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    Change Management Form-Rev2-200111

    Uploaded by

    MIEKA89
    This document is a change management form used to propose, review, approve, and implement changes at a company. It summarizes a proposed change, assesses potential risks, and requires sign off from various functions like quality, engineering, supply chain and others. If approved, it outlines handover of the change from the initiator to the user and later reviews to assess the impact of the change. The form aims to ensure all changes are properly evaluated, approved and documented.

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    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd

    Change Management Form-Rev2-200111

    Uploaded by

    MIEKA89
    314 views3 pages
    This document is a change management form used to propose, review, approve, and implement changes at a company. It summarizes a proposed change, assesses potential risks, and requires sign off from various functions like quality, engineering, supply chain and others. If approved, it outlines handover of the change from the initiator to the user and later reviews to assess the impact of the change. The form aims to ensure all changes are properly evaluated, approved and documented.

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    Original Title

    Copy of Change Management Form-Rev2-200111[1]

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    © Attribution Non-Commercial (BY-NC)

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    This document is a change management form used to propose, review, approve, and implement changes at a company. It summarizes a proposed change, assesses potential risks, and requires sign off from various functions like quality, engineering, supply chain and others. If approved, it outlines handover of the change from the initiator to the user and later reviews to assess the impact of the change. The form aims to ensure all changes are properly evaluated, approved and documented.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    314 views3 pages

    Change Management Form-Rev2-200111

    Uploaded by

    MIEKA89
    This document is a change management form used to propose, review, approve, and implement changes at a company. It summarizes a proposed change, assesses potential risks, and requires sign off from various functions like quality, engineering, supply chain and others. If approved, it outlines handover of the change from the initiator to the user and later reviews to assess the impact of the change. The form aims to ensure all changes are properly evaluated, approved and documented.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
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    The document discusses a change management form that is used to document and get approval for any changes made to processes, materials, equipment, etc. within the company.

    The change management form is used to propose, document, get approval and review changes made within the company. It captures details of the proposed change, risk assessment, clearance requirements and sign-offs from relevant departments.

    In the change description section, details like change type (new or modification), materials/equipment involved, reason for change, specifications, drawings etc need to be provided to describe the proposed change.

    Doc No

    : 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

    Doc No

    : 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

    Doc No

    : 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) :

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