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AWARENESS & APPLICATION FOR INTEGRATED MANAGEMENT SYSTEM

ISO 9001:2015 & FSSC 22000 VER. 5.1

Tutor : Mr. Nguyen Dai Hiep


Food Lead Tutor/ Auditor
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Valuation and Confidence

Chapter 3: Overview PRP- ISO/TS 22002-1 and added


requirements from FSSC

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ISO/TS 22002-1 Requirements
Contents of ISO/TS 22002-1
► § 1 Scope
► § 2 Normative reference
► § 3 Terms & definitions
► § 4 Construction and layout of buildings
► § 5 Layout of premises and workspace
► § 6 Utilities – air, water, energy
► § 7 Waste disposal
REQUIREMENTS

► § 8 Equipment suitability, cleaning and maintenance


► § 9 Management of purchased materials
► § 10 Measures for prevention of cross contamination
► § 11 Cleaning and sanitizing
► § 12 Pest control
► § 13 Personnel hygiene and employee facilities
► § 14 Rework
► § 15 Product recall procedure
► § 16 Warehousing
► § 17 Product information / consumer awareness
► § 18 Food defence, biovigilance and bioterrorism
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ISO/TS 22002-1 Requirements

Terms & definitions


► ISO 22000 § 3 applies with some extra terms

► Codex Alimentarius used as a guidance for definitions

► § 3.2 contaminant: is not intentionally added to food;


another PAS (# 96) is dealing food defence. But see § 18
► § 3.4 materials: not only raw material but also for
packaging, process aids, cleaning chemical and
lubricants
► § 3.12 sanitizing = cleaning + disinfection
► § 3.15 zoning: taking into account microbiological cross-
contamination to define & segregate areas
► § 3.18 & 3.19: FEFO ≠ FIFO
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ISO/TS 22002-1 Requirements

Foreword
► Shall = must

► Should = recommendation

► NOTE = is not compulsory (same as ISO 22000)

► Usually, each chapter begins with a “statement of intent”


(as BRC standards) explaining the main objectives of the
requirement – General Requirements

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ISO/TS 22002-1 Requirements

4 Construction and layout of buildings


► 4.1 What to do if buildings are old, haven’t been designed for the
current purpose but some adequate improvement & fixing have been
implemented?
► 4.2

 Give example of possible contamination from the local environment.


 Give some examples of control measure against above
contamination?
 What is the appropriate frequency for reviewing the effectiveness of
these control measures?
 How to keep record that consideration has been given about this
issue?
► 4.3 How to control access to the site?

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ISO/TS 22002-1 Requirements
5 Layout of premises and workspace
► 5.1 How to assess this clause?

► 5.2 If physical separation is not possible due to lack of space,


but a time “separation” is implemented, is it compliant?
► 5.3

 What to do as an auditor if wall floor junction are not


rounded?
 What to do as an auditor if some water is remaining on the
production workshop?
 Is it possible to open external windows during manufacturing
hours?
► 5.4 What is the appropriate distance between an equipment and
the walls?
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ISO/TS 22002-1 Requirements


5 Layout of premises and workspace (cont’d)
► 5.5

 Is on-line temperature checks with a glass thermometer OK?


 If the laboratory is not testing for pathogenic micro-organisms but
only Total count shall it still be separated from production area?
► 5.6 What kind of additional hazards can be associated with vending
machines?
► 5.7

 How often to monitor temperature & humidity?


 No pallets along the walls!
 Is it possible to store grain directly on the floor?

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ISO/TS 22002-1 Requirements

6 Utilities – air, water, energy


► 6.1

 Minimizing contamination
 Beware of leaks, dirty pipes over products…
 Utilities not to contaminate the product (ex: oil-free compressed air)
► 6.2

 Potable water: according to WHO & local regulation


 Is it sufficient to provide a water analysis coming from municipal
network?
 How often testing water for microbiological & chemical criteria?
 Water chlorination to be closely monitored at the point of use

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ISO/TS 22002-1 Requirements

6 Utilities – air, water, energy cont’d


► 6.3 “Approved food additives” boiler chemical to be used

► 6.4

 Provide examples of air used as an ingredient


 Is microbiological analysis of air demanded in every cases?
 How often testing air for microbiology?
 Provide examples where air temperature / humidity is critical
 Are positive air pressure system compulsory?
 Air filtration system to be included in cleaning & preventive
maintenance schedule
 How to periodically inspect exterior air intake ports?

