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