Upload
jules-fijux-mba
View
204
Download
3
Embed Size (px)
Citation preview
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
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
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
Item Description
% C
om
ple
te
Ow
ner
Sta
tus
Sta
rt
Co
mp
lete
Tar
get
4/21
/201
5
4/28
/201
5
5/5/
2015
5/12
/201
5
5/19
/201
5
5/26
/201
5
6/2/
2015
6/9/
2015
6/16
/201
5
6/23
/201
5
6/30
/201
5
7/7/
2015
7/14
/201
5
7/21
/201
5
7/28
/201
5
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
Certification Date Phase 1 Responsibility Date Due Status
Develop Plan
Senior Leadership Tra ining
Resource Al location
Requirements Tra ining
Team Names Signatures Gap Assessments
Sponsor: Process Flow
Lead: Stage 1 Processes
Member: Veri fication Planning
Member: Summary 0%
Member:
Member: Phase 2 Responsibility Date Due Status
RTM: Risk Assessment Tra ining
MSM: Perform Risk Assessments
Bus iness 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 Tra ining
Management System Processes
Bus iness System Processes
Maintenance System Processes
Management System Veri fication
Summary 0%
Phase 4 Responsibility Date Due Status
Analys is of Veri fication Results
Actions From Analys is
#DIV/0! Summary -$ How to use a Management System Tra ining
Preassessment
Corrections from Preassessment
Certi fication
Attendees Summary 0%
Roadblocks Next Steps Next Visit
CommentsProject Status #DIV/0!
Date Last
Reviewed
Facility Name
Current Plant Status
Plan Goal
Operational Controls & PAS Required Corrections
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
ID Clause RequirementProcesses used to control
Requirement
Verification
ActivityFrequency
Evidence
Record
FST Verification
Method
1
4 Construction and layout
of buildings
4.1 General requirements
Bui ldings are des igned, constructed
and maintained in a manner
appropriate to the nature of the
process ing operations that are
carried out, the food safety hazards
associated with those operations ,
and the potentia l sources of
contamination from the plant
environs . Bui ldings are of durable
construction which presents no
During normal management
routines i tems are identi fied
and corrected
GMP
Inspection
Monthly GMP Record Food Safety
Coordinator
Review
2
4.2 Environment Cons ideration is given to potentia l
sources of contamination from the
loca l environment.
During the annual ri sk
assessment process , FST wi l l
perform a PRP Risk Assessment
to identi fy changes
PRP Risk
Assessment
Annual ly Assessment FST Approval
3
4.2 Environment Food production is not carried out in
areas where potentia l ly harmful
substances could enter the product
During the annual ri sk
assessment process , FST wi l l
perform a PRP Risk Assessment
to identi fy changes
PRP Risk
Assessment
Annual ly Assessment FST Approval
4
4.2 Environment The effectiveness of measures taken
to protect against potentia l
contaminants are periodica l ly
reviewed.
During the PRP Risk Assessment
Process , the controls are rated
and rerated as needed
PRP Risk
Assessment
Annual ly Assessment FST Approval
5
4.3 Locations of
establishments
The s i te boundaries are clearly
identi fied.
Curb, RR Tracks , Outer Wal ls , Map GMP
Inspection
Monthly GMP Record Food Safety
Coordinator
Review
6
4.3 Locations of
establishments
Access to the s i te i s control led. Locked doors , gates , e-cards ,
receptionis t
GMP
Inspection
Monthly GMP Record Food Safety
Coordinator
Review
7
4.3 Locations of
establishments
The s i te i s maintained in good order.
Vegetation is tended or removed.
Roads , yards and parking areas are
dra ined to prevent standing water and
are maintained.
Vegetation is maintained by
intera l persons
Standing water i ssues are
identi fied during normal
management routines and action
i tems are discussed and
corrected
GMP
Inspection
Monthly GMP Record Food Safety
Coordinator
Review
#ID'd
From
Date
OpenArea 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 Steve12/31/201
25/9/2012
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