some valuable lessons learnt.
       Purpose of QMS Audit

• Provide an external verification of the extent
  to which your QMS complies with the
  standards of ISO 9001:2000, in order to
  identify areas of risks and to provide a basis
  for continuous improvement.
Types and frequency of audits
Type of Audit                 Frequency                        Agency
QMS Certification Audit       3 years                          SABS/DEKRA/SGS/TUV
QMS Surveillance Audit        1 year                           SABS/DEKRA/SGS/TUV
QMS Audits Internal           Audit Schedule e.g. monthly      Internal Auditors
OSHAS 18001 Internal          6 months                         SHEQ Internal
OSHAS 18001 External          1 per year                       NOSA
Good Manufacturing Practice   Monthly                          Internal
Supplier Audit (Customer)     1 per year                       Customer Representatives
Supplier Audit (Supplier)     1 per year (or needs analysis)   SHEQ Representatives
Ethical Audit                 1 per year                       Third Party or Customer Rep
             The Big Six

•   Document Control
•   Record Control
•   Internal Audits
•   Non Conformances
•   Corrective Action
•   Preventive Action
               Supplier Audit Score Card
                                               Y/N   Score
Quality Management System
  Does the Company hold an accredited system    Y     3


Quality Manual
 Quality Manual Statement                       Y     3
Equipment Design and Maintenance
  Scheduled plant maintenance                   Y     3
Plant Hygiene & Housekeeping
  Work Instructions                             Y     2
Pest Control
  Documented Pest Control Programme             Y     3
Score Card
0 = No evidence seen . System Required
1= Some evidence, need for system review
2= System in place but requires improvement
3= Acceptable standard
                    The Audit Matrix
SANS Requirements            Code    Mgt   Mkt   Dist   Pack Maint Lab

Document Requirements        4.2      X

Control of Documents         4.2.3    X     X      X     X     X    X

Control of Quality Records   4.2.4    X     X      X     X     X    X

Management Commitment        5.1      X

Quality Policy               5.3      X

Infrastructure               6.3            X      X     X     X    X

Work Environment             6.4            X      X     X     X    X

Customer Related Processes   7.2            X      X

Monitoring & Measurement     8.2      X

Internal Audit               8.2.2    X

Analysis Of Data             8.4      X

Corrective Action            8.5.2    X     X      X     X     X    X

Preventive Action            8.5.3    X     X      X     X     X    X
     Report against standards
No   Criteria
01   Design and Construction of Premises
     Roads and parking areas are well maintained
02   Foreign Body Control – Glass and Hard Plastics Monitoring
     A glass and hard plastic register is in place
     All checklists were up to date
03   Foreign Body Control - Metal
     Rare earth magnets on all lines functioning satisfactorily
     Weekly checklist reviewed – reduction in metal weighed from 200 to 13 grams
04   Organisation and Management of Cleaning
     Basic cleaning schedules in place for cleaning activities
     Cleaning schedules required for all new areas and to include engineering experience required
05   Pest Prevention
     A wasp nest was found inside the packaging area.
     Agreed to implement a cockroach monitoring procedure
06   Personal Hygiene
     A formalised personal hygiene policy is in place
     Copy to be displayed inside the refinery and Packing area before 01 May 09
07   Self Auditing – Corrective Actions
     All non conformances are not adequately followed up and signed off. Implement s/o system by March 09

08   Staff Amenities
     Audit Satisfactory
09   Training
     Induction Training is in place
10   Process Control
     Audit Satisfactory. Production scales calibrated on annual basis by SASCO . Certificates reviewed.
                          Supplier Audit Score Card
                                                      Y/N   Score
Quality Management System
  Does the Company hold an accredited system           Y     3


Quality Manual
 Quality Manual Statement                              Y     3
Equipment Design and Maintenance
  Scheduled plant maintenance                          Y     3
Plant Hygiene & Housekeeping
  Work Instructions                                    Y     2
Pest Control
  Documented Pest Control Programme                    Y     3

  Score Card
  0 = No evidence seen . System Required
  1= Some evidence, need for system review
  2= System in place but requires improvement
  3= Acceptable standard
                    Internal Audit Report

Inspection of Facilities                Good   Average Poor


Factory Structure                                X
Factory Surrounds                                X
Hygiene & Housekeeping                           X
Process Control                           X
Finished Product Control (Not Tested)
    Compliance to Code of Practice
Serial        Compliance to Code of Good                     N/A Yes No
 No                    Practice
     1   Access and Signage                                            X
     2   Availability of Procedures and Work Instructions              X
     3   Hand Washing Stations                                         X
     4   Adequate Lighting                                             X
     5   Adequate ventilation                                          X
     6   Adequate waste removal facilities                             X
     7   Proper drainage                                               X
     8   Designated smoking areas                                             X
     9   Metal Detection (Magnets)                                            X
    10   Glass breakage procedures (not implemented)                          X




