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Western Integrated Quality Assurance

Cotati City Council
January 24, 2023

Document
Western Integrated Quality Assurance
Meeting
January 24, 2023
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Cotati City Council
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Image Pro, Image Plus and Image Express
Quality Assurance Service Levels
Western’s imaging quality assurance process offers three service levels (Image Pro, Image Plus and Image Express) each designed to best meet the requirements of the content and condition of the documents in your collection. These service levels ensure the best possible image quality and accountability for documents found in most paper filing systems.

Image Pro service includes physical page counting per document before scanning with reconciliation to the actual number of scanned pages to reduce the possibility of un-detected multi-feeds (caused by previously stapled or hole punched documents) referred to in our proposal as Physical Page Counts and Page Count Reconciliation. After scanning, we visually inspect each image (referred to as 100% Visual Inspections) for quality and clarity since documents can be completely different in content and condition from one page to the next. This includes correcting skewed pages, when possible, noise line removal, page orientation and allows for adjusting brightness, contrast and gamma settings to improve readability due to certain shades of gray or color backgrounds or poor document quality for a specific page.

Image Plus service employs 100% Visual Inspections described above without Physical Page Counts and Page Count Reconciliation.

Image Express service omits page counting and visual inspections for high quality documents that are similar in content and condition (generally newer, computer generated or type written, non-stapled or very few and/or non-hole punched documents).

All service levels include accountability controls for the number of boxes, files and documents in your collection.

Each service level cost has been summarized for your evaluation based on your specifications.

Imaging Quality Assurance Service Summary
Image Pro includes: Physical Page Counts, 100% Visual Inspections and Page Count Reconciliation.

Image Plus includes: No Physical Page Counts, 100% Visual Inspections Image Express includes: No Physical Page Counts, No 100% Visual Inspections and No Page Count Reconciliation.

All Service Levels include: accountability controls for the number of boxes, file and documents in your collection.

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SOP Flowchart for Imaging

2. Pick Up at Client Site
Label boxes
Complete Transmittal List

3. Receiving at Western
Confirm T-lists / Create Imaging Tracking documents

5. Document Preparation
Confirm box and file counts. Create batches and make
documents scanner ready. Insert separator pages, record file/document page counts on Image Tracking Sheet

4. File (folder) Level Indexing
Count and record # of Files per box on Imaging Tracking Sheet. Create File and PDF Bookmark separator pages.

6. Scanning
Establish Scan Settings, Scan Documents, record captured documents and pages on the Imaging tracking sheet by batch

7. Quality Assurance
Verification of imaged files
100% Visual Inspections of Image for quality & clarity
Side by Side Document Identification – True Copy Verification Reconcile, Batch, File, PDF bookmarks, Document and Page Counts w/ Imaging Tracking Sheets.

When complete Reassemble documents.

8. Document Level Indexing
Index data from images/Table lookups/Assisted OCR

10. Media Creation / Upload
Create USB Flash Drive – Upload to the cloud or Host

11. Delivery/Storage/Destruction

9. Migration – OCR/Image Conversion
Create Text delimited, Database or XML files

1. Project Specification Meeting(s)
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SOP for Document Imaging (Files or Lab Notebooks)
The Document Imaging SOP comprises 11 steps to ensure all your documents are captured with the best possible rendering of the original employing our Image Pro - QA Service Level. Listed below is our SOP workflow followed by definitions of tasks that you will see in our proposal. For Quality purposes steps 5) Document Preparation, 6) Scanning and 7) Quality Assurance are intentionally completed by different Imaging Specialist in our department. The individual responsible for each task dates and initials the appropriate step on the individual Imaging Tracking sheet that is established in step 3) Receiving Documents at Western.

Steps 3 – 9 are recorded, initialed, and dated by the responsible Imaging Specialist on the Imaging Tracking Sheet. Steps 10 and 11 are recorded on the Imaging Project Final Check List.

Image Pro – Augmented with Side by Side Document Identification (True Copy Verification)

1. Project Specification Meeting(s) – Develop project specifications (image format, file, document and PDF bookmark separation, indexing, quality assurance measures and delivered output), proof of concept (complete sample) and proposal.

2. Pickup of Documents at Customer Site – Pack, label, and inventory boxes per specifications.

Complete Western Transmittal List identifying each box for imaging. Optionally list and total the number of files for each box.

3. Receiving of Documents at Western – Check in and create Imaging Department Order TLE25. Index each box (Western Transmittal List or boxes). Create barcoded tracking labels. Setup Imaging Tracking Sheets.

