operation managements


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analysis and optimizations recommendations of a document center

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  • This is the DDC Process. ・ CRA promptly submits received Regulatory Documents. Received documents will be recorded in tracking system and be filed in the GCP storage room. ・ Regulatory Documents will be managed in accordance with Quintiles Global SOP. ・ Core Regulatory Documents will be tracked by Quintiles Global standard tracking system. ・ Documents will be PDF formatted, reviewed and stored by using Quintiles Global Standard Document Management System.
  • Notes/Legend: Dashed borders indicate the step has yet to be implemented (step #5). For steps 5 & 6, future plans are to place those functions in the long-term storage area when readied for workspace occupancy (i.e. climate control upgrades). To clarify, step #6 has been implemented but plans are to move the location of the function into the long-term storage area. If arrow or location is indicated in red; meaning is it is a shared location for multiple steps. Steps can be located in two separate areas as indicated.
  • operation managements

    1. 1. Quintiles: Streamlining Document Storage <ul><li>Johan Westblad | Ben Schafer | Ian Wakefield | Genki Shiohara | John Zambrano | Lance Shields </li></ul>
    2. 2. Study Objectives <ul><li>Quintiles (HQ, Research Triangle Park, North Carolina) </li></ul><ul><ul><li>World’s largest Contract Research Organization (CRO) </li></ul></ul><ul><ul><li>Conducts clinical trials for pharmaceutical and biotechnology companies </li></ul></ul><ul><li>Data and Document Center opened Aug 2008 in Tokyo </li></ul><ul><ul><li>Receives, verifies, digitize and files regulatory documents from clinical trial sites (hospitals and clinics) in Japan </li></ul></ul><ul><ul><li>Established to improve patient monitoring performance by separating collection & management of documents from CRA tasks </li></ul></ul><ul><ul><li>Current workload and capacity: </li></ul></ul><ul><ul><ul><li>17 clinical trials, 7500 documents/month, 9 staff </li></ul></ul></ul><ul><li>The issues: </li></ul><ul><ul><li>Achieve balance of cost - capacity </li></ul></ul><ul><ul><li>Create a process flow to meet future increase of workload ( doubling of projects by year end) </li></ul></ul><ul><ul><li>Minimize loss of regulatory documents </li></ul></ul><ul><ul><li>Create a layout/storage plan which can be effective over coming 2 years </li></ul></ul>
    3. 3. Presentation Outline <ul><li>Study Objectives </li></ul><ul><li>Process Mapping </li></ul><ul><ul><li>Understand the Process </li></ul></ul><ul><li>Process Evaluation </li></ul><ul><ul><li>Measure the Existing/New Document Process </li></ul></ul><ul><li>Process Improvement / Optimization </li></ul><ul><ul><li>Mathematical Breakdown/Analysis </li></ul></ul><ul><li>Qualitative data </li></ul><ul><ul><li>Interviews with staff </li></ul></ul><ul><li>Recommendations </li></ul>
    4. 4. Complete Process Overview <ul><li>Documents from Tokyo, Osaka and Fukuoka hospitals sent to CTA Center </li></ul><ul><li>CTA center sorts them, creates data base entry for each of them and sticks bar code to each of them </li></ul><ul><li>CTAs sends document batches daily to Document Center for filing (Tokyo documents received in 3 times daily:10.30-13.00 and 16.00. Osaka-Fukuoka 9.00) </li></ul>
    5. 5. Data Document Center Process Office GCP Storage Room Data Document Center Investigational Sites Record Review Room Sponsors Document Management System CTA Receive Site Regulatory Documents CRA Validate received documents Bar-coding, document IDs, tracking logs, packing in Quintiles delivery boxes, and ship to the Data Document Center via Nittsu express delivery system. ELVIS Record Center Imaging Document Tracking First Delivery and Feed back Filing Review Document Review (QC) Review Delivery Global System Standard Filing Plan of Quintiles SOP Filing Review Automatic Register
    6. 6. Operations – General Orientation Office area work stations (typical) Work stations (warehouse –like area) Long-term file storage (warehouse-like area) File Delivery Elevator Temporary File Storage (cart) Lounge & Work Area
