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Document Evaluation Process May 2005 Revision
8T8L May 2005 Revision
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Upon successful completion of this topic, you should be able to:
Describe the preparation for onsite document review Discuss the ORR/RA principle of sampling versus auditing Discuss the complete trail sampling technique Discuss good Team Member record / note keeping practices related to records review 8T8L May 2005 Revision
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Review Preparation Flow Chart
Requirements Objective Core Orders, Codes, Criteria Requirements Standards, Regulations Identification of Required Program & Processes Identification of important implementing Procedures / Policies Identification of important Systems, Structures, Components Identification of important Job Factors 8T8L May 2005 Revision
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Review of Procedures What procedures* are required?
* All documented, implementing mechanisms . . . Implement Regulatory Drivers . . . Programs and Processes . . . Implement Commitments . . . DSA/SAR / TSR / Accident assumptions; BIO / JCO / FHA, and EIS; List A/B, WSS, S/RIDs; Company / Operations Office procedures & requirements . . . Control Procedures, those not specifically required, but needed because of complexity, variability, risk, quality: Control and guide ops and activities to achieve desired outcome 8T8L May 2005 Revision
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Review of Procedures (continued)
Document Reviews do not have to be line by line copies of Order or regulatory driver, but must: Detail the mechanisms to fulfill the intent and requirements of the regulatory/contract driver . . . Detail the mechanisms and requirements to adequately control and document the activity . . . Focus on implementation . . . 8T8L May 2005 Revision
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Review of Procedures (continued)
Define the responsible individual(s) for each specified requirement . . . Be adequately communicated to and understood by those identified individuals . . . Comply with form and content guidance consistent with department and local expectations . . . 8T8L May 2005 Revision
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Programs to Control Procedure Adequacy
Review system: Procedures are adequate? V&V in the field? Configuration control: Procedures relate to systems; commitments identified? Formal change control? Adequate supervisory control: Ensure adequate implementation & performance of procedures? Issue and use procedures ensure only current revision in use? Training / Qualification and Assessment programs: Ensure procedures are adequately understood? 8T8L May 2005 Revision
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Performance Review Flow
Top Tier Requirement Performance Review Flow DOE / Operations Office Requirement Requirement Specific Contract (what) Requirements Company Policy / Procedure Manual Implementation Specific Project Procedures (how) Line Instructions Result Project Records
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Sampling Not a complete document audit . . .
Sample and expand if needed . . . Sampling may include complete vertical slice: Engineered change; USQ screening; Work package; 8T8L May 2005 Revision
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Your Notes Detailed enough to reconstruct . . .
Be able to describe the hierarchy and flow of requirements from highest directive to implementation . . . 8T8L May 2005 Revision
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Step 1 -- Preparation At the programmatic or activity level select the target document(s) for review: Which are the best indicators of the program? Which are important to: Environment, safety and health? Safeguards and security? Mission? Prioritize documents to review . . . 8T8L May 2005 Revision
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Step 1 -- Preparation (continued)
Communicate with site counterpart to determine: appropriate site documents; custodians & control mechanisms of documents. Communicate with Team: avoid duplication of review; ensure that team members are aware of documents that may affect their review, and don't assume they know. Records of Performance comply with Requirements 8T8L May 2005 Revision
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Step 2 --Document Review
Read and understand the documents . . . Determine if document contains required information, from developed criteria . . . Determine how document is controlled . . . 8T8L May 2005 Revision
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Step 2 -- Document Review (continued)
Determine if document is consistent with facility and activities: Equipment/hardware/software; Personnel; Higher tier commitment; Related programmatic and performance requirements. Records of performance comply with Requirements? 8T8L May 2005 Revision
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Step 3 -- Follow-up Check beyond the document evaluation:
Training; Controls to ensure procedures are followed; Document configuration control. Check compliance of base level standards to codes, standards, regulations . . . Consider for interview topics . . . 8T8L May 2005 Revision
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Step 4 -- Reporting In addition to the basic process reporting:
Record the information relating to the review criteria; Check reference information; Integrate information gained into observation and interview processes; Discuss conclusions with Team Members, as appropriate; Meet expected Team Report and Forms 1 and 2 format. 8T8L May 2005 Revision
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Summary… Does the documentation accurately and completely implement the requirements: Contractual? Authorization Basis? Programmatic? Performance? Is the documentation being implemented and requirements met? Is “Flow-Down” consistent, complete, and accurate? 8T8L May 2005 Revision
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