THREE Known KEY Assessments

1
THREE Known KEY Assessments

• ISM Program Independent Assessment
• Scoping Visit September
• On site October
• Results will be used as a base line for
  improvements
• Possible OA - 40 ISM Program Assessment FY06
• Similar to 2000 verification Assessment
• Large DOE team on site for a long period
• The BNL QA Program supports all aspects of ISM
• PERT Review

2
Acquisition Management SystemPERT Review

• The Acquisition Management System will be
  reviewed for recertification in
• May 2006 by the DOE-sponsored Procurement
  Evaluation Re-engineering
• Team (PERT). The team consists of DOE and
  contractor personnel from other
• DOE facilities. Our system certification permits
  us to award contracts up to
• 5M without prior DOE approval (with some small
  exceptions). If we lose
• our certification, every order we want to issue
  would require prior DOE approval.
• Therefore, this review is critical to all
  employees.
• The review will cover all aspects of procurement.
  The criteria include the
• following that may be of interest to QA reps
• Personnel training, experience and knowledge to
  effectively and efficiently comply with company
  policy, applicable laws, regulations and DOE
  prime contract requirements (this includes those
  related to quality)
• Solicitations and subcontracts incorporate the
  required prime contract flow-down clauses to
  adequately protect the Governments interest
  (including quality)

3
Acquisition Management SystemPERT Review

• contd
• The review will cover all aspects of procurement.
  The criteria
• include the following that may be of interest to
  QA reps
• BSA has a system for grading the performance of
  subcontractors on completed subcontracts
• BSA uses this grading system in determining
  whether prospective contractors are responsible
• BSA has a system in place to use capable and
  reliable contractors who either have track
  records of successful past performance or can
  demonstrate a current superior ability to perform
• Technical evaluations are adequate and support
  source selection decisions

4
Acquisition Management SystemPERT Review

• There are also the following best practice
  criteria
• BSA has a supplier quality and recognition
  program
• BSA has a system for problem identification,
  data collection and analysis, and a plan for
  improvement

5
Quality Management Office

• Procurement
• Quality Assurance
• (QA-QP-002)
• September 2005
• Joe Labas
• QMO/PPM

6
Objective

• To understand BNLs responsibility in meeting DOE
  Procurement Quality requirements, including the
  requirements for purchased items and services
  that affect or may affect, radiological work.
• How do we (BNL) fulfill our responsibility?
• Translation What is the Quality Reps. (QR) role
  in
• procurement?

7
Procurement QA

• 7 Questions?
• Do we need to evaluate the supplier beforehand?
  i.e. Is the supplier capable of providing
  items/services to the requirements (technical,
  quality, cost and schedule)?
• Are quality requirements necessary and are they
  clear, concise and communicated (flowed down)
  effectively?
• Is the ESHQ Risk Level (QA Cat.) commensurate
  with the item/service being procured AND its use/
  application?
• What is the best approach to ensure requirements
  are met, e.g. what type of verification is
  necessary?
• Is this procurement related to any radiological
  work?
• How do we report and track supplier problems?
• How do we monitor/rate suppliers performance?

8
Agenda

• Drivers
• Internal Requirements SBMS Subject Areas
• Web Requisition
• BNL Supplier Quality Information System
• Value Added?

9
Drivers External Requirements

• DOE O 414.1 (Order) and 10 CFR830.120 (Rule)
• Quality Assurance
• Both Consist of 10 Criteria

• 1-Program (using a graded approach)
• 2-Personnel Training Qualification
• 3-Quality Improvement
• 4-Documents Records
• 5-Work Processes

• 6-Design
• 7-Procurement
• 8-Inspection and Acceptance Testing
• 9-Management Assessment
• 10-Independent Assessment

• The BNL Quality Assurance Program addresses the
• DOE Order and Rule criteria.