Steps 4 – 8 are repeated for each box of documents

4. File Level Indexing – Count and record the number of files or Lab Notebooks. Create File, PDF Bookmark and/or document barcoded separator pages. Record/attach counts to Imaging Tracking sheet, initial and date.

5. Document Preparation – Confirm box and file/Lab Notebook counts recorded on the Imaging Tracking Sheet. Create batches and make documents scanner ready (remove staples, bindings, taping, copying, make small receipts pages, and post it note pages, position post it notes if possible), insert separator pages (File, PDF bookmark or document), record file/document page counts to the FID20 report. Record Batch Information on the Image Tracking sheet and initial and date.

6. Scanning - Converting paper documents to digital images. Confirm batch counts to ensure all batches are processed. Record File and Document Counts on Imaging Tracking Sheet and initial and date.

7. Quality Assurance – Confirm batch totals (files/documents, PDF bookmarks and page counts), 100% Visual Inspections, Side by Side Page Identification (True Copy Verification) and Page Count Reconciliation. Confirm all control counts per box (Batches, Files, PDF bookmarks, Documents, and page counts). Record reconciled counts on Imaging Tracking sheet and date and initial 100% Visual Inspections, Side by Side Page Identification, and Page Count Reconciliation. Complete Western Scanning Verification Form, True Copy Verification, includes inserting signed Scanning Verification Form for each document as first page of each document/output PDF Image file and for each box.

When completed the documents are reassembled. Initial and date Reassembly on Imaging Tracking Sheet.

8. Document Level Indexing – Capturing data from scanned documents using any combination of data entry, table lookups from customer supplied data or assisted OCR and/or confirm barcode population.

Record the number of files/documents, pages, Initial and Date the Imaging Tracking Sheet.

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Finalize and Complete the project

9. Migration – OCR, Image Conversion, writing desired folder structures for images. Creating delimited text files, Access Databases or XML files corresponding to Images and Indexes created in Steps 4 – 8.

The Imaging Tracking Sheet is dated and initialed for each box.

10. Media Creation / Uploading – Collect all Image Tracking Sheets for the Project and confirm all control totals (Boxes, Files, PDF bookmarks, documents, and page counts. Transfer image output to media and/or uploading to host servers. The Final Check List for the Project is dated and initialed.

11. Delivery/Storage/Destruction – Return, store or destroy documents. Deliver media. The final check list for the Project is dated and initialed.

Western’s Imaging Service Definitions
Project Setup: This is a one-time activity to setup the workflow, separation, indexing and scanning specifications for this specific job. The setup includes receiving (confirming T-Lists) where boxes are checked in, Imaging department orders are created establishing Project numbers, Imaging Box Numbers along with Imaging Tracking Sheets for accountability.

Document Preparation: includes the handling of your documents out of boxes and out of file folders and other bindings: Create batches confirming and recording batch control counts (boxes, files and documents and pages), disassembly, removal of staples, bindings, rubber bands, taping, copying for fragile pages or file folder covers, small receipt handling, post it note positioning, inserting file, PDF bookmarks and document separator pages. In summary, document preparation is doing the required work to make documents scanner ready, trackable, and capable of being reassembled properly.

Physical Page Counts: This is an optional quality assurance measure used to assure all pages are captured and to reveal undetected multi-page feeds when using an automatic document fed scanner. This occurs due to pages that are hole-punched or stapled and due to different paper types (weights and sizes) found in most files. The pages are counted and recorded at the document level with batch totals for reconciliation later in the workflow.

Scanning: This defines the type of scanning we are doing for your job. The DPI (dots per inch), color format (Black & White, Grayscale or Color), ADF (automatic document feeder), single page at time, flatbed and Large Format are specified. Scanner, Image processing and quality settings are determined. Batches, Files and Documents that are captured are recorded and/or attached to the Imaging Tracking sheet for reconciliation in QA.
100% Visual Inspections: This is an optional quality assurance measure to ensure all pages are readable, oriented properly (landscape or portrait), removal of unwanted pages when single sided pages have ink bleeds, folds or doodles causing the scanner to capture the page. Re-scanning is done when needed. This option ensures the best possible rendering of the original document. The Imaging tracking sheet is dated and initialed by the QA operator completing the task.

Side by Side Document Identification (True Copy Verification): Each captured electronic page is visually compared to the physical page and identified. The content is not confirmed, the page is simply identified as being captured by salient markings on the physical page that match the electronic page. Upon confirmation, the Scanning Verification form for the specific document is signed, dated and then inserted as the first page of the document. The Imaging Tracking sheet is signed and initialed when the entire box is completed.

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Page Count Reconciliation: This is an optional quality assurance measure that works with Physical Page Counts done in document preparation. The physical page counts recorded in document preparation are compared to the actual pages scanned and if different are brought into agreement. Missing pages are inserted into the document. Unwanted pages are deleted. The final page counts are updated on the file level indexing audit report (FID20) which is attached to Imaging Tracking Sheet. The Imaging Tracking Sheet is dated, initial with the final totals of the box recorded.

Indexing (Box, File, Tab (PDF bookmarks), & Document): Data that is captured from box (Receiving Transmittal List or written on box) file folder main tabs, divider tabs in the folder or from a single document and normally is used as the image file name or populated to a database that cross-references the image file (used when importing to client’s existing ECM). The Imaging Tracking Sheet is dated, initialed and control counts recorded for File Level and Document Level indexing steps.

Reassembly: Our standard re-assembly is to place documents back in the proper file folder/binder and then back into the box they were delivered in. We do not re-staple or re-paper clip documents. Customers may have documents that require more detailed re-assembly such as re-binding (staples, paper clips and other bindings) and/or placing documents back into specific tabs and file folder fasteners. These re-assembly instructions are defined in the Project Specification Meetings and included in the proposal. The Imaging Tracking Sheet is dated and initialed by the operator completing the task.

Migration: Normally includes TIFF to PDF conversion, OCR, Image output folder structure required by the client, Custom file names, export databases, XML Files used as import files to the clients ECM (Electronic Content Management System). The Imaging Tracking Sheet is dated, and Initialed by the operator completing the activity.

Tiff to PDF Conversion: Converting the native scanned TIFF file to the Adobe PDF format. Includes writing index information to PDF standard fields and PDF custom fields. Image compression is also an option to reduce the overall storage space. These options are established in the Project Setup Meeting(s).

OCR (optical character recognition): Creating text files from recognizable fonts providing full text search capability for imaged documents as hidden text in PDF files or as separate text files corresponding to specific TIFF files determined in the Project Setup Meeting(s).

Media Creation / Uploading: Transferring and/or uploading your scanned images and indexed data to electronic media or host servers for delivery to you. We transfer images to CD, DVD, Flash drives and USB Hard Drives. The number of folders and PDF files are confirmed. A hard copy Listing of the folders and files on the media is produced and a copy is sent to client. The Imaging Project Final Report is dated and initialed by the operator completing the activity.

Delivery: Western returns the original documents and/or media with the digital images.

Storage: Optionally store the records for a designated period in one of our Secure Record Centers (South San Francisco, Newark and Sacramento and Vacaville).

Destruction: Western is instructed to destroy the original documents by the client via its Secure Destruction Service (shredding and pulping documents) after the project is completed. Western recommends storing the boxes for a minimum of 6 months before destruction to allow adequate time for you to review your new digital images.

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Western New Quality Assurance Offerings
for Imaging Projects
Lab Notebook Certification
Western now offers a new level of quality assurance for Biotech and Pharmaceutical Companies scanning Laboratory Notebooks called “Lab Notebook Certification.” Lab Notebook Certification is a procedure to ensure your Company’s compliance standards are met before Lab Notebooks are scanned and archived. Typical compliance items include:

1. Completion of the Notebook Assignment Page.

2. Completion of all signature blocks on the pre-numbered research pages for both Author and Witness, are signed and dated.

3. End of Notebook properly designated for partially completed notebooks.

4. Addition of “Page left intentionally blank” verbiage where required.

5. Addition of PDF custom page numbering so all pages in the notebook are numbered in accordance with the prenumbered research pages.

6. Addition of a signed and dated certification page as the first page of the PDF Image of the notebook.

Western will meet with you to review and document your notebook compliance requirements. When notebooks are sent to Western for scanning, we will inspect the notebooks for compliance first. Notebooks that do not comply are returned to you for correction. Notebooks that do comply are scanned and archived. Western tracks the status of each Notebook until the project is finished. This certification assures your notebooks meet your compliance standards when they are scanned and archived which is crucial to protect your research investment as well as your resulting inventions.

True Copy Certification
True Copy Certification is an optional quality assurance procedure which augments our current 100% Visual Inspection procedure. In addition to our inspection, each electronic page is compared to the physical page to ensure it has been captured. When the procedure is completed a True Copy Certification form is signed, dated, and added as the first page of the PDF Image of the document. This procedure is used when the physical records are to be destroyed or when an electronic copy for a third party requires attestation.

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