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ISO/TS 22002-1 Requirements

6 Utilities – air, water, energy cont’d


► 6.5
 “Food grade” gases (NO2, CO2)
 Compressed air to be filtered & with oil remove system
 Shall all compressors be using “food grade” oil?

► 6.6
 Where to protect lighting in case of breakage?
 How to protect lighting in case of breakage?

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ISO/TS 22002-1 Requirements

7 Waste disposal
► 7.1 Statement of intent: prevent contamination

► 7.2

 Dedicated containers for waste, hazardous substances


 Containers to be clearly identified closed/ locked

► 7.3

 How often to remove waste?


 Is it forbidden to have a waste bin in production area?
 Why this clause about trademark destruction to be recorded?

► 7.4

 Why drain shall not pass over production line?


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ISO/TS 22002-1 Requirements

8 Equipment suitability, cleaning & maintenance


► 8.1 Statement of intent: no contamination & easy to clean

► 8.2 Principles of equipment hygienic design


(ISO 14159:2002)
► 8.3

 What shall an auditor be asking to check that product contact surfaces are
of “food grade”?
 How to ensure that equipment prior 2004 is suitable for food?
► 8.4

 Provide examples of equipment used for thermal processes


 ≈ process or equipment validation

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ISO/TS 22002-1 Requirements


8 Equipment suitability, cleaning & maintenance (cont’d)
► 8.5

 What shall be mentioned on a documented cleaning programme?


 Don’t forget utensils, air filtration / cooling equipment
 Is verification of cleanliness compulsory?
 How to verify effectiveness of the cleaning?
► 8.6

 Corrective maintenance not sufficient: preventive is demanded!


 How to avoid contamination during maintenance operations?
 Beware of temporary repairs (tape…) & lubricants
 Positive release of equipment after repair is demanded & to be recorded
 Maintenance personnel to be trained on relevant food safety hazards

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ISO/TS 22002-1 Requirements
9 Management of purchased material
► 9.1 Statement of intent: ensure supplier capability to provide safe material
& verify purchased material is safe
► 9.2

 ≈ ISO 9001 but focusing on food safety, based on hazard assessment


 Is auditing of suppliers compulsory?
 Provide example of performance criteria to be defined & followed?
► 9.3

 Prior unloading checks


 How often to test incoming materials?
 Why access points to bulk material must be locked?

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ISO/TS 22002-1 Requirements

10 Measures for prevention of cross contamination


► 10.1 Statement of intent & scope

► 10.2

 Zoning to be defined & implemented using hazard analysis


 Beware of movement of personnel, waste, utilities and tools
 In which case as an auditor you would demand for a positive air pressure
system?
► 10.3

 Which allergens shall be considered? Declared?


 Rework to be closely assessed
 Personnel handling allergens to be trained

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ISO/TS 22002-1 Requirements

10 Measures for prevention of cross contamination (cont’d)

► 10.4
 How often to inspect glass & hard plastic material?
 Why recording glass breakage?
 Specific attention to be paid on: screens, magnets, sieves, filters,
metal detector, wooden pallets, protective clothing…

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ISO/TS 22002-1 Requirements

11 Cleaning and sanitizing


► 11.1 Statement of intent: establish and monitor programmes

► 11.2

 “Food grade” cleaning chemical to be used


 Cleaning equipment and utensils to be in good repair
► 11.3

 How to validate cleaning & sanitizing programmes?


 Are post-cleaning & pre start-up inspections compulsory?
► 11.4 CIP to be monitored

► 11.5 How to check sanitation effectiveness? How often?

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ISO/TS 22002-1 Requirements

12 Pest control
► 12.1 Statement of intent

► 12.2

 Mr. Pest to be nominated


 What to mention in pest control programmes?
 List of chemicals and there approval.
 Are poisonous baits forbidden in production area?
► 12.3 To prevent pest ingress: no holes, sealed drains, screened windows,
proof fit doors…
► 12.4 Implement good storage practices

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ISO/TS 22002-1 Requirements

12 Pest control (cont’d)


► 12.5

 Updated map of baits including fly killers


 How often to inspect baits?
 Records shall be analyzed - trends
 If sub-contracted all requirements still apply
► 12.6

 Use and application restrict to trained operatives


 Pesticide to be approved as can be used in food processing area
 Comprehensive records to be maintained

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ISO/TS 22002-1 Requirements

13 Personnel hygiene and employee facilities


► 13.1 Statement of intent: document appropriate requirements to personnel, visitors
(auditors…) & contractors
► 13.2

 In which cases, is hand sanitizing required?


