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Key steps in transforming a calibration program slideshare


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An overview of how to take a helicopter view of calibration programs and implement a step change in performance.

Published in: Engineering

Key steps in transforming a calibration program slideshare

  1. 1. Key Steps in Transforming a Calibration Program John Cummins, CPIP
  2. 2. Agenda • Maintenance & Reliability • The Perception of Calibration • Presentation Purpose • Presentation Format • Classifications • Calibration Frequency Analysis • Work Load Levelling • Work Practices • End-to-end Paperless Calibration Execution • The 8 Steps in Complete Calibration Transformation • Summary
  3. 3. Preventativ e Maintenanc e Corrective Maintenance Predictive Maintenanc e Site Maintenance Program OPR / UDt Review FMECA Equipment Performanc e Reviews MTBF Studies MaintenanceStrategy ReliabilityStrategy
  4. 4. Increased Equipment Availability Increased Production Capability Increased Output and Profit For these reasons, Maintenance and Reliability programs are treated as a key driver of the overall business goals.
  5. 5. What about Calibration? How is it viewed within your organization?
  6. 6. We do it because the regulations say we have to It’s a nuisance… calibration means equipment downtime! We contract that out, not my concern. Just part of the day to day running of the facility
  7. 7. So What? People don’t know/care about Calibration…
  8. 8. Most of all… it’s a missed opportunity
  9. 9. Increased Equipment Availability Increased Production Capability Increased Output and Profit Let’s look at this earlier slide again… What if we applied the same rigour to Calibrations as we do to our Maintenance and Reliability efforts? What would it look like? We’ll come back to this later…
  10. 10. • The aim of this presentation is to show you – based on case studies and my personal experience – the impact that a transformational calibration effort can have on your business. • The steps outlined in this presentation are by no means a complete list. However, I have found that they are the key components in achieving a step-change in performance. • Think of the steps as a menu that you can choose from, or personalize depending on the particular environment of your company or facility. • As engineering leaders within your organizations, you have the ability to ask the right questions and identify what changes will have the biggest impact. • Most importantly, I want people to realize that calibration management is a BUSINESS PROCESS, and significant rewards can be obtained for treating it as such… Purpose
  11. 11. Format Key Metric Case Studies Impact Lessons Learned
  12. 12. Classifications
  13. 13. Classifications – Critical % • The first key step I will talk about is Instrument Classification review, and the key metric in this regard is the overall % of “Critical” instrumentation. Do you know your Critical % Yes No Is it good bad? Don’t know… Good Are you sure?
  14. 14. Classifications: Case Studies
  15. 15. Classification Variation Case Study 1 0% 10% 20% 30% 40% 50% 60% 70% 80% USA 2 Puerto Rico 1 Puerto Rico 2 Puerto Rico 3 Canada USA 1 72% 56.7% 51.4% 35% 34% 33% % "Critical" Instruments – Different Sites Within Same Network 1 2 3 Commonality between sites was a clear classification decision process, tied to CPPs/CQAs
  16. 16. Classification Variation Case Study 2 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Solid Oral Dose Solid Oral Dose Post Optimization Sterile Fill/Finish Solid Oral Dose Pre Optimization Medical Devices 30.45% 39.89% 46.12% 61.34% 95.67% % Critical Instruments – 3 Different Companies / Locations
  17. 17. Classifications – The CRA Process • Some of you may know this as the CAT (Criticality Assessment Team) process… and may have experienced the perils of a subjective decision making process. Do you have a clear decision making process Yes No Don’t know…
  18. 18. Case Study – Subjectivity in the CRA Process Initiator Engineering Production AutomationValidation Safety Quality This instrument is not Critical But its on a batch record! Well its not listed as a critical alarm! The measured parameter is not a CPP I agree with production It’s critical!
  19. 19. