A Total Solution for Semiconductor / WEEE RoHS Laboratory

Transcription

1 A Total Solution for Semiconductor / WEEE RoHS Laboratory Chamnong Ingsathit LABWORKS LIMS Territory Product Line Leader, Pacific Rim

2 Let s s look at what a LIMS can do for you Asset Management People Environment Data Quality Assurance Control and document who does what? Improved Quality of the numbers Fewer transcriptions = fewer errors Manual data processing = improved accuracy and precision Page 2

3 Let s s look at what a LIMS can do for you Automate the lab s s production pipeline Data Capture Lab Data Field and Plant Data (labor involved & improving availability to the lab) Data Processing Calculations Spec/Limit Checking Approval/Data Validation Report Generation and Submission Customer Services To a scientist To a paying customer To plant operations To finance To regulators Page 3

4 How LIMS Solves their Lab Problems? LIMS helps lab obtain Accreditation and Increase throughput Implementation of LABWORKS has helped the Portland, Oregon Bureau of Water Works obtain National Environmental Laboratory Accreditation Program (NELAP) LABWORKS has helped us increase throughput by automatically scheduling most samples and allowing field data to be collected on handheld computers and uploaded to LIMS. Alberta Seierstad, Laboratory Manager for the Portland Water Works Environmental Laboratory cuts turnaround time 50% with LIMS The Mississippi Department of Environment Quality (MSDEQ) has cut analysis turnaround time from receipt of samples to issuance of final report by 50% Page 4

5 What should a LIMS have? Meet the requirement of quality regulatory, ie ISO 17025, 21 CFR Part 11, etc. and Audit Trails Increase throughput and accuracy of data Instrument interface and integration Accelerate information feedback for faster and better decision making Prioritize work and plan for work assignment Report generation capability- Exception report, Work Pending report, etc. Ability to interface with other applications, ie ERP, etc Page 5

6 Page 6 Sample Workflow

7 Quality Improvement using LIMS

8 Quality Improvement by using LIMS for management MAINTAIN LAB PROCEDURES SECURITY ROI LOCAL LANGUAGE MANAGEMENT REPORTS FLEXIBLE & CONFIGURABLE SUPPORT DATA ACCESSABILITY Page 8

9 Quality Improvement- MAINTAIN LAB PROCEDURES For laboratories that is certified for ISO 9000 or 17025, LABWORKS enable ensures that system is adhered to. Example:» What are the procedures for test and sample approval?» What are the procedures for instrument calibrations?» Analyst certifications?» Data tracking? Whose action at what time?» Fast reporting using correct reports formats. Page 9

10 Page 10 Sample Scheduling- Calendar View

11 PDET & PDET CE Portable Data Entry Terminal A hand held device with barcode reader provides a portable remote sample collection and data recording terminal. The reader is programmed to display LIMS forms. Responses may be scanned from bar-coded labels or worksheets, or manual entry is made by using the keyboard or Character recognition. LIMS routines pre-program the Device to collect data and automatically read the time and date stamped entries. Automatic results entries are a snap. Page 11

12 Quality Improvement via Instruments Interface Most LIMS can Interface Instruments What you need is much MORE!!!! Brings in results files like everyone else Populates Sequence files for positive sample ID Saves spectra and chromatograms for reports Saves Raw data file for later reprocessing Saves Final reports as PDF file Saves instrument method files, calibrations, etc. Page 12

13 Sample Data Entry Analysis results Instrument data entry Page 13

14 Sample Data Entry Supplementary analysis information Raw Data, Chromatograms/Spectrums, etc. Page 14

15 Quality Improvement via Seamless Calculations embedded Page 15

16 Page 16 Quality Improvement via viewing your SOP anytime anywhere

17 ROI Return On Investments A lab with 2 chemists, 3 lab analysts and 1 admin clerk could potentially save up to USD30,000 a year! This is based on the amount of repetitive and duplicate work that can be avoided. The time saved ensures that chemists and lab analysts spend more of their time doing analysis or R&D work rather than paper work. The calculation does not take into account subjective benefits such as reduction or errors, increased work satisfaction, increased customer satisfaction etc. Page 17

18 What can I expect for ROI? Cost Savings Take it out of current process Vs. Cost Avoidance What I don t t have to pay for in the future. Objective Measurable to the bottom line. Subjective Not directly responsible for bottom line savings. Page 18

19 Cost Avoidance What are the intangible benefits of LIMS? Often more significant but difficult to measure The cost of poor data quality in industry Returned product Disappointed customers Regulatory issues (WEEE/RoHS RoHS,, FDA, EPA, etc.) Measuring quality problems Cost of marketing and advertising to win back customers Cost of compliance violations in lab and manufacturing practices (WEEE/RoHS RoHS,, FDA etc.) Cost due to lack of adaptability to new processes Page 19

20 In the Lab Sample Lifecycle Analysis How much time can be saved at each discreet step? Page 20

21 Sample Login ¾ Single Samples Little time saved but eliminates need to transcribe data later on. ¾ Routine Scheduled Samples Significant savings after the initial setup Example: 2 minute per sample X 100 samples/day = 3.33 hours! Page 21

22 Test Assignment by Supervisor Assign work by backlog priority, instrument and personnel availability Significant savings opportunity Instrument sequence setup Potential elimination with smart integration Page 22

23 Data Entry Data Capture = manual vs. automated Calculations and Processing Could eliminate minutes of time per sample Page 23

24 Review/Approve Checking results entry for errors Checking calculations for errors Limit checking Specification checking Integrity of automated capture and processing is significant Page 24

25 Reporting Time to generate each type of report Time to generate COA s and other types of reports Invoicing Project Summaries Reports necessary for operations Time spent delivering a report Page 25

