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Multi-Site Management System Implementation
Managing from Afar
Develop a visit strategy
Set expectations for work completed
Define “work complete”
Detailed plans
Routine updates
S...
Hands On Approach
1. Engagement, Planning, & Initial Start
2. Requirements Review
3. Business Process Training
4. CA/PA &...
5 Phases
1. Leadership focus
2. High level & department processes
3. System processes
4. Verification and validation
5. S...
Item Description
%Complete
Owner
Status
Start
Complete
Target
4/21/2015
4/28/2015
5/5/2015
5/12/2015
5/19/2015
5/26/2015
6...
Certification Date Phase 1 Responsibility Date Due Status
Develop Plan
Senior Leadership Training
Resource Allocation
Requ...
ISO 22000, ISO 9001, ISO 14001, & OHSAS 18001 Approach/Process Records/Evidence Notes
4 Management System
4.1 General requ...
ID Clause Requirement
Processes used to control
Requirement
Verification
Activity
Frequency
Evidence
Record
FST Verificati...
#
ID'd
From
Date
Open
Area Item Name Category Sub-Category Item Description Owner Date Due Date Closed
12038 G Mar-12 Qual...
Jules Fijux, MBA
ASQ Certified Manager of Quality / OE
jfijux@gmail.com
Multisite Project Management
Multisite Project Management
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Multisite Project Management

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Multisite Project Management

  1. 1. Multi-Site Management System Implementation Managing from Afar
  2. 2. Develop a visit strategy Set expectations for work completed Define “work complete” Detailed plans Routine updates Summary reports Roll-up Summary tracker • Complete system look Have complete sets of tools for training
  3. 3. Hands On Approach 1. Engagement, Planning, & Initial Start 2. Requirements Review 3. Business Process Training 4. CA/PA & HACCP Process Training 5. Operational Controls / GMP Training 6. Process Audit Training 7. Data/Results Analysis Training 8. Pre-assessment / Corrections Plan
  4. 4. 5 Phases 1. Leadership focus 2. High level & department processes 3. System processes 4. Verification and validation 5. Structural issues  Summary Tracker • Leadership summary • Roll-ups all projects
  5. 5. Item Description %Complete Owner Status Start Complete Target 4/21/2015 4/28/2015 5/5/2015 5/12/2015 5/19/2015 5/26/2015 6/2/2015 6/9/2015 6/16/2015 6/23/2015 6/30/2015 7/7/2015 7/14/2015 7/21/2015 7/28/2015 8/4/2015 Total Projected Implementation Sat, 1/00/00 Sat, 1/00/00 1 Phase 1 Senior Leadership Training 0% Management System Intro Training for Senior Leaders Resource Allocation 0% Identify Food Safey Team Leader / Management Rep Identify Envirnomental Management System Rep Identify OHSAS Management System Rep Responsibility Matrix Organization Chart Skill Sets / Job Descriptions Requirements Training 0% ISO Requirements Training Management Rep ISO Requirements Training Staff PAS Requirements Training Management Rep PAS Requirements Training Staff General Workforce Communication Gap Assessments 0% Gap Assessment (Management System) Gap Assessment (PAS/Operational Controls) Process Flow 0% Process Flow Inventory Current Documents Stage 1 Processes 0% Establish Management Review (Project Review) Management Policy Statement Document & Record Control Processes (SOP) Training Process (SOP) Action Item Log Process Verification Planning 0% PRP Verification Plan (Work Aid) First Draft PRP Verification Plan (Work Aid) FST Review 2 Phase 2 Risk Assessment Training 0% HACCP Training Risk Assessment & Business Plan Training Perform Risk Assessments 0% PRP Risk Assessment HACCP Analysis Business & Quality Assessment Environmental Aspects & Impacts Safety Risk Assessment
