Appendix B

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<tbody>
<tr class="odd">
<td colspan="3"><img src="media/image1.wmf" /></td>
<td colspan="14"><strong>Laboratory Scientific Notebook Review
Worksheet</strong></td>
<td colspan="6"><p><strong>Form Number:</strong></p>
<p><strong>NP 20-2-1</strong></p>
<p><strong>Page 1 of ___</strong></p></td>
</tr>
<tr class="even">
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="6"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="6"><strong>Laboratory Scientific Notebook
Title:</strong></td>
<td colspan="16">     </td>
<td></td>
</tr>
<tr class="even">
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="6"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2"><strong>PI:</strong></td>
<td colspan="20">     </td>
<td></td>
</tr>
<tr class="even">
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="6"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4">     </td>
<td colspan="4"></td>
<td colspan="7"></td>
<td colspan="3"></td>
<td colspan="3">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4"><strong>Technical Reviewer Name (printed)</strong></td>
<td colspan="4"></td>
<td colspan="5"><strong>Signature</strong></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="3"><strong>Date</strong></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4"></td>
<td colspan="4"></td>
<td colspan="5"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="4">     </td>
<td colspan="4"></td>
<td colspan="7"></td>
<td colspan="3"></td>
<td colspan="3">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="4"><strong>QA Reviewer Name (printed)</strong></td>
<td colspan="4"></td>
<td colspan="5"><strong>Signature</strong></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="3"><strong>Date</strong></td>
<td></td>
</tr>
<tr class="even">
<td colspan="4"></td>
<td colspan="3"></td>
<td colspan="6"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="23"><strong>Technical Review</strong></td>
</tr>
<tr class="even">
<td colspan="8" rowspan="2"><strong>Requirements/Criteria</strong></td>
<td colspan="4"><strong>CRITERIA MET</strong></td>
<td colspan="11" rowspan="2"><strong>Comments</strong></td>
</tr>
<tr class="odd">
<td colspan="2"><strong>Yes</strong></td>
<td><strong>No</strong></td>
<td><strong>N/A</strong></td>
</tr>
<tr class="even">
<td colspan="8">1. Does the SN show the work related to one single
investigation, analysis, or project?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="odd">
<td colspan="8">2. Is there a statement of the objectives and
description of work to be performed?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="even">
<td colspan="8">3. Are there enough details regarding the work
performed, the observations made, and the results obtained to assure
reproducibility?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="odd">
<td colspan="8">4. Are the methods used clearly identified?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="even">
<td colspan="8">5. If methods, procedures, or planning documents were
modified, were the changes described appropriately?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="odd">
<td colspan="8">6. Are preliminary data used in the investigation
identified?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="even">
<td colspan="8">7. Are the manufacturer names, lot numbers, expiration
dates (if applicable) of chemicals used to prepare samples, and any
specific non-standard handling control and maintenance identified?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="odd">
<td colspan="8">8. Are all instrument anomalies and maintenance
activities observed or analytical problems encountered during data
collection clearly documented?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="even">
<td colspan="8">9. Were at least three NIST traceable standards,
covering the range of expected measurements, used for calibration? (NP
13-1 Section 2.4)</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="odd">
<td colspan="8">10. Are the experimental conditions and environmental
conditions of the laboratory documented?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="even">
<td colspan="8">11. Are potential sources of uncertainty and error in
test plans, procedures, and parameters identified?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="odd">
<td colspan="8">12. Did you check a sample of calculation?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="even">
<td colspan="8">13. Are data, tables, figures easily understood?</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
<tr class="odd">
<td colspan="8">14. Are units appropriately included (e.g. in tables,
calculations, graphs)</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="11">     </td>
</tr>
</tbody>
</table>

+---------------+------------+---+---+---+-------------+-------------+
| ![](medi      | **         |   |   |   |             | **Form      |
| a/image2.wmf) | Laboratory |   |   |   |             | Number:**   |
|               | Scientific |   |   |   |             |             |
|               | Notebook   |   |   |   |             | **NP        |
|               | Review     |   |   |   |             | 20-2-1**    |
|               | W          |   |   |   |             |             |
|               | orksheet** |   |   |   |             | **Page      |
|               |            |   |   |   |             | \_\_\_ of   |
|               |            |   |   |   |             | \_\_\_**    |
+---------------+------------+---+---+---+-------------+-------------+
| **QA Review** |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| **Requiremen  |            | * |   |   | *           |             |
| ts/Criteria** |            | * |   |   | *Comments** |             |
|               |            | C |   |   |             |             |
|               |            | R |   |   |             |             |
|               |            | I |   |   |             |             |
|               |            | T |   |   |             |             |
|               |            | E |   |   |             |             |
|               |            | R |   |   |             |             |
|               |            | I |   |   |             |             |
|               |            | A |   |   |             |             |
|               |            | M |   |   |             |             |
|               |            | E |   |   |             |             |
|               |            | T |   |   |             |             |
|               |            | * |   |   |             |             |
|               |            | * |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