26 Customer Services Time spent providing customer services Looking up status/results vs. automated deliveries or customer access Page 26

27 Laboratory Management Summary Repts. Time spent looking up statuses. Time spent performing current asset management tasks. Page 27

28 Case Scenario QC Lab 6500 samples 43,000 tests 21,500 tests require calculation Productivity Assessment (Average minutes per sample) Function Current Operation With new LIMS Savings (min. per sample) Sample Login Assignment of Tests Data Processing/Calculations Verify Calculations Test Validation Approve/Report Total 46.8 Total man hours saved at 6,500 samples/year= 5,200 hours Page 28

29 Case Scenario QC Lab Without LIMS one sample takes 76.3 mins With New LIMS one sample takes 29.5 mins 61.5% increase in time consumption Page 29

30 Cost savings outside the lab Measuring Labor for transferring data to another system Measuring time to organize lab data with non-lab data E.g. Certificates of Analysis generation Matching batch/lot quality to customer specs The value of improved turnaround times Reduction of cost in inventories Eliminating time out of the manufacturing process Eliminating time out of the R&D process What is time to market worth? Page 30

31 Case Scenario & Results LIMS installed in 3 plants Analyzed... - Lab productivity-turnaround turnaround time - Raw material storage - Work in progress inventory Produced a productivity matrix for their sample flow Savings at Plant: 7,532 hours/year Reduced Cycle Times 2 Days (from 50 to 48) Working Capital Reductions $50M of raw materials = $137,000 per day 2 day elimination saves $68,500 in cycle Work in Progress Reductions Reduced time for Manufacturing QC by 2 days $198,650 in savings Page 31

32 Consider Cost of Ownership Is your old LIMS worth keeping? Identify cost of ownership comparisons IT Systems and staffing costs Servers Software Maintenance Eg.. Installing new revisions on Current Maintenance Costs Software Support Consulting Services (even for a migration) Page 32

33 Summary Look at both tangibles and intangibles Quantitate the time savings in each lab process Quantitate the sample turnaround time savings Every lab is different with different opportunities for improvement ent Consider the impact on the Enterprise that you serve The best reasons for a LIMS may be your services to them Utilize you finance resources to solidify your ROI determination Page 33

34 Quality Improvement - SECURITY Enhanced Security! Helps customers develop a more efficient paperless business process Helps customers meet 21 CFR Part 11 requirements Provides electronic signature and audit trail capabilities Single centralized point of authentication Easier to install and manage Not just for Pharma! Several product enhancements beyond 21 CFR 11 requirements Other industries such as environmental and forensic laboratories are beginning to adopt the methods spelled out in the 21 CFR Part 11 regulations Page 34

35 Quality Improvement - Reports Ability to generate reports in Microsoft Word, Excel, Access or Crystal Reports Choose the tool that is most suitable for the job! Page 35

36 Page 36 Quality Improvement Automated Management Reports

37 Quality Improvement SQC Charts made easy 2 of 3 above 2/3 of UCL Page 37

38 Quality Improvement Exception Reports looking for problems Exception reports inform users of samples with parameters that are out of specifications Exception reports can also be set to automatically generated and ed to user. Page 38

39 Quality Improvement Data Access (web based) Results can be checked and printed through the internet Page 39

40 Quality Improvement Data Access (LAN) On-line real-time review of laboratory data Page 40

41 Quality Improvement Process Scheduler (view by Samples) Viewing by sample allows user to have an overview of current lab status Page 41

42 Quality Improvement Flexible & Configurable Fast implementation because it is off the shelf product. But software designed to be configurable to various user needs. Users on service plans gets software updated whenever available. New modules can be implemented base on industry best practices. Any changes on the database or operation logic happens without daily user noticing LOW retraining cost. Page 42

43 Quality Improvement - Support Support by local office- SEIN InfoTech. 24/7 support based on or phone. Users on annual support would be entitled to all new upgrades, revision or patches being released. Unlike normal software companies (custom made) that are interested in a single sales process,, off-the the-shelf LIMS would always maintain a high level of support because of the long term commitment and continuing product improvement to the laboratory customers. Page 43

44 Get Information to YOUR Customers LABWORKS offers some of the most advanced report writing capabilities on the market. Seamless Interfaces to: MS Word Excel Access Crystal And automates the reporting process: Automatic Trend Graphs Automated Exception Reports Automated Final Reports Certificates of Analysis Industrial Pretreatment Reports Access Reporting Word Reporting Page 44

45 Get Information to YOUR Customers Customer Specific COA s Page 45

46 Page 46 Quality Improvement by LIMS for management

47 Manage your assets Laboratory Staff Certifications Instrument Certifications and Calibration Page 47

48 Laboratory Staff Certifications- Personnel Training Module Who is qualified? What are they qualified on? Page 48

49 Instrument Certifications and Calibration When are they due for calibration or preventative maintenance? Who did the maintenance? What samples/standards were used in the maintenance? Page 49

50 Who Uses LIMS? Broad LIMS usage Today Process Control Chemical/ Electronic / Petrochemical Environmental Water/Wastewater Pharmaceutical Power Utilities Food /Agriculture Water & Wastewater Environmental Process Control Agriculture Utilities Page 50

51 Page 51 Who Uses LABWORKS? Some Customers

52 Key LIMS Selection Criteria Easy to install, easy-to to-use Instruments interface capability History of the LIMS vendor Totally configurable LIMS no customization needed Future proof $$$$ Page 52

53 LIMS- A solution for modern lab management A valuable resource for any laboratory, large or small, public or private Allows lab managers to spend more time directing day-to to-day operation of a laboratory without having to worry about sample and data integrity Makes a lab analyst s s duties more efficient Allows the labs customers to be confident in the quality of the data for their samples Page 53

54 Page 54 Question & Answer