10
Drivers External Requirements

• DOE Quality Order and Rule
• Criterion 1 QAP
• Implement QA criteriausing a graded approach
• Criterion 3 Quality Improvement
• Nonconformance, C/A P/A
• Criterion 7 Procurement
• Procure items services that meet ESTABLISHED
  requirements
• Evaluate prospective suppliers
• Ensure approved suppliers continue to provide
  acceptable items and services
• Criterion 8 - Inspection Acceptance Testing
• Using established acceptance performance
  criteria

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Drivers External Requirements

• The difference between the QA Order and the
• QA Rule
• The Order is issued by the DOE to its
  contractors.
• The Rule is a federal law, and is enforceable via
  the Price Anderson Amendment Act (PAAA).

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Procurement-related QA Subject Areas

• Graded Approach for Quality Requirements
• Work Planning and Control for Experiments and
  Operations
• Screening Guidelines for Work Planning Control
  and Application of the Quality Graded Approach
• Supplier Evaluation (Evaluating Seller QA
  Program)
• Purchase Requisition Review for Quality-related
  Requirements
• QR (or QMO, PPM) can assist with defining quality
  requirements
• Inspections and Acceptance
• Calibration of Inspection, Measure, and Test
  Equipment
• Nonconformance, Identifying and Reporting
• Corrective and Preventive Action -
• SCAR

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Graded Approach for Quality
As defined in 10CFR 830.3, Nuclear Safety
Management Definitions

• Graded approach means the process of ensuring
  that the level of analysis, documentation, and
  actions used to comply with a requirement in this
  part are commensurate with
• (1) The relative importance to safety,
  safeguards, and security
• (2) The magnitude of any hazard involved
• (3) The life cycle stage of a facility
• (4) The programmatic mission of a facility
• (5) The particular characteristics of a facility
• (6) The relative importance of radiological and
  nonradiological hazards and
• (7) Any other relevant factor.

14
Graded Approach for Quality Reqs S/A

• Intent is to apply more rigor in QA activities as
  the risk/vulnerability/liability of an
  activity/project increases.
• The Risk Table (Graded Approach)
• Located in Work Planning Control SA
• 4 ESHQ Risk Levels
• A1 (Critical)
• A2 (Major)
• A3 (Minor)
• A4 (Negligible)

Risk-significant
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Graded Approach for Quality Reqs SA
Screening Guidelines for Work Planning Control
and Application of the Quality Graded Approach

• Proposal to reduce to 2 levels for procurements
• Risk-significant (A1/A2)
• Risk Insignificant (A3/A4)
• with Guidance linked directly to web req.

16
Supplier Evaluation (QA Program) S/A

• Review of a suppliers capability (e.g. QAP) is
  required if the risk is either A1Critical or
  A2Major, unless
• There is justification to forego an evaluation,
  such as sole source (which can be considered the
  evaluation), OR off-the-shelf/catalog purchases
• Supplier has a documented, acceptable evaluation
  BNL within the last 3 years (need to SHARE
  evaluation information!)
• Note Subject Area revision approved (to be
  released start of FY06) that also requires an
  evaluation for noncommercial procurements over
  100K and to allow for evaluations other than the
  QAP (e.g. technical, operational).
• Several methods to performing the evaluation
• Supplier History review (documented)
• Desk-top Survey (e.g. Technical Evaluation)
• Third Party
• On-site Assessment

17
Supplier Evaluation S/A

• Supplier evaluation must be documented
• Supplier Evaluation System (SES)
• Web-based, central repository for evaluations.
• http//130.199.76.90/ppm/ses/ses.asp
• Follow-up of any deficiencies is necessary.
• For A3 and A4 risk, a supplier evaluation is
  optional (unless noncommercial gt 100K).
  Depending on the nature of the purchase and BNLs
  experience with the supplier, it may be a good
  business practice to perform some level of
  evaluation.

