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 !!!