    7. 7. Operational Steps & Spatial Layout 1 2 3 4 5 6 7 8 9 Document Reception Validation 1 Validation 2 Imaging GCP Log SSU (database) CSR (excel) Imaging Quality Check Filing 2 1 4 6 3 6 5 7 8 9 3 5
    8. 8. Process in Document Center <ul><li>Total 9 operation </li></ul><ul><li>GCP stopped because of lack of personnel </li></ul><ul><li>After Validation 1 each document is sorted by project in a WIP temporary folder </li></ul><ul><li>Each batch is returned to the WIP temporary folder after each operation </li></ul><ul><li>Documents are filed when the temporary folder is full </li></ul><ul><li>No data about Image re-scans needed </li></ul><ul><li>No data about return of documents to CTA center </li></ul>
    9. 9. Process Capacity <ul><li>Flow Rate= 240 documents/day Flow Time = 7 min. Using Little’s Law Inventory = FTxFR = 240x6.8=1632 documents </li></ul>0.9 0.4 0.7 1 (0.2) 3 n/a 0.7 0.2 Avg. Man-hour Time/doc [min] 533 1800 343 240 - 320 4800 686 2400 Capacity (pool) [doc/working day] 1 1 0.5 0.5 - 2 1 1 1 Resources/operation 4 3 1 1 n/a 4 4 3 3 Resources Filing 9 Imaging Quality Check 8 CSR (excel) 7 SSU (database) 6 GCP log 5 Imaging 4 Validation2 3 Validation1 2 Document reception 1 Process #
    10. 10. Capacity Sensitivity Analysis <ul><li>Capacity needs to be increased to deal with future increase in documents </li></ul><ul><li>Increase resources  increase FR  Increase inventory  Increase possibility of loosing documents while FT remains constant at = 6.8 min </li></ul>240 320 480 553 686 1632 2176 3264 3627 4663 Daily Capacity
    11. 11. Process Bottleneck <ul><li>SSU and CSR are the process bottleneck </li></ul><ul><ul><li>Done by only 1 person </li></ul></ul><ul><ul><li>Needs to manually enter documents’ data to the online database (SSU) and document center excel sheet (CSR) </li></ul></ul><ul><ul><li>CSR not scalable (excel sheet does not allow multiple users) </li></ul></ul><ul><li> Need in-house data base to substitute excel sheet </li></ul>
    12. 12. Clerical Staff Interviews (1) <ul><li>Currently 3 people can do about 300-400 documents per day. If there are more than 400, they don’t have time for task 8 (Imaging QC) </li></ul><ul><li>The current IT system’s don’t have enough capacity so it takes time to open documents and documents can not be viewed by more than one person at a time. If there are many documents there are more documents that require corrections the overall the whole process slows </li></ul><ul><li>At least 1 year CRA experience is needed to make a good judgment for the validation 1 and also speed up the process. When we are busy, we make more errors. </li></ul>Document Reception Validation 1 Validation 2 Imaging ( pdf ) GCP ( barcode re - scan ) SSU ( Data base doc info entry ) CSR ( Excel doc info entry ) Image QC Filing Quality OK ? Barcode ok ? Yes No Yes No Docs readable ? Call / Return to CTA Call / Return to CTA Yes No 1 2 3 WIP WIP WIP WIP 4 5 6 7 8 9
    13. 13. Clerical Staff Interviews (2) <ul><li>Creating pdf can take up to 1 day. Everyone does work the same way. Approximately 10 batches/day. They are currently 4 persons and one of them is sick. (Not work related sickness). Currently they are doing about 10hrs of OT a week to compensate for sick member and workload. </li></ul><ul><li>Also for scanning it would be more efficient if all projects can shift to Elvis as some projects that are not by Elvis need to use separate servers. Currently 4 computers are for other server projects and 3 computers for Elvis. About 70% are now old projects. </li></ul><ul><li>Currently they do bar coding at desk. Scanning is done only in the scan-room. The desks in the scanning room are very small as to prevent loss of documents, with not too many documents lying around. However, it is a problem with not having space to put the documents. </li></ul>Document Reception Validation 1 Validation 2 Imaging ( pdf ) GCP ( barcode re - scan ) SSU ( Data base doc info entry ) CSR ( Excel doc info entry ) Image QC Filing Quality OK ? Barcode ok ? Yes No Yes No Docs readable ? Call / Return to CTA Call / Return to CTA Yes No 1 2 3 WIP WIP WIP WIP 4 5 6 7 8 9
