Integrating ISO 9001 and Integrating ISO 9001 and ISO 14001 ISO 14001 Novo Nordisk BioChem North America Jennifer Pierce, QA Specialist
Integrating ISO 9001 and ISO 14001Integrating ISO 9001 and ISO 14001
Novo Nordisk BioChem North AmericaJennifer Pierce, QA Specialist
Overview of Novo NordiskOverview of Novo Nordisk Largest producer of industrial enzymes in the
world. Healthcare business produces diabetes care
products (insulin) Headquartered in Denmark. Production facilities in Denmark, US, Brazil, China,
Switzerland. Sales offices throughout the world
For more info:
Visit our web site at http://www.novo.dk
Franklinton, NC FacilityFranklinton, NC Facility
Fermentation, Recovery, Granulation Sales, Marketing, Regulatory Affairs QC, Tech Service, Development/Research Purchasing, Warehouse/Distribution Waste Management, Engineering
We employee approximately 350 employees on 3 shifts.
NNBNA- Franklinton, NCNNBNA- Franklinton, NC
Products produced with enzymesProducts produced with enzymes
Spreading Spent BiomassSpreading Spent Biomass
Waste Water IrrigationWaste Water Irrigation
Laboratory WasteLaboratory Waste
Raw Material UnloadingRaw Material Unloading
ISO BackgroundISO Background
ISO 9002 certified in 1996Re-certified to ISO 9001 in 1999Recommended for ISO 14001
certification in Mar 2000
Structure of Quality SystemStructure of Quality System
Global Top Level
Requirements
Site Wide General and/or
Cross-functional SOP’s
DepartmentalSpecific Requirements and SOP’s
““Grass Roots” Implementation of ISO 14001Grass Roots” Implementation of ISO 14001
Project called EQS “Environmental Quality System”
Decentralized implementation Initial Management Roll-out Steering Committee & Working Committee Each employee trained in EQS program Each employee participated in Aspect &
Impact Analysis
EQS Organizational StructureEQS Organizational Structure
STEERING COMMITTEE: Responsible for direction and guidance implementation of ISO 14001.
WORKING COMMITTEE: Responsible for inter-departmental communication and implementation issues. Representatives from each functional area.
#1 Key Rule to Integrating#1 Key Rule to Integrating
USE EXISTING DOCUMENTS WHENEVER POSSIBLE!!!!
Where did we use existing docs?Where did we use existing docs? Corrective & Preventative Actions Document Control Records Internal Audits Training Programs Operational control procedures in production and
distribution Change Control in production Legal & Regulatory Requirements Spill and Hazard Response (existing Safety SOP’s) Equipment Maintenance
Corrective & Preventative ActionsCorrective & Preventative ActionsAn Action Request must be initiated in the following cases: A reoccurring problem that has negative effect on the quality of NNBNA products,
services, development and optimization work. A problem resulting in non-conforming product(s), including dispensations. A reoccurring GMP issue that has negative effect on the safety of NNBNA products. A reoccurring problem with an NNBNA product, process, or work related activity
that adversely affects the environment An action request may also be initiated in the following cases: As a preventative action to address a potential problem Critical equipment problems Process data analysis showing key process parameters to be outside the quality
range specified in the Basis Directions Unplanned process or development/optimization project deviations Any departmental or facility problems that could result in a negative affect on
NNBNA products, services, development and optimization work or the environment. Any departmental or facility incident of non-compliance with environmental or
safety regulations, or permit requirements.
