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: 00-QA-45 :2 : January 2011

CHANGE MANAGEMENT FORM

Rev No Effective Date

Change Proposal No : Initiation Date Demanded Implementation Date Change Description Reason of Change Initiator Responsible for Change (Dept)

Reference(s)/Breakdown story and Detail Design, Sketch Drawing to be attached if any Supplier/Contractor Manufacturer Supplier Approval Status/Last Audit Material Category/Name of Machine & Sub System Material number (for existing material) Function/Used in product (%-age) Application in IFT product (IF/FOF/GUM) Sample Quantity Way of Application : dry blending blowing into spray dryer/fluid bed wet processing including heating for at least 72C at 15 wet processing with lesser heat treatment Others (to specify) Describe from left column:

Nature of Change, please fill N for New or M for Modification

Supplier Raw material Packaging Material Promotional Items Operating conditions Plant control software Chemical (inc. cleaning chemical) Other (specify) Rental or Co-warehouse Electrical (inc PLC) and Instrument Engineering Contractor Product Specification Co-packers/Co-manufacturers Transport and warehousing Quality, Food Safety, Halal, and Food Security related Intended/consumer use Process formulation and set point Human Safety and Environment Raw/Pack or others Spec Outsourcing Pest Control Contractor Operating or maintenance or cleaning procedures Other (specify) Distribution Utility Mechanical SAP Labeling & Claims Shelf-life Equipment/machine & Production Line

Risk Assessment
Potential Hazard/Risk Yes/ No If YES, specify the Risk Assessment and Control PIC / Due date

QUALITY, FOOD SAFETY, HALAL, FOOD SECURITY risk

1 Relevant food safety, Halal or other legislative standards, product's appearance, taste, aroma, foreign material, damage, contamination, CCP/OPRP, packaging integrity, safety and ease of use by consumer, maintenance of appropriate conditions (temperature, humidity, light, process gases, etc)

HUMAN SAFETY and HEALTH Risk

Noise, dust, heat, lighting, ergonomics, manual handling, PPE, working at heights, confined space, hot work

ENVIRONMENTAL, FIRE and CHEMICAL Risk

3 Dust, smoke, noise, odors, visual impact, waste, effluent, clean-up procedures, license. Flammability, corrosive and toxic effects, unstable reactions and mixtures, disposal of chemicals and empty containers, Flammable chemicals, combustible materials, fire fighting equipment, fire detection, FC requirements

ENGINEERING Risk (MECHANICAL & ELECTRICAL)

Exposure to moving/rotating machinery, use of lifting equipment. Circuits, auto start systems, spark proof, automated systems, isolation, PLC

PROCESS Risk
Pressure, temperature, flow rates, chemical concentrations, exceeding design specs, plant performance, labor/material requirements

STACKING/STORAGE/TRANSPORTATION Risk
6 Use of mobile lifting equipment, storage at heights, pedestrian areas, separation of hazardous materials, forklift activity, storage/access space

BUSINESS Risk
Company reputation, cost, CAPEX investment, overtime, efficiency, reliability, delivery to customer, asset value, software risk

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: 00-QA-45 :2 : January 2011

CHANGE MANAGEMENT FORM

Rev No Effective Date

Clearance Checklist (Please for the document needed)

Document Applicable Yes No PIC Due Date Document EXTERNAL (SUPPLIER, VENDOR, 3 Certificate of Analysis Material Specification Contaminant Declaration Major Allergen Declaration GMO Declaration Migration Test Supplier Questionnaire Service Level Agreement for InterCompany MSDS Audit Report LOGISTIC (STACKING/STORAGE/TRANPORTATION/DISTRIBUTION) Distribution Packaging and Transportation Test Applicable Yes
rd

No

PIC

Due Date

QUALITY, FOOD SAFETY, HALAL, AND FOOD SECURITY Approval letter QA & RD for IFT FrieslandCampina Standards Codex/FAO/WHO/European Standards Label/Artwork Design Patent/Claim Registration SNI BPOM (MD Number) Permenkes/Dinkes/Badan Karantina/PP Halal Certificate ISO Certificate EHEDG Technical Buying Spec HACCP (CCP, OPRP) R&D Trial Report (Reproducibility) QC Lab Analysis Report QCP Shelf Life & Keeping Sample Test PROCESS Formula/Recipe/Matrix Internal Specification (Material, Process, Product) Operating Manual (SOP/WI/COP) Validation/Modification Report Rework/Reprocess Management Evaluation 1 OTHERS
st

PARTY, INTER-COMPANY)

ENGINEERING
Preventive Maintenance Schedule Spare part & Instrument Calibration FMECA Assessment HUMAN SAFETY AND HEALTH HAZOP and OH&S Safety Interlock LOTO BUSINESS RISK Site Master File Supplier List & Qualification Registration SAP Material Number (Raw, Packaging, Intermediate, BOM)

Commercial Run

Remarks :

REQUIREMENT (Please put if required) Consulted with CCB and related function are performed Need Internal or External Communication Need for Training / Operating Instructions Need for Apply for or Alter Licences

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: 00-QA-45 :2 : January 2011

CHANGE MANAGEMENT FORM

Rev No Effective Date

CHANGE APPROVAL, please fill Consult (C) or Inform (I) C/I Position Sign and Date C/I Position QA Mgrs Plant Mgr Supply Chain Mgr Corp R&D Mgr Corp Procurement Mgr Corp WH Mgr DT
Others

Sign and Date

Prepared By

QC Mgr Engineering Mgr

Sign and date

Project Mgr PPIC Mgr RA Mgr

Approved By

Sign and date

Trade Marketing Mgr Marketing Mgr

Others

Acknowledged By

Sign and date

Remarks :

HAND OVER From (Initator):

Remarks :

Name

Sign and date

To (User):

Name

Sign and date

CHANGE REVIEW Reviewed By Date of Review

Sign and date

Remarks (before and after change) :