NP 20-2, Scientific Notebooks Training

1. NP 20-2, Scientific Notebooks Training Sandia National Laboratories Carlsbad Programs Group

2. Where Does SNL QA Program Requirements Come From? • Quality Assurance Program Document (QAPD) • Introduction: States, the purpose of the QAPD is to describe the applicability and requirements of the CBFO QA program as applied within the CBFO management infrastructure…includes all CBFO program participants (e.g. Sandia National Laboratories (SNL)) as Science Advisor.

3. Where Does SNL QA Program Requirements Come From? • Quality Assurance Program Document (QAPD) • Table I – 1, “QA Program Source Documents”, Subtitle – “Major Regulatory Requirements Documents”, Identify among other requirements: • 40 CFR Part 191 and 40 CFR Part 194 • ASME NQA – 1, 2 (Part 2.7) and 3

4. Where Does SNL QA Program Requirements Come From? • 40 CFR Part 194, Requires CBFO, SNL and other WIPP participants to comply with ASME NQA-1, 2 and 3 as applicable to perform their quality related WIPP activities. • ASME NQA-1, spells out the basic QA program element. • ASME NQA-3, spells out the QA program requirements for “Collection of Scientific and Technical Information for Site Characterization.

5. Scientific Notebooks ...are intended to be used to record information associated with research, data collection, prototyping, new methodologies, or other non-routine activities typically conducted in laboratory or field activities. In addition, SNs are to provide adequate documentation to retrace the investigation, confirm results, and to repeat the investigation and achieve comparable results.

6. Definitions • Instrument Logbook • Is a record of the use and maintenance of a specific instrument. • Scientific Notebook Coordinator (SNC) • Is the person assigned by the Technical Manager to issue SNs to the PI, and maintain the SND. • Scientific Notebook Database (SND) • Is a database used to provide information on the status of SNs. The SNC assures the accuracy and currency of the SND. • Scientific Notebook Supplement (SNS) • Is a record or collection of records created while conducting work covered in the SN that cannot be conveniently included in the SN. A SNS may be a loose-leaf binder.

7. First! Make sure you have completed your Qualification and Training form (NP 2-1-1) which includes this training before you ever write in a notebook! In addition be sure any new authorized personnel designated to make entries in your SN completes this training.

8. Second! PI contacts the SNC for the assignment of a SN, and informs the SNC of the required review frequency. The SNC will track the initiation, reviews performed, and the closure of the SN in the SND.

9. Organization The organizational requirements are contained in Appendix A of NP 20-2 and are designed to improve the quality and consistency of notebook documentation.

10. In General… All information in a SN shall relate to a single research project • You may want to segregate research activities into separate notebooks. • Entries shall be recorded in the SN, preferably on the day the work is performed in order to prevent any loss of information. If not the entry must display the date of the entry as well as the date of work performance.

11. Format, Entry & Protectionfor all SNs… • use a bound notebook with consecutively numbered pages • all entries shall be permanent, black or dark blue ink • if corrections are substantial (e.g. a paragraph or larger), an explanation shall be provided

12. Format, Entry & Protection (cont.)… • areas or pages left blank shall have a line drawn diagonally through the blank area with the individual’s initials and date • handling and storage of a SN is the responsibility of the PI and all authorized users

13. SN IntroductionShall Include • unique scientific notebook identifying number • initiation date • table of contents • work activity title • principal investigator • reference to associated Test Plan or other approved planning document

14. SN IntroductionShall Include (cont.)… • clear statement of work objectives • A reference specifying whether the starting SN is a continuation of another SN and document the label from the previous SN • A list of names of authorized users with a sample of each users printed name, signature, and initials • QA and technical review frequency statements • Acronym list

15. The Body of the SN Will Contain the Following Information… • for each research activity there shall be • a description of work, • list of materials and apparatus, • and results • description of the experimental or measurement system and process

16. Body of the SN Will Contain the Following Information (cont.)… • description of required environmental conditions (for example, documentation of each instance where and when an oven was used, and that the specific temp. record for the oven can be found in the “Temperature Logbook”) • listing or reference to data supplied by others • pasted material shall be labeled with the unique SN identifier and the page number where the document is inserted

17. M&TE DocumentationShall Contain… • Identification of measuring and test equipment used,including serial numbers • Calibrations and/or calibration checks including the acceptance/tolerance limits • Maintenance performed, anomalies observed, or analytical problems encountered during data collection (NP 12-1)

18. Daily Activity Documentation Shall Contain… • a detailed description of the work performed, observations made, and the results obtained • identification of the method(s), procedures used • a description of changes made to methods used, as appropriate • a description of the potential sources of uncertainty and error identification of samples • a signature or initials of individual performing the activity

