ISMS QMS IntegrationISMS QMS Integration

Dr. Thomas Helms, ParsonsDr. Thomas Helms, Parsons

DOE SRS SWPF ProjectDOE SRS SWPF Project

BioBio

Tom is the Assurance Manager for the DOE Tom is the Assurance Manager for the DOE SRS Salt Waste Processing Facility Project, and SRS Salt Waste Processing Facility Project, and has also served as the ISMS & Assessment has also served as the ISMS & Assessment Manager, and Environmental Manager Manager, and Environmental Manager

Tom received his M.S. and Ph.D. at UT a couple Tom received his M.S. and Ph.D. at UT a couple of decades ago and has worked in the DOE of decades ago and has worked in the DOE environmental restoration/waste management environmental restoration/waste management arena sincearena since

IntroductionIntroduction IntegrationIntegration: To bring differing elements or parts : To bring differing elements or parts

together as one.together as one.

Management SystemManagement System: An organization’s : An organization’s documented set of policies, plans, procedures, documented set of policies, plans, procedures, programs devised and implemented to obtain programs devised and implemented to obtain mission objectivesmission objectives

Problem StatementProblem Statement: How and what does the : How and what does the contractor need to do, if anything, to affect contractor need to do, if anything, to affect direction to integrate ISMS and QMS?direction to integrate ISMS and QMS?

RequirementsRequirements

DOE O 414.1C: The Quality Assurance DOE O 414.1C: The Quality Assurance Program (QAP) “Integrates, where Program (QAP) “Integrates, where practicable and consistent … with other … practicable and consistent … with other … management system requirements … management system requirements … including ... DOE P 450.4, including ... DOE P 450.4, Safety Safety Management System Policy.”Management System Policy.”

Bring Together QMS & ISMS?Bring Together QMS & ISMS?

Obvious points of overlap: Corrective Obvious points of overlap: Corrective Action, Management Assessment, Action, Management Assessment, Training and Qualifications. . . HOWEVER:Training and Qualifications. . . HOWEVER:

QA/QC is concerned with Items and ServicesQA/QC is concerned with Items and Services

ISMS is about Protecting the Environment, the ISMS is about Protecting the Environment, the Worker and the PublicWorker and the Public

DD

SiteSite

FacilityFacility

ActivityActivity

SitePermits

Security

EmergencyManagementFacility

Permits

PDAS

FHA

ALARAAnalysis

JHASWP

NCSE

Waste Management

The ISMS – QMSRelationshipVaries withScope

Where they DivergeWhere they Diverge

QA and ISM diverge at the Activity Level QA and ISM diverge at the Activity Level

Activity-level ISMS finds little commonality Activity-level ISMS finds little commonality with QA elements such procurement with QA elements such procurement document control, item receipt inspection, document control, item receipt inspection, design control, etc.design control, etc.

The controls delineated in NQA-1 find scant The controls delineated in NQA-1 find scant utility in the development of a JHA or a pre-utility in the development of a JHA or a pre-job briefingjob briefing

Where they MergeWhere they Merge

QA/QC and ISM Converge at the Facility-QA/QC and ISM Converge at the Facility-Level ISMSLevel ISMS

Quality in the nuclear business has its Quality in the nuclear business has its origins in facility safety : 10 CFR 50, origins in facility safety : 10 CFR 50, Appendix BAppendix B

QA/QC Assures Flow Down of QA/QC Assures Flow Down of Design Requirements Design Requirements

Nuclear or High-Hazard Facilities: ISMS - Nuclear or High-Hazard Facilities: ISMS - QMS become one for safety-related SSCQMS become one for safety-related SSC DesignDesign AcquisitionAcquisition ReceiptReceipt InstallationInstallation Maintenance Maintenance OperationOperation

Safety Basis ProtectionSafety Basis Protection PDSA and DAS define performance & functional PDSA and DAS define performance & functional

requirements for credited SS/SC SSCrequirements for credited SS/SC SSC

The facility Design Basis translates performance & The facility Design Basis translates performance & functional requirements into specific design functional requirements into specific design requirements: Drawings, Data Sheets, Specifications, requirements: Drawings, Data Sheets, Specifications, Receipt Inspection Criteria Packages, Commercial Receipt Inspection Criteria Packages, Commercial Grade Dedication Packages, Inspection Test Plans, etc.Grade Dedication Packages, Inspection Test Plans, etc.

QA/QC’s primary function for Nuclear Facility QA/QC’s primary function for Nuclear Facility (particularly design build) is to assure (particularly design build) is to assure documented documented fidelity between the design requirements and the fidelity between the design requirements and the received and installed SSCs received and installed SSCs

Latent versus Active HazardsLatent versus Active Hazards

QA/QC is of modest utility when considering active QA/QC is of modest utility when considering active hazards, i.e., occupational safety and healthhazards, i.e., occupational safety and health

QA/QC was conceived to protect the environment, the QA/QC was conceived to protect the environment, the worker and the public when considering latent hazardsworker and the public when considering latent hazards

NQA-1 - Condition adverse to quality: “. . . A significant condition adverse to quality is one which, if uncorrected, could have a serious effect on safety or operability.”

Analyze Hazards/Define Controls

PDSAFHAShielding ModelsALARAEmission ModelsCode Review

Analyze Hazards/Define Controls

PDSAFHAShielding ModelsALARAEmission ModelsCode Review

Assure Acceptability -Work within Controls

Design ControlDocument ControlControl of ItemsControl of ServicesTest ControlProcurement Doc ControlControl Non Conforming ItemsQA Records

Assure Acceptability -Work within Controls

Design ControlDocument ControlControl of ItemsControl of ServicesTest ControlProcurement Doc ControlControl Non Conforming ItemsQA Records

Feedback for Improvement

Design ReviewAuditsManagement AssessmentCondition ReportsNCR Corrective Action

Feedback for Improvement

Design ReviewAuditsManagement AssessmentCondition ReportsNCR Corrective Action

Define Scope

Design Input ContractCodes of Record

SpecsDrawingsData Sheets

Define Scope

Design Input ContractCodes of Record

SpecsDrawingsData Sheets

ISMS Documented System

QAP

Design PhaseISMS QMS

ISMS at Facility Levelis QMS with Hazard Analysis

What Do We Integrate?What Do We Integrate?

A robust A robust QMSQMS will assure safety-related systems meet will assure safety-related systems meet design requirementsdesign requirements

Design ControlsDesign Controls assure SC/SS SSC functional and assure SC/SS SSC functional and performance requirements flow down to the design performance requirements flow down to the design requirementsrequirements

QMS fits under the ISMS: QMS fits under the ISMS: QA/QC is a functional area no different from Nuclear Safety, QA/QC is a functional area no different from Nuclear Safety,

Radiation Protection, Environmental Protection, Industrial Radiation Protection, Environmental Protection, Industrial Hygiene, etc. Each needs individual focus with integration to Hygiene, etc. Each needs individual focus with integration to produce a safe product (e.g., waste treatment facility, power produce a safe product (e.g., waste treatment facility, power plant, processing facility).plant, processing facility).

It’s The Management System . . . It’s The Management System . . .

NUREG-1055, 1987 Report to CongressNUREG-1055, 1987 Report to Congress Commercial nuclear Commercial nuclear quality failuresquality failures in the in the

1970s and ‘80s resulted 1970s and ‘80s resulted not from poor QMSnot from poor QMS

FailuresFailures resulted from broader resulted from broader Management Management System weaknessSystem weakness touching all aspects of the touching all aspects of the organizationorganization

We need to focus on We need to focus on THE MANAGEMENT THE MANAGEMENT SYSTEM SYSTEM from a holistic perspectivefrom a holistic perspective

Human and Process ElementsHuman and Process Elements

Organizational performance is a function Organizational performance is a function of of processesprocesses and the and the qualities of thequalities of the personnelpersonnel

I contend that no organization can I contend that no organization can conduct complex missions successfully conduct complex missions successfully w/o a Management System containing w/o a Management System containing the basic elements of ISMS the basic elements of ISMS

Human ElementHuman ElementGuiding Principles (GP)… ApproximatelyGuiding Principles (GP)… Approximately

1.1. Organizational priorities: Safety/Quality, Organizational priorities: Safety/Quality, Schedule, & Cost Schedule, & Cost (GP4)(GP4)

2.2. Authorities and Accountabilities Authorities and Accountabilities (GP1)(GP1)

3.3. Responsibilities and Functions Responsibilities and Functions (GP2(GP2, CR1), CR1)

4.4. Competencies & Qualifications Competencies & Qualifications (GP3(GP3, CR2), CR2)

5.5. Communication: Includes SCWE, HPI Communication: Includes SCWE, HPI ((The too The too often neglected “I” in ISMSoften neglected “I” in ISMS))

DOE O 414.1CDOE O 414.1C: : CR = Criteria 1 – 10, CR = Criteria 1 – 10,

Process ElementsProcess ElementsCore Functions (CF) + 2 Guiding Principles ApproximatelyCore Functions (CF) + 2 Guiding Principles Approximately

1.1. Define scope and requirements: Define scope and requirements: CF1, GP5CF1, GP5

2.2. Analyze the risks (hazard if probability = 1): Analyze the risks (hazard if probability = 1): CF2CF2

3.3. Tailor risk control strategies based on consequences or Tailor risk control strategies based on consequences or probabilities: probabilities: CF3, GP6, CF3, GP6, CR4, Graded ApproachCR4, Graded Approach

4.4. Verify that risk controls are in place: Verify that risk controls are in place: CF4, GP6CF4, GP6

5.5. Authorize the activity within defined risk controls: Authorize the activity within defined risk controls: GP6GP6

6.6. Conduct activities based on controls and scope: Conduct activities based on controls and scope: CF4, CF4, CR5, 6, 7CR5, 6, 7

7.7. Evaluate and measure performance: Evaluate and measure performance: CF5CF5, CR3, 8, 9, & 10, CR3, 8, 9, & 10

8.8. Improve based on performance analysis: Improve based on performance analysis: CF5,CF5, CR3, 8, 9, & 10 CR3, 8, 9, & 10

It’s Not Just About SafetyIt’s Not Just About Safety

If an organization with a complex or If an organization with a complex or hazardous mission is not following the hazardous mission is not following the management system elements for management system elements for major aspects of their endeavor – major aspects of their endeavor – not not just safetyjust safety – it’s heading for – it’s heading for performance problems if not failureperformance problems if not failure

ConclusionsConclusions

If the correct policies, plans and procedures are If the correct policies, plans and procedures are in place to support ISMS & QMS, then in place to support ISMS & QMS, then integration should be integration should be implicit and passiveimplicit and passive versus explicit and active.versus explicit and active.

Integration needs to be Integration needs to be explicit and activeexplicit and active between organizations and disciplines between organizations and disciplines responsible for the identification, design, responsible for the identification, design, acquisition, acceptance and installation of acquisition, acceptance and installation of safety-related SSCsafety-related SSC