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2. My Perspective. 28 years Applicable ExperienceMostly QA/QC in project environmentAssociated with PAAA since 90Trained to original Rule intentQA Order / Rule SME 91- 95Quality / PAAA Consulting to DOE subs 95 - 98Quality Mgr, PAAA Coordinator 98 - 01Quality Mgr. SNS Project Sub 01 - 03PAA
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1. PAAA 101:The Past, Present, & Future
2. 2 My Perspective 28+ years Applicable Experience
Mostly QA/QC in project environment
Associated with PAAA since 90
Trained to original Rule intent
QA Order / Rule SME 91- 95
Quality / PAAA Consulting to DOE subs 95 - 98
Quality Mgr, PAAA Coordinator 98 - 01
Quality Mgr. SNS Project Sub 01 - 03
PAAA Coordinator 03 - 05
Quality Consulting 05 - present
3. 3 Price-Anderson Amendments Act The Past
Background
The Present
Key Terms
Applicability
Rules
Implementation
Lessons
The Future
New Rules
New Scope
What Now?
4. 4 Price-Anderson Amendments Act Background
Price-Anderson Act (1957)
Congress, concerned about the publics ability to seek relief in case of a nuclear incident, enacted legislation to allow it to do so.
Legislation originated from Atomic Energy Act of 1954.
Provided indemnification of DOE contractors performing nuclear activities for the government
5. 5 Price-Anderson Amendments Act The Past
Background
The Present
Key Terms
Applicability
Rules
Implementation
Lessons
The Future
New Rules
New Scope
6. 6 Key Terms Price-Anderson Amendment Act (PAAA) - enacted in 1988, it re-authorized Price Anderson to include all nuclear activities of DOE and its contractors. Also reauthorized under the Energy Policy Act [2005].
Indemnification - DOE insures its nuclear contractors in case of accidents in exchange for a program that ensures compliance with PAAA rules Instructor Notes: Review key definitions.
Instructor Notes: Review key definitions.
7. 7 Key Terms (Cont.) DOE Noncompliance Tracking System (NTS) a web-based database system, established and managed by DOE, that is the repository for NTS Reports and their associated corrective actions
Internal Reportable Potential PAAA Noncompliance noncompliance that does not exceed the threshold for reporting in NTS and requires internal tracking
NTS Reportable Potential PAAA Noncompliance exceeds the reporting threshold established in DOE guidance Instructor Notes: Review key definitions.
Instructor Notes: Review key definitions.
8. 8 Key Terms (Cont.) Enforcement Process typically includes inquiry/investigations, enforcement conferences, and enforcement actions which can include civil penalties (fines)
Notice of Violation - DOE process of enforcement which can include civil penalties Instructor Notes: Review key definitions.
Instructor Notes: Review key definitions.
9. 9 Current PAAA Rules Implementing Rules:
10 CFR Part 820
(Procedural Rules for DOE Nuclear Activities)
10 CFR Part 830
(Nuclear Safety Management)
Subpart A Quality Assurance.
Subpart B Safety Basis
10 CFR Part 835
(Occupational Radiation Protection)
10 CFR Part 708
(DOE Contractor Employee Protection Program DOE rules promulgated 1995/2001 (QA), 1996/1998 (Rad), 2000 (Whistleblower), and 2001 (Safety Basis).DOE rules promulgated 1995/2001 (QA), 1996/1998 (Rad), 2000 (Whistleblower), and 2001 (Safety Basis).
10. 10 Price-Anderson Amendments Act Applicability
Persons conducting activities that affect or may affect the safety of DOE nuclear facilities or activities
Contractor and subcontractor employees
Vendors
Others, including visitors
and DOE personnel
11. 11 Price-Anderson Amendments Act Applicability (continued)
Nuclear facilities and activities (includes radiological)
Work in support of those facilities or activities - *includes design, design review, procurement, receipt inspection, dedication
Activities that can cause or contribute to nuclear/ radiological incidents
Have the potential to cause radiological harm
12. 12 Price-Anderson Amendments Act Nuclear Facility
Reactor and nonreactor nuclear facilities.