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Purchase Requisition Review for QA

• As part of generating a web requisition, the
  requisitioner (with the QR) selects the quality
  clauses (BNL- QA-101) that become part of the
  purchase order/contract generated by PPM. These
  requirements are flowed down to the supplier.
• The requisitioner must designate an ESHQ Risk
  Level (QA Category).
• The QA-101 should be used to define the quality
  requirements. Quality requirements be also
  clearly stated in Statement of Work, Technical
  Specification, drawings etc.
• The New CONTROL GATE
• A selection MUST be made for each req. line item.
  
• The default will be ltblankgt and No quality
  requirements necessary is a valid selection
• The QR supports the requisitioner in this process
  
• Requirements should be commensurate with the Risk
  level!

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Purchase Requisition Review for QA S/A

• The BNL QA-101 requirements are designed to
  mitigate risk and prevent quality problems while
  aiding and ensuring the requisitioner gets what
  was ordered.
• It also adds value! (calibration certs., test
  reports, ops./maintenance manuals, change
  notifications etc.)
• The completed requisition is reviewed and
  approved by the Dept/Div/Project before
  submitting to PPM.
• The Current CONTROL GATE
• Requisitions for A1, A2 items OR with a total
  value gt 25K OR PAAA space must be reviewed by
  a Quality Representative (or designee).

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The New Web Requisition
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The Web Requisition - PAAA Space
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Web Requisition Summary

• The Web Requisition is the mechanism for
  documenting and communicating quality
  requirements to PPM for flow down to the
  supplier.
• The Graded-Approach ESHQ Risk Level
• Established Requirements the Quality section
  on req.
• Prospective Suppliers Supplier Evaluation
• Requirements should be commensurate with the Risk
  level!

23
Inspections Acceptance S/A

• ALL purchased items must be inspected for
• Identity
• Count
• Depending on ESHQ Risk Level of the item,
  additional inspection and acceptance
  performance criteria may be necessary
• Documented criteria and record of inspection are
  required for A1 and A2
• Documented criteria is optional for A3, not
  required for A4
• Subject Area currently under revision
• to require IA for noncommercial items gt 100K
• regardless of risk (i.e. A3/A4)
• to require verification of A1/A2 services

• Condition
• Suspect/Counterfeit Items (if applicable)

24
Nonconformance and C/P Action S/A

• All nonconformances of purchased items or
  services that are supplier-related are reported
  using the BNL Supplier Nonconformance Reporting
  and Tracking System (BSNC) linked in the
  Nonconformance Subject Area and on the PPM
  website
• http//intranet.bnl.gov/PPM/bsnc/
• When appropriate, the responsible individual or
  designee should request documented causal
  analysis and corrective and preventive actions
  from the supplier.
• The Supplier Corrective Action Request (SCAR)
  form (located in the Corrective and Preventive
  Action Subject Area) can be used to document the
  suppliers analysis and actions.

25
Requirements Summary

• Current Internal Requirements (SBMS)
• Any Risk-Significant (A1/A2) procurement
  requires
• Supplier Evaluation N/A if O-T-S/Catalog item or
  sole source (the JNCP can be the evaluation)
• Quality Rep. review of requisition
• Documented acceptance criteria
• Record of inspection/test results
• Any Requisition gt25K OR in PAAA space
  requires
• Quality Rep. review

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Rating a Suppliers Performance

• A New Information Source (Supplier History)
• The Supplier Performance Rating System
• Report Cards are requested by PPM for all A1/A2
  and gt 100K procurements
• Request made to requisitioner/tech. rep. via
  email
• Final letter grade assigned for the PO/ contract
  based on requisitoners scoring
• http//130.199.76.90/ppm/SPRS.asp

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BNL Supplier Quality Information System
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What is the Value Added?

• Ensures the supplier is capable of providing the
  item/service you want
• Ensures you receive
• What you want (what was ordered)
• When you want it
• At a fair price (best value)
• Reduces vulnerabilities
• Improves supply base by eliminating poorest
  performers (e.g. nonconformance history and
  report cards)
• Improves Efficiencies e.g. shared Evaluations

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Procurement QA A Team Effort

• QUESTIONS ???