19. Sample/Standard/Reagent Preparation Shall Contain… • a unique identification of samples • Identification of manufacturer name, lot number, expiration date (if applicable) of chemicals used to prepare samples and standard materials (used for instrument calibration or calibration check) • a unique identification for the standard material generated. It must be labeled to show the date, initials of preparer, the SN identifier where their preparation is recorded to ensure traceability (NP 13-1)

20. Sample/Standard/Reagent Preparation Shall Contain (cont.)… • the dilutions made to create a series of calibration or check standards • any dilutions made to a sample that exceeded the calibration range

21. Sample/Standard/Reagent Definitions • Sample: A sample is a physical representative part of a whole or population whose properties are studied to gain information that can be inferred to provide information about the whole or population. (NP 13-1)

22. Sample/Standard/Reagent Definitions • Standard: A sample containing analytes of known parameters specifically intended for the calibration or calibration check of the instruments. Note: it is recommended to use at least 3 standards that will cover the range of expected measurements. (NP 13-1)

23. Sample/Standard/Reagent Definitions • Calibration: A calibration is a set of operations which establish, under specific conditions, the relationship between values indicated by a measuring instrument or measuring system, and the corresponding standard or known values derived from the standard. (NP 13-1)

24. Sample/Standard/Reagent Definitions • Calibration Check: A calibration check verifies that an instrument is calibrated. A calibration check is a set of operations which verify, under specific conditions, the agreement between values indicated by a measuring instrument or measuring system, and the corresponding standard or known values derived from the standard. (NP 13-1)

25. Corrections Follow NP 17-1(Records) • All changes shall include initials or signature and the date of the correction • All mistakes shall be lined-through, initialed, and dated

26. Notebook Security • The PI is responsible for the security of the SN until its submission to the WIPP Records Center • The DRC shall be submitted to the WIPP Records Center after each technical and QA review.

27. Signatures, Initials, & Dates • Every block of daily entries should be dated. • If a day’s entries exceed a page then each page should be dated • Each block of entries performed by one individual should be initialed or signed and dated • Each page of work should be reviewed for clarity, accuracy, and quality control by the PI and signed and dated at the time of the review (Laboratory SN only)

28. Cross-Referencing • A series of related research activities may have a single written description, such as a method, that may be subsequently referenced using page numbers • Each SN should be self-contained • If cross-referencing between SNs becomes necessary, a short paragraph should be included

29. Cross-Referencing (cont.) • It is permissible to reference other notebooks that are primarily a logbook • balance calibrations • temperature logs • etc. • And supporting documentation

30. Scientific Notebook Supplement • Computer outputs • Photographs • Digital images • Magnetic media • Etc. • May be organized in a ring-binder, etc. • Must be cross-referenced in the SN, and vice versa the Supplement must cross reference the SN

31. Technical & QA Reviews • SN and supporting documentation must be reviewed…. • to verify that the work is REPRODUCIBLE and TRACEABLE • to verify the TP and associated procedures (NPs/SPs) were followed • Frequency of review is determined by the PI or Technical Manager, but at a minimum must be reviewed every 6 months and will be documented in the SN • the SNC will maintain the frequency in the SND

32. Technical & QA Reviews (cont.) • The technical and QA reviewers shall follow NP 6-1, Document Review Process, and use the associated Document Review and Comment (DRC) Form NP 6-1-1 • It is preferable that resolution should occur between the reviewer and the author before the continuation of a research activity, however, the research activity may continue if review comments do not impact the quality of the work being performed

33. Technical & QA Reviews (cont.) • The reviewer will as applicable list any supplemental binders or logbooks reviewed as part of the review on the DRC • The use of Technical and QA checklists for field and laboratory SN reviews is not mandatory but is available for guidance for the requirements and criteria outlined in this procedure to complete the review • The technical and QA reviewers shall document in the SN that reviews were performed, what part(s) of the notebook(s) were reviewed, and that all comments were resolved • The completion of reviews shall be recorded in the SN followed by reviewer’s signatures and in the SND by the SNC

34. Closure of Notebooks • A brief wrap-up statement summarizing results • A more detailed summary of results and reference(s) to related reports or papers may be included

35. Closure of Notebooks (cont.) • Indicate if a new SN will be opened and identify the next SN by label. • All remaining blank pages should be crossed-out initialed and dated to prevent further entry or a statement made that no more technical entries will be made in this SN.

36. Closure of Notebooks (cont.) • The final SN entry shall be followed by • final reviews (technical & QA) • printed names (PI & reviewers) • Signatures (PI & reviewers) • Date • PI is responsible for submitting SN and all supporting documentation to records • If a PI departs before a SN is complete, a review shall be performed and comment resolution completed. If this cannot be achieved a new PI will be identified and the SN responsibility will be transferred to the new PI

37. Records SN and supporting documentation are to be prepared and submitted to records as per NP 17-1, Records, to include the records identified inNP 20-2, Section 3.0.

38. The End You are now trained. Go forth and record data!