No        Deviation/Observation                              Responsibility
1         Packing area fluorescent tube not shielded         Plant Manager

2         Packing material store converted to a scrap yard   Safety Officer
              Types of Reports

•   Quality System Assessment/Audit Findings Report
•   Supplier Inspection Report
•   Quality System Audit Plan Matrix
•   Pre Audit Questionnaire
•   Audit Report
•   E mail communication
•   Faxed Reports
•   Customer Complaints
       Follow Up Action Points
No   Action Points                                Timescale
1    Ensure that all inspection checks are signed   Immediate
     off with detail as having been carried out and
     not left blank
2    Increase frequency of checking metal         3 months
     detector to start and end of shift
3    Some documentation did not show control      3 months
     document details
                  Quality System Assessment
                    /Audit Findings Report


Serial   Description of   Name and Signature of       Clause   Rectification
No       Finding          Supplier’s representative            Date
Quality Improvements Register

•   Graphs
•   Pareto Charts
•   Eye ball statistics
•   Photographs
•   Capital Expenditure
•   Customer Feedback
•   Growth of Business
What you see is what you get !!!

Plant Audits        Document Control
What you see is what you get !!!

Non Conforming Product   Training
               OSHAS Audits

Housekeeping         OSHAS 18001
        Internal Auditing
Comparing Notes      Smiles all round
          ISO 14001 Audits
Satisfied Customer    ISO 14001 Audit
    Ethical Audits
Procedure    Health and Welfare
       The Informal Sector
Farm to Table    Informal Markets
Opportunities for Improvement

• Delay in submission of final audit reports
• Politeness barrier when dealing with Senior
  Management
• Some auditors too lenient (set companies up
  for failure)
Follow Up Action Points
 No   Action Points                                    Timescale
 1    Ensure that all inspection checks are signed     Immediate
      off with detail as having been carried out and
      not left blank
 2    Increase frequency of checking metal             3 months
      detector to start and end of shift
 3    Some documentation did not show control          3 months
      document details
          Audit for Improvement
•   Capital Expenditure
•   Training and Awareness
•   Business Improvement
•   Staff Morale
•   Improved Customer Satisfaction
•   Less scrap and rework
•   Business Performance (Customers, share
    value etc)
                 Cost of Audits

•   Travel
•   Accommodation
•   Freebees
•   Service Cost
•   Management Time
•   Quality Assurance Costs
•   Employee Time
           Corrective Action (Auditor)

• Lack of consistency in interpretation of ISO standards
• Old Boys Club to be more flexible to changes
• Use financial terms to get management to take notice of
  your quality message
• Identify and understand various types of costs and their
  impact on margins.
• Use simple financial calculations to perform basic cost
  analysis.
       Corrective Action (Auditee)


• Demonstrate that you are implementing that program.
• Willingness to learn new methods
• Don’t only focus on trying to understand what the auditor is
  looking for to pass the test.
• Understand the real objective of audits.
• Not all documentation is necessary to demonstrate that you
  are following Good Manufacturing Practices.
The Real Cost of Quality

•   Reprocessing
•   Expediting
•   Unplanned Service
•   Inventory
•   Customer Complaints
•   Downtime
                         Costs of Audits
                               Cost To Company        Service Provider
Spar                                      ?      Own Microbiologist
Pick & Pay                                ?      Outside Agency
Woolworths                                ?      Outside Agency
Cash and Carry                            ?      Own Agents
Kosher                                    ?      Kashrut Department
Halal                                     ?      Halal Council
ISO 9001 Certification                    ?      Independent Third Party
ISO 9001 Surveillance                     ?      Independent Third Party
HACCP Audits                              ?      Independent Third Party
OSHAS 18001                               ?      NOSA
ISO 14001                                 ?      Independent Third Party
Risk Management                           ?      Independent Third Party
                          =(?+?+?.....)
Reality Check - Phillip Crosby

                     Quotes
 • "Quality is free.
   It’s not a gift, but it’s free.
   The ‘unquality’ things are what cost money."
   -- Philip B. Crosby
   Crosby’s 14 Steps To Improvement
 • I have yet to attend a quality meeting where
   someone didn’t comment to me that they had
   been unable to really reach their management or
   get the people motivated to put quality
   improvement over the top.
Thank You !!!

				
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