Nonreactor nuclear facilities are those that conduct activities or operations involving radioactive and/or fissionable materials in such form and quantity that a nuclear hazard potentially exists to the employees or the general public. Instructor Notes: Review information on the slide.
Discuss potential to do radiological harm
Instructor Notes: Review information on the slide.
Discuss potential to do radiological harm
13. 13 The QA Rule In the Beginning
DOE Order 5700.6c
Proposed Rule
DOE Evangelism and Contractor Skepticism
Indoctrination & Training to Requirements
Rule promulgated
Implementation Period
14. 14 10 CFR Part 830 Nuclear Safety Management Purpose:
Governs the conduct of the DOE management and operating contractors and other persons at DOE nuclear facilities.
Scope:
Part 830 includes Subpart A, Quality Assurance Requirements, and Subpart B, Safety Basis Requirements.
15. 15 10 CFR Part 830, Subpart A Quality Assurance Requirements Establishes quality assurance requirements for contractors & subcontractors conducting activities, including providing items or services, that affect, or may affect, nuclear safety of DOE nuclear facilities.
16. 16 10 CFR Part 830, Subpart B Safety Basis Requirements Establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities.
Define scope of work and associated hazards
Prepare a documented safety analysis (DSA) that evaluates release of hazards and establish hazard controls
Operate in accordance with DSA hazard controls
17. 17 10 CFR Part 830, Subpart B Safety Basis Requirements Covers performance of work, safety basis, unreviewed safety question process, DSA, technical safety requirements, preliminary DSA, and DOE approval of safety basis.
Keep DSA current with facility configuration and operations
18. 18 10 CFR 835 -Occupational Radiation Protection Identifies the elements of a comprehensive radiation protection program, regulatory requirements, and defines the ALARA process as the primary means of maintaining occupational radiation doses below regulatory limits.
19. 19 10 CFR Part 708 -DOE Contractor Employee Protection Program Provides procedures for processing complaints by employees of DOE contractors alleging retaliation by their employers for disclosure of information concerning danger to public or worker health or safety, substantial violations of law, or gross mismanagement; for participation in Congressional proceedings; or for refusal to participate in dangerous activities.
20. 20 Implementation Lessons There is No Single Solution
Cost is of Great Concern
Small companies have very real problems
Management Attitude and Actions are Keys to success or something less.
21. 21 Common Concerns Extent of Regulatory Oversight
Cost of compliance
Initial
Ongoing
Contingency
Cost of non-compliance
Investigation
Fines
Other
22. 22 Divergent Approaches Any where within the spectrum of possibilities
Big to Small
Extensive to Minimal
Risk Based
Evolve with experience
Approach Changed as Rule changes Which companies can afford the ongoing infrastructure cost?Which companies can afford the ongoing infrastructure cost?
23. 23 Organizational Impacts Management
Attitude
External Face
Internal Face
Actions / Responses
External
Internal Strict compliance?
Full theoretical buy-in?
Something less?
Window Dressing?Strict compliance?
Full theoretical buy-in?
Something less?
Window Dressing?
24. 24 Recent Events Energy Policy Act [Title VI - PAAA 2005]
Extends PAAA indemnification & enforcement to 2025
Indemnification amount increased to 10 billion
Exemption from civil penalties removed for not-for-profits
Removal of exemption takes effect as new contracts are awarded
Civil penalties cant exceed the amount of fees earned in any year
First 10 CFR 708 Case
Involving retaliation against an individual for raising nuclear safety concerns see EA 2005-03
This was against a local subcontractor to DOE
25. 25 Price-Anderson Amendments Act The Past
Background
The Present
Key Terms
Applicability
Rules
Implementation
Lessons
Recent Events
The Future
New Rules
New Scope
26. 26 Scope Expansion New Rules with New Scope
10 CFR 850, Chronic Beryllium Disease Prevention
10 CFR 851, Worker Safety and Health
[OSH Rule]
27. 27 10 CFR 850/851 Status Rule Issued February 09, 2006
One year implementation period
28. 28 What Now? Trend Analysis
Predictions
Questions?
29. 29 Thank You! James Yoder
J. Yoder Consulting Services
jkyoder@gmail.com
865.607.5927 [c]