|               |            | * | * | * |             |             |
|               |            | * | * | * |             |             |
|               |            | Y | N | N |             |             |
|               |            | e | o | / |             |             |
|               |            | s | * | A |             |             |
|               |            | * | * | * |             |             |
|               |            | * |   | * |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 1\. Is the SN |            |   |   |   |             |             |
| referenced in |            |   |   |   |             |             |
| the SND?      |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 2\. Have the  |            |   |   |   |             |             |
| notebook      |            |   |   |   |             |             |
| users         |            |   |   |   |             |             |
| completed the |            |   |   |   |             |             |
| Qualification |            |   |   |   |             |             |
| and Training  |            |   |   |   |             |             |
| form NP       |            |   |   |   |             |             |
| 2-1-1?        |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 3\. Have the  |            |   |   |   |             |             |
| notebook      |            |   |   |   |             |             |
| users         |            |   |   |   |             |             |
| completed the |            |   |   |   |             |             |
| training      |            |   |   |   |             |             |
| module for    |            |   |   |   |             |             |
| Scientific    |            |   |   |   |             |             |
| Notebooks     |            |   |   |   |             |             |
| procedure (NP |            |   |   |   |             |             |
| 20-2)?        |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 4\. Is the    |            |   |   |   |             |             |
| appropriate   |            |   |   |   |             |             |
| planning      |            |   |   |   |             |             |
| document      |            |   |   |   |             |             |
| (e.g. Test    |            |   |   |   |             |             |
| Plan) active? |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 5\. Is the    |            |   |   |   |             |             |
| most current  |            |   |   |   |             |             |
| version of    |            |   |   |   |             |             |
| the planning  |            |   |   |   |             |             |
| document      |            |   |   |   |             |             |
| (e.g. Test    |            |   |   |   |             |             |
| Plan) being   |            |   |   |   |             |             |
| used?         |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 6\. Is the    |            |   |   |   |             |             |
| appropriate   |            |   |   |   |             |             |
| planning      |            |   |   |   |             |             |
| document      |            |   |   |   |             |             |
| identified in |            |   |   |   |             |             |
| the SN?       |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 7\. Are the   |            |   |   |   |             |             |
| name,         |            |   |   |   |             |             |
| signature,    |            |   |   |   |             |             |
| and initials  |            |   |   |   |             |             |
| of each       |            |   |   |   |             |             |
| individual    |            |   |   |   |             |             |
| making        |            |   |   |   |             |             |
| entries in    |            |   |   |   |             |             |
| the SN        |            |   |   |   |             |             |
| documented?   |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 8\. Is the    |            |   |   |   |             |             |
| name of the   |            |   |   |   |             |             |
| responsible   |            |   |   |   |             |             |
| PI            |            |   |   |   |             |             |
| documented?   |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 9\. Are any   |            |   |   |   |             |             |
| previous      |            |   |   |   |             |             |
| and/or        |            |   |   |   |             |             |
| subsequent    |            |   |   |   |             |             |
| SNs           |            |   |   |   |             |             |
| identified    |            |   |   |   |             |             |
| and           |            |   |   |   |             |             |
| documented?   |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 10\. Are the  |            |   |   |   |             |             |
| measuring and |            |   |   |   |             |             |
| test          |            |   |   |   |             |             |
| equipment     |            |   |   |   |             |             |
| identified    |            |   |   |   |             |             |
| (including    |            |   |   |   |             |             |
| serial        |            |   |   |   |             |             |
| number)?      |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 11\. Are all  |            |   |   |   |             |             |
| the measuring |            |   |   |   |             |             |
| and test      |            |   |   |   |             |             |
| equipment     |            |   |   |   |             |             |
| calibrated or |            |   |   |   |             |             |
| checked for   |            |   |   |   |             |             |
| calibration   |            |   |   |   |             |             |
| before every  |            |   |   |   |             |             |
| use?          |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 12\. Is there |            |   |   |   |             |             |
| an indication |            |   |   |   |             |             |
| of the        |            |   |   |   |             |             |
| accepta       |            |   |   |   |             |             |
| nce/tolerance |            |   |   |   |             |             |
| limit for     |            |   |   |   |             |             |
| calibration   |            |   |   |   |             |             |