Area Scope Month Sched Date
Audit Type
EQS Training Audit Evaluation of EQS Awareness training Jan 1/13/00 E
Site EQS audit Evaluation of readiness for ISO 14001 certification Jan1/17/00-1/19/00
E
EQS Records Audit Evaluation of Environmental records Mar 3/3/00Recall Procedure Mock recall of 2 batches Apr Q
Emergency Action PlanActions to take in the event of an emergency (Include the following departments: Eng, Security, WH, Ferm,
WM)May S,E
QA Evaluation of NNBNA Site-Wide Quality System May 5/30/00 Q
Contractors & Suppliers
Evaluation of training given to contractors and suppliers regarding EQS. Training/documentation to
contractors Permit system, fire watch, records (Include following dept: Maintenance, Engineering,
Recovery, Waste Mgmt)
May E/S
Development Projects Evaluation of projects in EDA Jun Q
Change ControlEvaluation of changes made to equipment,
materials and databases.Also include In-production experiments
Jun Q/E
Operational Control Monitoring & Measuring
Evaluation of controlling significant aspects/impacts. (Include the following departments: Ferm, Rec,
GranT, Maint, WM)Jul E
Training Site evaluation of Quality training Aug QWarehouse Complete department audit Sep Q
IT Complete department audit Sep Q
Hazard Communication Enzyme Safety
MSDS, Labeling, Training Dust monitoring, Safe Practices, Training (Include following dept:
Recovery, Granulation, QC, Waste Management)Oct S
Confined Space Entry & Forklift Safety
Permit system, Monitoring, Training Forklift inspection, Cages, Training (Include the following
dept: Ferm, Maint, GranT, WH)Oct S
Internal Audit PlanInternal Audit Plan
EQS Awareness Training QuizEQS Awareness Training Quiz What is EQS and what is it’s purpose? Where is the environmental policy located at? What is an impact to the environment? Do you have any control over how your job affects the environment? How does your job affect the environment? If you see that an operation can or should be improved, can you do
anything about it and if so what? How do you clean up spills? What would you do if you had an oil spill? What are some significant impacts in this department? Which of the top ten Targets and Objectives affect our department? Where is the “Emergency Action Plan” located? Who is responsible for EQS here at NNBNA?
AMMONIAOR OTHER
INSIDE OROUTSIDE
BLDG.
OTHER CHEMICAL
DO SAFELYSOURCE IF POSSIBLE TO
IF ONGOING - STOP
(4290) TO NOTIFY ALL TOSTAY OUT OF AREA
USE PLANT-WIDE PAGING
OUTSIDE INSIDE
LARGEUNCONTROLLED
OR SMALLCONT ROL L E D
LA R GE UNCONTROLLE D
DO SAFELYIF ONGOING - STOP
SOURCE IF POSSIBLE TO
IN BUILDINGSTAY OUT OF AREANOTIFY EVERYONE
BARRIER TAPEWITHISOLATE AREA
SHIFTNOTIFYSUPERVISOR
IN BLDG.IF DANGER EXISTS
ACTIVATE FIRE ALARM
CALL FIRE DEPARTMENTIF NEEDED
AND NOTIFY SECURITY
IS CLEARWAIT UNTIL AREA
TO ENTER
MANAGEMENT WITHSPILL INFORMATION
REPORTS AND OTHERCOMPLETE INCIDENT
NOTIFY SUPERVISOR
CALL WASTE
APPLICABLE REPORTS
ISOLATE
WEARING PPE (SEE MSDS)(GOGGLE S , GLOVES , APRON)
FLUSH SPILL TO NEAREST
AREATHE SPILL
SUPERVISORSHIFTNOTIFY
SMALL CONTROLLED
PROCESS DRAIN
TO STAYNOTIFY PERSONNEL
CLEAR OF AREA
CONCE NTR ATEORDUST
SUPERVISORSHIFTNOTIFY
(RE SPIRATOR & GOGGLES)CLEAN W/LOW PRESSURE
FLUSH OR WET VACUUM
WEARING PPE
NO HIGH PRESSUREOR BROOMS
OF WATERCLEAN THOROUGHLYWITH LARGE AMOUNT
MATERIAL GOING TOMANAGEMENT OF
NOTIFY WASTE
PREPARE INCIDENTREPORTS AND OTHERAPPLICABLE REPORTS
SUPERVISORCLOSE DOORS LEADINGNOTIFY CONTROL ROOM
TO ROOM
VENTILATIONOPEN FORCED
CHANGE UNIFORMSPERSONNEL EXPOSED TO
DUST SHALL SHOWER &
EVALUATE S IZEFULL FACE
RESPIRATOR,
OPEN DOORSTO STAY AWAY
NOTIFY OTHERS ACTIVATE SITE-WIDEALARMFIRE ALARM
EVACUATE BLDG.ACTIVATE
SUPERVISORNOTIFYSHIFT
AMMONIA
ENZYME, BROTH, DUST, OR CONCENTRATE
& LOCATIONOF RELEASE
SMALL
LARGE
CATASTROPHIC(SITE AFFECTED)
IN GranTDUST RELEASE
SUPERVISOR
?
?
?
?
?
