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1. Self-assessment culture
2. Management’s role in
self-assessment
3. Self-assessment levels to provide defense in depth
a.
Individual contributor level
b. Peer reviewer level
c. First line
supervisor level
d. Section and department level
e. Independent QA organization level - e.g., audit, surveillance,
inspection
f. Plant or
facility oversight organization level
4. Quality assessment, quality audit
and quality surveillance contrasted to self-assessment
a. Definitions of
each
b. Differences of each in terms of their requirements, objectives and
methods
c. Benefits and cautions of each
5. Process for line organization
section and department level self-assessment
a. Overview of the line
organization section and department level self-assessment process
b.
Selecting the self-assessment subject
c. Establishing the self-assessment objectives
• Effectiveness-based versus compliance-based
• Definitions of each
• Benefits and cautions of each
• Considerations in a regulatory environment
d. Establishing the self-assessment scope
• Risk-based versus non-risk-based
• Definitions of each
• Benefits and cautions of each
• Risk identification methods
• Considerations in a regulatory environment
e. Identifying the
success factors for the processes within the self-assessment scope
f. Scheduling the self-assessment
g. Selecting the self-assessment team
• Team Constituency
• Cross-functional competency
• Self-assessment process facilitator
• Team member characteristics
• Line organization ownership of the self-assessment process
• Objectivity and thoroughness
• Ethics
h. Data
Collection
• Program-based, performance-based and results-based data
• Definitions of each
• Benefits for and cautions with each
• Benchmarking
• Operating experience
• Real time observations and observation skills
• Interviewing and interviewing skills
• Records
• Status of resolution of prior issues
• Data sampling
i.
Analyzing self-assessment data
• Facts versus conclusion
• Addressing factual disagreement
• Elements of a "conclusion" statement
• "Pulling the string"
• "Rolling-up" related conclusions
• Analyzing data on a facility-wide basis - e.g., common cause
j.
Reporting self-assessment results
• Oral and written reports
• Reporting objectives
• Reporting timeliness
• Report structure
• Problem significance
• Problem ownership
• Problem entry into the corrective action process
6. Periodic, independent
oversight of the Self-Assessment Program
7. Self-Assessment Program
written policies and procedures
8. Quantitative Performance
Indicators (QPIs)
a.
Definitions of terms
b.
Objectives of QPIs
c. Criteria
for the selection and use of QPIs
d. Hierarchy
of QPIs - leading and lagging QPIs
e. Types of
QPIs - absolute and index
f.
Criteria for the establishment of corrective action thresholds
g. Groupings
of QPIs for various functions
• QPIs unique to the design engineering function
• QPIs unique to the procurement function
• QPIs unique to the operations function
• QPIs unique to the field work planning function
• QPIs unique to the maintenance function
• QPIs applicable to all functions - e.g., safety, environment
h.
Descriptions of the QPIs in each group
i.
Examples of periodic reports derived from QPIs
Note: Literally, dozens of QPIs
will be described with their rationale and formulae.
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