  6. 6. Certification Date Phase 1 Responsibility Date Due Status Develop Plan Senior Leadership Training Resource Allocation Requirements Training Team Names Signatures Gap Assessments Sponsor: Process Flow Lead: Stage 1 Processes Member: Verification Planning Member: Summary 0% Member: Member: Phase 2 Responsibility Date Due Status RTM: Risk Assessment Training MSM: Perform Risk Assessments Business Planning & Management Review Food Safety Processes Status Item Expected Cost Environmental Processes OHSAS Processes Production Work QA/Lab Work Warehouse Work Maintenance Work Summary 0% Phase 3 Responsibility Date Due Status Management System Process Training Management System Processes Business System Processes Maintenance System Processes Management System Verification Summary 0% Phase 4 Responsibility Date Due Status Analysis of Verification Results Actions From Analysis #DIV/0! Summary -$ How to use a Management System Training Preassessment Corrections from Preassessment Certification Attendees Summary 0% Roadblocks Next Steps Next Visit Comments Project Status #DIV/0! Date Last Reviewed Facility Name Current Plant Status Plan Goal Operational Controls & PAS Required Corrections
  7. 7. ISO 22000, ISO 9001, ISO 14001, & OHSAS 18001 Approach/Process Records/Evidence Notes 4 Management System 4.1 General requirements ISO 22000 § 4.1 ISO 9001 § 4.1 ISO 14001 § 4.1 OHSAS 18001 § 4.1 The organization shall establish, document, implement and maintain and continually improve an effective management system, which includes quality, food safety, environmental and safety management. The management system shall be updated when necessary in accordance with the requirements of the International Standards of ISO 22000, ISO/TS 22002-1, ISO 9001:2008, ISO 18001:2007, and OHSAS 14001:2004, and shall determine how it will fulfill these requirements. Management System Manual Manual Master Document List Records / Records List Management Review The organization shall define and document the scope of its management system for quality, environmental, and safety. Management System Manual Section 2 of Manual - Scope The organization shall define the scope of the food safety management system. The food safety scope shall specify the products or product categories, processes and production sites that are addressed by the food safety portion of the management system. Management System Manual Section 2 of Manual - Scope
  8. 8. ID Clause Requirement Processes used to control Requirement Verification Activity Frequency Evidence Record FST Verification Method 1 4 Construction and layout of buildings 4.1 General requirements Buildings are designed, constructed and maintained in a manner appropriate to the nature of the processing operations that are carried out, the food safety hazards associated with those operations, and the potential sources of contamination from the plant environs. Buildings are of durable construction which presents no During normal management routines items are identified and corrected GMP Inspection Monthly GMP Record Food Safety Coordinator Review 2 4.2 Environment Consideration is given to potential sources of contamination from the local environment. During the annual risk assessment process, FST will perform a PRP Risk Assessment to identify changes PRP Risk Assessment Annually Assessment FST Approval 3 4.2 Environment Food production is not carried out in areas where potentially harmful substances could enter the product During the annual risk assessment process, FST will perform a PRP Risk Assessment to identify changes PRP Risk Assessment Annually Assessment FST Approval 4 4.2 Environment The effectiveness of measures taken to protect against potential contaminants are periodically reviewed. During the PRP Risk Assessment Process, the controls are rated and rerated as needed PRP Risk Assessment Annually Assessment FST Approval 5 4.3 Locations of establishments The site boundaries are clearly identified. Curb, RR Tracks, Outer Walls, Map GMP Inspection Monthly GMP Record Food Safety Coordinator Review 6 4.3 Locations of establishments Access to the site is controlled. Locked doors, gates, e-cards, receptionist GMP Inspection Monthly GMP Record Food Safety Coordinator Review 7 4.3 Locations of establishments The site is maintained in good order. Vegetation is tended or removed. Roads, yards and parking areas are drained to prevent standing water and are maintained. Vegetation is maintained by interal persons Standing water issues are identified during normal management routines and action items are discussed and corrected GMP Inspection Monthly GMP Record Food Safety Coordinator Review