CONCENTRATE
AREAGO TO GATHERINGPERFORM HEAD COUNT
GO TO SITE-WIDEPERFORM HEAD COUNT
GATHERING AREA
SPILL RESPONSE AND NOTIFICATION
SPILL
(Blue)STORM SEWER?
IS SPILL
NO
R E A CHING S OILOR GOING DOWN YES
(Red)PROCESS SEWERFLUSH TO
MANAGEMENTWAS TE
(SEE PROCEDURE)
CALL
YES NO
SUPERVISORSHIFTNOTIFY
NOTIFY SUPERVISOR
SHIFTSUPERVISOR
NOTIFY
REPORTS AND OTHERCOMPLETE INCIDENTAPPLICABLE REPORTS
EMERGENCY - STOPAMMONIAACTIVATE
EMERGENCY - STOPACTIVATEAMMONIA
ENZYME
CHEMICAL
W EARING
ISOLATE AREA
BROTH OR
BROTH
SUPERVISORAPPROVAL
AFTERPROCESSSEWER
ORSTORM
?
STORM SEWER
STORMSEWER
SEWERPROCESS
TO PROCESS SEWER
TO PROCESS SEWER
?
(RED)
(Blue)
CALL 911OR SECURITY
SHIFT SUPERVISOR
Where did we write new docs?Where did we write new docs? Approximately 100 existing site-wide SOP’s No more than 10 revised for EQS. 12 new site-wide SOP’s written for EQS.
Hundreds of existing department SOP’s. No more than 10 per dept revised. Under 15 new department SOP’s
– Examples: Hazardous Waste in Labs, Operation of Wet Scrubber
Approximately 25 Waste Management dept SOP’s written (were not part of ISO9001)
New Site Wide DocsNew Site Wide Docs NNBNA Environmental Policy EQS Guiding Document Steering Committee Charter Working Committee Charter Environmental Aspect & Impact Identification EQS Aspect Ranking & Significance Determination Establishing Site Objectives and Targets Identification of Legal & Other Requirements EQS Management Reviews EQS External Communications Applicability of the ICC Charter to the NNBNA EQS Environmental Compliance Auditing Oil Spill Control & Countermeasures
EQS Commandments- PolicyEQS Commandments- Policy
Do it right! - Follow procedures to comply with regulations and NNBNA requirements.
Keep it clean! - Prevent pollution by following instructions, preventing releases, and containing any that do occur.
Make it better! - Do your part by suggesting ideas for improvement through the use of Preventive Action Requests.
Stumbling BlocksStumbling Blocks
The procedure that was the most time consuming to write and caused the most headaches was:
Aspect & Impact AnalysisThis process was re-done 3 times. It
became easier to write the procedure after we had completed the process.
Aspect and Impact AnalysisAspect and Impact Analysis
The Steering Committee assisted each dept/area.
All activities at were evaluated.A total of 864 aspects were identified
and entered into a database.
RatingRating
Each activity and its associated aspect/impact was given an initial rating:
• 1: Aspect needs attention or there is a high opportunity for improvement
• 2: Possible opportunity for improvements • 3: Current controls are sufficient. Little or no
opportunity for improvements A total of 83 #1 ratings were identified.
RankingRanking
Aspects with #1 ratings were then ranked.
• Ranking helps prioritize and determine significance
A total of 30 rankings were done, with some aspects combined, while others ranked separately.
Determine SignificanceDetermine Significance Anything above a score of 16 was
considered significant. Also did a “sanity check” to see if it made
sense. 1 additional aspect was considered
significant even though its ranking was lower than 16.
A total of 11 aspects were considered significant.
Objectives & TargetsObjectives & Targets
From the significance rating, a business practicability score was subtracted to give a final score.
Using the aspect with the lowest score from the ranking as the cutoff, anything with a higher score was used when considering objectives and targets.
A total of 14 aspects were used to set objectives and targets.
Summary of A&I AnalysisSummary of A&I Analysis
864 aspects 83 #1 ratings30 rankings11 significant aspects14 aspects used for setting
objectives and targets.
Management ReviewManagement Review Decided to keep separate from quality
management review initially to ensure proper focus by management.
Used same structure instead of re-creating.
Some elements are evaluated during both reviews (C/P actions, audits)
In the future will evaluate whether or not to combine.
ConclusionConclusion
Use existing documents as much as possible
Keep it simpleInvolve as many employees as
possible