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Integrated Quality Assurance Management Awareness
October, 2008
Bob Grant Head, Office of Quality & Best Practices
Jed Heyes, EG&G QA Manager
Integrated Quality Assurance (IQA) Awareness - Management Agenda
Terms and Definitions
Management Structure Overview
Policy
Your Role
DOE Orders 414 and 226 overview
DOE Orders 414 and 226 relationship
Fermilab approach to QA implementation
What You Need To Know
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IQA Awareness - Terms & Definitions
Integrated Quality Assurance
Integrated Quality Assurance (IQA) – The foundation of integrated
QA management is line responsibility; i.e., the line organization
must have the authority, responsibility, and be held accountable
for integrating QA into, and as a part of, all of the work that they
do. Line responsibility for quality assurance is woven into the
organizational structure, as well as all aspects of the IQA program
at Fermilab.
The Laboratory Director has ultimate responsibility for all aspects
of QA for all work done under the FRA/DOE contract on the
Fermilab site. The Director delegates the QA responsibility to the
line managers (division/section/center heads) assigned to carry
out the work. The responsibility is further delegated to line
supervisors and ultimately to the workers.
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IQA Awareness - Terms & Definitions
Policy
A concise, documented description of an organization's approach to implement a
statute, program, or initiative. Policies provide strategic direction and guides
decision making.
Program
A program defines what must be done tactically to implement the policy
requirements. Programs once implemented become ongoing activities.
Management System
A group of interdependent processes and people that together perform a common
mission. (ASQ)
Process
A set of interrelated work activities characterized by a set of specific inputs and
value added tasks that make up a procedure for a set of specific outputs. (ASQ)
Procedure
The steps in a process and how these steps are to be performed for the process to
realize expected outcomes; usually documented. (Adapted from ASQ)
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IQA Awareness - Terms & Definitions
Project
A unique effort that supports a program mission having defined
points for starting and ending, undertaken to create a product,
facility, or system and containing interdependent activities planned
to meet a common objective or mission.
A project is a basic building block (in relation to a program) that is
individually planned, approved, and managed. . . (partial definition
from DOE 413.3A). Projects have a beginning, middle and end.
“As-Is” Mapping Process by which we actively gather data throughout
the Laboratory to obtain information about the current level of IQA
implementation.
Customer
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IQA Awareness - What is Quality?
- What is Quality?
“The totality of features and characteristics of a product or service
that bear on its ability to satisfy stated or implied means.”
ISO 8402
OR. . .
…the ability to achieve expected outcomes
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IQA Awareness - QA & QC Definitions
Quality Assurance (QA) - all the planned and systematic activities
implemented within a quality management system that can be
demonstrated to provide confidence (assurance) that a product or
service will fulfill expected outcomes.
Quality Control (QC) - the operational techniques and activities
used to fulfill requirements for quality. The process through which
we measure actual quality performance, compare it with standard,
and act on the difference.
Put this and next slide later to describe difference in emphasis?
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IQA Awareness - QA/QC Comparison
Quality Assurance - QA Quality Control - QC
An Assurance System - covers all Implementation – specific
activities from design, activities which directly
development, production, compare items against
installation, servicing and specified requirements and
documentation. provides feedback
Purpose: prevent problems from Purpose: compare to
occurring, detect them when they requirements, detect
do, identify the cause, remedy the difference, feedback
cause, and prevent reoccurrence.
Includes a number of assurance A subset of QA
activities: plans, procedures,
assessments, metrics, training,
improvement, QC etc
Strategic & Tactical – system focus Tactical – item, service focus
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IQA Awareness - Management Structure Overview
Laboratory
Director
Office of
Assurance Quality
Council and
Best Practices
Management
Systems for Safeguards Integrated
Financial Emergency Cyber
other DOE orders And ES&H Quality
Systems Management Security
or business Security Assurance
requirements
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IQA Awareness - Management Structure Overview
Laboratory
Director
Office of
Assurance Quality
Council and
Best Practices
Safeguards Integrated
Emergency Cyber
And ES&H Quality
Management Security
Security Assurance
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IQA Awareness – Policy Focus
Customer Focus…
understand and meet current and future requirements
Leadership…
establish unity of purpose, direction, and internal environment
Involvement of People…
all levels contribute
Process Approach…
understand and manage interactions
System Approach to Management…
managing a system of interrelated processes
Continual Improvement…
permanent objective
Factual Approach to Decision Making…
use of data
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IQA Awareness - Policy #10
Director’s Policy #10 – Quality Assurance
A facility-wide initiative designed to…
Ensure:
the intent to improve and sustain a facility’s ability to consistently,
dependably, and cost-effectively meet or exceed programmatic and
operational customer requirements.
the things we do meet the customer’s – DOE, universities,
collaborations, Fermi cross-functional/internal, and vendor -
expectations.
The primary tool for establishing expectations to…
develop implementing procedures; establish and maintain a
graded approach; perform audits and self-assessments; provide
tools for continuous/process improvement and adoption of best
practices; and provide guidelines for levels of inspection,
documentation, and recordkeeping.
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IQA Awareness – Contractor Assurance Policy, #39
Contractor Assurance - a facility-wide initiative designed to…
Ensure sufficient internal control and oversight systems are in
place and are operating properly.
Enable:
prompt identification and reporting of deficiencies and opportunities
for improvement
timely and effective implementation of corrective actions
sharing and use of learning
The primary tool for demonstrating operations are complaint, safe,
secure, efficient, and of the upmost quality when viewed from the
customer’s perspective.
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IQA Awareness - Ownership and Leadership
Management owns the direction and processes, especially for
compliance and change.
Managers are the leaders, and thus, they must take an active role in
the commitment, planning, and participation in order to improve
anything.
Participation – monitoring/measurement, review/analysis,
do/action, and assessment/control.
Leadership’s primary role is to help people do a better job.
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IQA Awareness – Highest Individual Responsibilities
Laboratory Director has the ultimate responsibility and authority for
everything at Fermilab.
Office of Quality and Best Practices has authority and responsibility for:
the day-to-day management of the Fermilab Integrated Contractor
Assurance Program
and the implementation, assessment, and improvement of the
Integrated Quality Assurance
Associate Laboratory Directors and the Heads of each Program and
Divisions/Sections/Centers are responsible for:
the performance and sponsoring of assessments to facilitate the
achievement of the organizational mission, objectives, and performance
requirements.
ensuring that their Division’s/Section’s/Center’s activities are conducted
in accordance with the principles and requirements of the IQA and
FICAP.
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IQA Awareness - Program Differences
FICAP:
Lab- wide assurance program covering multiple,
management systems.
Mandated by DOE O 226.1A in prime contract.
IQA:
Lab-wide management system focused on QA
requirements applied across all management systems.
Mandated by DOE O 414.1C in prime contract.
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IQA Awareness - Major 226.1A Requirements
Assurance Systems- encompass all aspects of the processes and
activities designed to:
Understand risk
Ensure objectives of the contractor’s Management Systems are being accomplished
Identify deficiencies and opportunities for improvement
Report deficiencies to responsible managers and authorities
Develop and effectively implement corrective and preventive actions
Share lessons learned across all aspects of operations
DOE Oversight Model
HQ Independent
Oversight
Site DOE
“The Field”
Fermilab
“The Contractor”
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IQA Awareness - Major 414.1C Objectives
To ensure that products and services meet or exceed customer’s expectations
To achieve QA for all work based upon the following principles.
That quality is assured and maintained through a single, integrated, effective QA
program (i.e., management system).
That management support for planning, organization, resources, direction, and
control is essential to QA.
That performance and quality improvement require thorough rigorous
assessment and corrective action.
That workers are responsible for achieving and maintaining quality.
That environmental, safety, and health risks and impacts associated with work
processes are minimized while maximizing reliability and performance of work
products.
To establish quality process requirements to be implemented under a QAP for the
control of suspect/counterfeit items (S/CIs) and control of safety software.
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IQA Awareness - Major 414.1C Requirements
The QAP must address the following management, performance, and
assessment criteria.
DOE O 414.1C 10 Criteria and S/CI Program
1. QA Program
2. Personnel Training and Qualification
3. Quality Improvement
4. Documents and Records
5. Work Processes
6. Design
7. Procurement
8. Inspection and Acceptance Testing
9. Management Assessment
10. Independent Assessment
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IQA Awareness – Assurance Council & 226/414 Relationship
Do we need?
Assurance
Council
Contractor Financial
Assurance Assurance
226.1A
Management Systems
414.1C
Cyber Safeguards ES&H Emergency Quality
Security & Management Assurance
Security
Program
Personnel Training and
Qualification
QA CA Quality Improvement
Documents and Records
Consolidated Assessment Consolidated Work Processes
Plan Assessment Plan
Self Assessment Independent Design
Management Assessment Assessment
S/CI Corrective and Preventative Management Procurement
QCI Action Review
CAR/NCR LLP Inspection and Acceptance
Root Cause Analysis Worker Feedback Testing
Document Control Strategic Planning
Quality (Process) Issues Management Assessments
Improvement Management
Independent Assessments
Suspect/Counterfeit Items
20 Management Criteria
IQA Awareness – 226/414 Relationship
226.1A Contractor
Assurance Contract Assurance
Management Systems 414.1C
Cyber Safeguards ES&H Emergency Quality
Security & Management Assurance
Security
Program
Personnel Training and
Qualification
QA CA Quality Improvement
Documents and Records
Work Processes
Consolidated Assessment Consolidated
Plan Assessment Plan Design
Management Criteria
Self Assessment
Management Assessment
Independent
Assessment
Procurement
People – Parts – Processes
S/CI
QCI
Corrective and Preventative
Action
Management
Review
LLP
Inspection and Acceptance
Testing
CAR/NCR
Management Assessments
Root Cause Analysis Worker Feedback
Document Control Strategic Planning Independent Assessments
Quality (Process) Issues
Management Systems
Improvement Management Suspect/Counterfeit Items
Management Criteria
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IQA Awareness - FICAP Requirements Mapping
FICAP DOE O 226.1A
Program Overview & Chapter 1 Att 1
Personnel Training and Qualifications Use IQA Att 1
Documents and Records Use IQA Att 1; App A; Sec 1
Assessment Use IQA Att 1; App A; Sec 2
Performance Chapter 5 Att 1; App A; Sec 7
Reporting Chapter 6 Att 1; App A; Sec 3
Lessons Learned Chapter 7 Att 1; App A; Sec 6
Worker Feedback Chapter 8 Att 1; App A; Sec 4
Issues Management Chapter 9 Att 1; App A; Sec 5
Dissenting Opinions Chapter 10 Att 1; App A; Sec 5D
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IQA Awareness - IQA Requirements Mapping
IQA DOE O 414.1C
QA Program Overview & ATT 2, pg 4-6, Sect. 3a1, a2
Chapter 1
Personnel Training and Qualification Chapter 2 ATT 2, pg 4, Sect. 3b1, b2
Quality Improvement Chapter 3 ATT 2, pg 4, Sect. 3c1-c4
Documents and Records Chapter 4 ATT 2, pg 5, Sect. 3d1-d2
Work Processes Chapter 5 ATT 2, pg 5, Sect. 3e1-e4
Design Chapter 6 ATT 2, pg 5, Sect. 3f1-f5
Procurement Chapter 7 ATT 2, pg 5, Sect. 3g1-g3
Inspection and Acceptance Testing Chapter 8 ATT 2, pg 6, Sect. 3h1, h2
Assessments Chapter 9 ATT 2, pg 6,
(Management, Independent) Sect. 3i, 3j1-j3
Suspect/Counterfeit Items Chapter 10 ATT 2, pg 6-8, a1-b9
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IQA Awareness - IQA/FICAP Crosswalk
IQA FICAP
QA Program Overview & Program Overview &
Chapter 1 Chapter 1
Personnel Training and Qualification Chapter 2 Personnel Training and Qualifications Chapter 2
Reference IQA
Quality Improvement Chapter 3 Performance Chapter 5
Reporting Chapter 6
Lessons Learned Chapter 7
Worker Feedback Chapter 8
Issues Management Chapter 9
Dissenting Opinions Chapter 10
Documents and Records Chapter 4 Documents and Records Chapter 3
Reference IQA
Work Processes Chapter 5
Design Chapter 6
Procurement Chapter 7
Inspection and Acceptance Testing Chapter 8
Assessments Chapter 9 Assessment Chapter 4
(Management, Independent) Reference IQA
Suspect/Counterfeit Items Chapter 10
BG’s input = delete
24
IQA Awareness - IQA & CA Parallel Implementation Approach
CA is implemented in parallel with QA implementation
Requirements are integrated
PEP & PMP are aligned and coordinated
Resources are common for some activities
Assessments will be integrated
Schedules are aligned and coordinated
25
IQA Awareness – CA/QA Schedules
Do we present schedules?
BG’s input = yes
26
IQA Awareness - What You Need To Know
Quality Policy – How does it apply to your job?
Who is responsible for quality? …..Everyone!
What are your department & site goals?
How do you support them?
What do you do to ensure your employees support them?
How does what you do impact management systems?
Be familiar with the DOE orders in your area or function,
Laboratory policies, written procedures that describe the job(s)
you do and where these are located.
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