  9. 9. # ID'd From Date Open Area Item Name Category Sub-Category Item Description Owner Date Due Date Closed 12038 G Mar-12 Quality Bev QC lab Building Materials Ceiling Tiles replace soiled ceiling tiles Steve 4/20/2012 5/11/2012 12016 A Mar-12 Production Floor around can line Building Materials Floors worn down to aggregate Steve 4/15/2012 5/1/2012 12024 G Mar-12 Sugar Room Floor needs repaired Building Materials Floors Sugar Room Steve 12/31/201 2 5/9/2012 12039 G Mar-12 Quality Micro lab Building Materials Lights replace cracked light cover Steve 4/20/2012 5/11/2012 12023 G Mar-12 Warehouse Spot Light Out Building Materials Lights No Dock door #8 Steve 4/20/2012 5/11/2012 12017 A Mar-12 Maintenance Drain cleaning. Documentation Missing no documentation for how to clean and verification Randy 4/15/2012 5/11/2012 12018 A Mar-12 Maintenance Maintenance records Documentation No Records no doc rec for release equip from Maint to prod Joe 4/15/2012 5/11/12 12033 G Mar-12 Premix Premix NW corner stand Equipment Needs Replacing replace rusty stand with stainless/aluminum Steve 4/20/2012 4/12/2012 12011 A Mar-12 KOCON Syrup on ceiling Housekeeping Ceiling Tiles KOCON room Randy 4/7/2012 3/27/2012 12031 G Mar-12 Premix Premix fan Housekeeping Fans south fan needs cleaning Steve 4/20/2012 4/12/2012 12034 G Mar-12 Packaging btl line video jet Housekeeping Not Clean clean ink from around the reflector Steve 4/20/2012 12037 G Mar-12 Packaging can line traymore Housekeeping Not Clean ink stain on floor and railing around coder Steve 4/20/2012 12022 G Mar-12 Warehouse North Dock debris Housekeeping Not Clean Doors #1, 2, 3 Steve 4/20/2012 3/27/2012 12036 G Mar-12 Filler Room Can filler/seamer Housekeeping Panels tile SW corner by elec panel needs cleaning Randy 4/20/2012 4/12/2012 12030 G Mar-12 Production Sledge Blow off panel Housekeeping Panels needs cleaned Randy 4/20/2012 3/27/2012 12019 G Mar-12 KOCON KOCON room Housekeeping Piping pipe above coke tank needs cleaning Randy 4/20/2012 4/5/12 12035 G Mar-12 Packaging case washer Housekeeping Piping white exhaust pipes need to be wiped off Steve 4/20/2012 5/11/2012 12021 G Mar-12 Warehouse Area below roll down rack Housekeeping Racks Needs to be cleaned Steve 4/20/2012 3/27/2012 12025 G Mar-12 Water Treatment RO Softener Housekeeping Tanks/Covers salt tank top is dirty Steve 4/20/2012 3/27/2012 12026 G Mar-12 Water Treatment West Water tmt covers & top Housekeeping Tanks/Covers all need cleaning Randy 4/20/2012 12027 G Mar-12 Water Treatment Ferric Sulfate container Housekeeping Tanks/Covers container and area around it need cleaning Steve 4/20/2012 5/3/2012 12028 G Mar-12 Water Treatment East Water Tmt Housekeeping Tanks/Covers Sand filters tops need cleaning Randy 4/20/2012 4/12/2012 12029 G Mar-12 Water Treatment Lime tank, east water Housekeeping Tanks/Covers top needs scraped…lime build-up Randy 4/20/2012 4/12/2012 12032 G Mar-12 Premix Premix filling area Housekeeping Walls false wall needs cleaning; handprint Steve 4/20/2012 3/27/2012 12015 A Mar-12 Premix Eye wash bottles in premix Materials Containers Not Controlled sitting on top of cabinet…need a rack/holder Joe 4/7/2012 3/27/2012 12014 A Mar-12 Can Crushing Wrongly labeled spray bottles Materials Containers Not ID'd Can crushing room Steve 4/7/2012 3/27/2012 12012 A Mar-12 Production Oil drain jug not labeled Materials Containers Not ID'd Alvey Steve 4/7/2012 3/27/2012 12013 A Mar-12 Production PF&B extension cords Materials Damaged one pulled out and two without caps Steve 4/7/2012 3/27/2012 12010 A Mar-12 Sanitation CIP room outdated bottles Materials Incorrect bottles are refilled Randy 4/7/2012 3/27/2012 12020 G Mar-12 Warehouse DrP not put away at E.O.S Storage Not Stored Prod by no. end of 12-pk rack Steve 4/20/2012 3/27/2012 12040 FSL Mar-12 Admin Bioterrorism Training Missing add to new employee training Joe 4/29/2012 4/13/2012
  10. 10. Jules Fijux, MBA ASQ Certified Manager of Quality / OE jfijux@gmail.com

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