| or            |            |   |   |   |             |             |
| calibration   |            |   |   |   |             |             |
| check of each |            |   |   |   |             |             |
| instrument?   |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 13\. Are the  |            |   |   |   |             |             |
| computer      |            |   |   |   |             |             |
| programs used |            |   |   |   |             |             |
| (name,        |            |   |   |   |             |             |
| version,      |            |   |   |   |             |             |
| platform)     |            |   |   |   |             |             |
| identified?   |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 14\. Are the  |            |   |   |   |             |             |
| manufacturer  |            |   |   |   |             |             |
| names, lot    |            |   |   |   |             |             |
| numbers,      |            |   |   |   |             |             |
| expiration    |            |   |   |   |             |             |
| dates (if     |            |   |   |   |             |             |
| applicable)   |            |   |   |   |             |             |
| of chemicals  |            |   |   |   |             |             |
| used to       |            |   |   |   |             |             |
| prepare       |            |   |   |   |             |             |
| samples, and  |            |   |   |   |             |             |
| any specific  |            |   |   |   |             |             |
| non-standard  |            |   |   |   |             |             |
| handling      |            |   |   |   |             |             |
| control and   |            |   |   |   |             |             |
| maintenance   |            |   |   |   |             |             |
| identified?   |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 15\. Does     |            |   |   |   |             |             |
| each sample   |            |   |   |   |             |             |
| have a unique |            |   |   |   |             |             |
| id            |            |   |   |   |             |             |
| entification? |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 16\. If       |            |   |   |   |             |             |
| standard      |            |   |   |   |             |             |
| materials     |            |   |   |   |             |             |
| have been     |            |   |   |   |             |             |
| prepared to   |            |   |   |   |             |             |
| calibrate or  |            |   |   |   |             |             |
| check         |            |   |   |   |             |             |
| instrument    |            |   |   |   |             |             |
| calibrations, |            |   |   |   |             |             |
| does each     |            |   |   |   |             |             |
| standard used |            |   |   |   |             |             |
| to calibrate  |            |   |   |   |             |             |
| and check     |            |   |   |   |             |             |
| instrument    |            |   |   |   |             |             |
| have a unique |            |   |   |   |             |             |
| id            |            |   |   |   |             |             |
| entification? |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 17\. Are      |            |   |   |   |             |             |
| loose         |            |   |   |   |             |             |
| materials     |            |   |   |   |             |             |
| contained in  |            |   |   |   |             |             |
| the SN        |            |   |   |   |             |             |
| permanently   |            |   |   |   |             |             |
| attached      |            |   |   |   |             |             |
| inside the    |            |   |   |   |             |             |
| SN, and       |            |   |   |   |             |             |
| labeled with  |            |   |   |   |             |             |
| the SN title  |            |   |   |   |             |             |
| and page      |            |   |   |   |             |             |
| number of the |            |   |   |   |             |             |
| SN where the  |            |   |   |   |             |             |
| material is   |            |   |   |   |             |             |
| attached?     |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 18\. Are the  |            |   |   |   |             |             |
| corrections   |            |   |   |   |             |             |
| in the        |            |   |   |   |             |             |
| notebook line |            |   |   |   |             |             |
| out and       |            |   |   |   |             |             |
| initialed in  |            |   |   |   |             |             |
| accordance    |            |   |   |   |             |             |
| with NP 17-1? |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 19\. Are      |            |   |   |   |             |             |
| associated    |            |   |   |   |             |             |
| SNSs          |            |   |   |   |             |             |
| documented    |            |   |   |   |             |             |
| and           |            |   |   |   |             |             |
| identified?   |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 20\. Are all  |            |   |   |   |             |             |
| technical     |            |   |   |   |             |             |
| reviews       |            |   |   |   |             |             |
| documented on |            |   |   |   |             |             |
| a DRC?        |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 21\. Was the  |            |   |   |   |             |             |
| technical     |            |   |   |   |             |             |
| reviewer      |            |   |   |   |             |             |
| "             |            |   |   |   |             |             |
| independent"? |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+
| 22\. Is the   |            |   |   |   |             |             |
| frequency of  |            |   |   |   |             |             |
| this SN       |            |   |   |   |             |             |
| review        |            |   |   |   |             |             |
| appropriate?  |            |   |   |   |             |             |
+---------------+------------+---+---+---+-------------+-------------+