 Supply of cold and hot water or temperature controlled
 Toilets shall not open directly on to production, packaging or storage areas
► 13.3

 Canteen and designated areas shall not bring contamination to product


 Hygienic storage, cooking and holding temperatures

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ISO/TS 22002-1 Requirements

13 Personnel hygiene and employee facilities (cont’d)


► 13.4

 Workwear in good conditions


 No buttons, no pockets above waist
 What is the appropriate interval for laundry?
 Is home laundry acceptable?
 Hair but also beards & moustaches to be contained
 Look at the shoes
► 13.5

 Medical screening required prior to employment


 What is the appropriate frequency for on-going medical screening?

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ISO/TS 22002-1 Requirements

13 Personnel hygiene and employee facilities (cont’d)


► 13.6

 List of illnesses / symptoms


 Wounds preferably covered by dressings (colored and metal detectable)
 Also applies to visitors & contractors
► 13.7 Detailed requirements for personnel cleanliness

► 13.8

 Documented Policy
 Jewellery to be considered as a hazard
 False nails & nail polish forbidden
 Look at what’s inside personal locker and above!

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ISO/TS 22002-1 Requirements

14 Rework
► 14.1 Statement of intent: rework shall not jeopardize product safety, quality, legality
and traceability
► 14.2 Rework to be

 Adequately stored & labeled


 Recorded to maintain traceability
► 14.3

 Reworking rule to be defined: recipe A in recipe B, shelf life, storage conditions…


and mentioned on flow diagram
 Reworking rules to be validated: shelf life, labelling of finished products
 Prevent contamination if unpacking step

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ISO/TS 22002-1 Requirements

15 Product recall procedures


► 15.1 Statement of intent: being able to identify, locate and remove all
unsafe/non conforming product along the supply chain
► 15.2

 Detailed procedure including key contacts


 Who are the key contacts in case of product recall?
 Consider public warning
 Consider products manufactured according to similar conditions

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ISO/TS 22002-1 Requirements

16 Warehousing
► 16.1 Statement of intent: storage conditions shall not contaminate products

► 16.2

 How often to monitor storage conditions (temperature / humidity)?


 Non conforming products to be segregated
 FEFO or FIFO system to be implemented
 Use of diesel or gasoline powered fork lift trucks forbidden everywhere?
► 16.3

 Is permanent recording of vehicles temperature compulsory?


 Beware of bulk transportation – Food use only

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ISO/TS 22002-1 Requirements

17 Product information and consumer awareness


► Information shall be present in a way that the consumer to choose products with full
knowledge of relevant information
► Information can be provided by labeling, websites and ads

 Relevant allergens mentioned?


 Shelf life mentioned?
 Batch number mentioned?
 Appropriate language?
 Conditions of use described?
 Customer care contact mentioned? Preparation and serving
 Any other relevant data…

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ISO/TS 22002-1 Requirements

18 Food defence, biovigilance and bioterrorism


► 18.1

 Intentional contamination shall be considered during hazard analysis


 Protective measure to be implemented accordingly (tamper evident packaging,
locked silos, personnel background screening…)
► 18.2

 What are the sensitive areas?


 How to control access?
 If external doors are kept open?

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Additional Requirements by FSSC 22000 Ver 5.1
Refer to 2.5 of FSSC 22000 Scheme version 5.1

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Additional Requirements, Ver 5.1

►The additional Scheme requirements are: Refer part 2, 2.5


2.5.1) Management of services and purchased materials {a,b,c,d}
2.5.2) Product labelling,
2.5.3) Food defense,
2.5.4) Food fraud mitigation,
2.5.5) Logo use,
2.5.6) Management of allergens (for categories C, I and K only),
2.5.7) Environmental monitoring (for categories C, I and K only),
2.5.10) Storage and warehousing
2.5.12) PRP verification.
2.5.13) Product development

Are you available for these in your factory?


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HOW TO APPLY FOOD SAFETY CULTURE

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I HOW TO APPLY FOOD SAFETY CULTURE

1. Plan and implemet internal audit ( Ref. audit checklist for food safety culture)….>>>
making audit report

2. Survey 1- Gerenal questions to all employees


3. Survey 2- Awereness questions for quality and food safey to leaders, supervisors,
technical man, QA/QC
….>>>> making the report base on comparision with annex of food safety guide….>>>
comments and suggestions for improving human resource

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