    14. 14. Clerical Staff Interviews-(3) <ul><li>The tendency to shifting so that more work will be done in the GCP storage area. One could possibly make another room inside the GCP area which could have temperature control etc. Now there is only one cooler in the room. The GCP is not currently set up for work so I do most of my work back at my desk. </li></ul><ul><li>You loose them (documents) if you sit at your desk and use them </li></ul><ul><li>Until now we haven’t shared much work with each other. We need to communicated more and cover for each other. I am working to improve the communication which I am doing on my own initiative. </li></ul>Document Reception Validation 1 Validation 2 Imaging ( pdf ) GCP ( barcode re - scan ) SSU ( Data base doc info entry ) CSR ( Excel doc info entry ) Image QC Filing Quality OK ? Barcode ok ? Yes No Yes No Docs readable ? Call / Return to CTA Call / Return to CTA Yes No 1 2 3 WIP WIP WIP WIP 4 5 6 7 8 9
    15. 15. Internal Recommendations (1) <ul><li>Before CTS sends the documents to the respective document centers, they should check to see if all of them have barcodes (this will eliminate the need for Validation 1) </li></ul><ul><li>After checking for barcodes, CTS staff should also check to see if there are any markings, tears, etc. that would make the document unacceptable (this will eliminate Validation 2) </li></ul><ul><li>By increasing staff (1 or 2 employees max) to complete these checks at the CTS level, Quintiles will save valuable time and more importantly shipping costs that are incurred between CTS and the document centers. </li></ul>
    16. 16. Internal Recommendations (2) <ul><li>Use wireless scanners to scan each document before each step in order to track the progress of each document along the process. If a document is lost, employees can track the document to a specific step along the process. </li></ul><ul><li>Scanning the document ID information into a database (project ID, hospital, doctor, etc.) will be difficult according to Management at Quintiles, but manual input of each document’s features is time consuming and prone to human error. In the future, software should be implemented in which the document’s details are input into a database at the CTS level, and they can simply be scanned at the Document Center to ensure that they have been received. </li></ul><ul><li>The current bottleneck is step 6. Resources should be increased dramatically at this stage so this manual and timely process can be done more quickly, and more documents can be filed daily. In order to do this, 2 additional Quintiles staff should be allocated to this stage, and they should move from excel to a database in which multiple users can access and input information simultaneously. </li></ul>
    17. 17. External Recommendations (Hospitals) <ul><li>Integrate the hospitals’ and Quintiles record keeping system. The hospitals surely have the project/clinical trial information stored electronically. If Quintiles can access this information, they may be able to avoid reentering the information at the CTS level. Perhaps hospitals can scan documents into a database before sending them to CTS. </li></ul><ul><li>Management at Quintiles informed us that many of the hospitals/doctors have different document templates on which they record their information. In addition, many clients have different filing protocol depending on project. If Quintiles can develop a unified set of forms for all hospitals/pharmaceutical companies as well as a unitary filing system, document management will be more efficient. Cross Training will also become less complicated. </li></ul><ul><li>Global database system so all branches of Quintiles worldwide can access information seamlessly. </li></ul>
    18. 18. Documents losses <ul><li>Tag each document/batch with RFID </li></ul><ul><li>Scan documents at each station with portable scanners </li></ul><ul><li>Monthly “Find the document contest” </li></ul>
    19. 19. Moral Boost <ul><li>- Rotate people through operations </li></ul><ul><li>Have music in scanner room and filing room </li></ul><ul><li>Awards to the employee who is the most efficient </li></ul>
    20. 20. Q&A <ul><li>What would you do if you were the Data Center's manager to reduce the flow time? Increase Flow rate? </li></ul><ul><li>What would you do to ensure that none of the documents get lost </li></ul><ul><li>How would you make the entire flow more productive (starting from the hospitals up to the data center)? </li></ul>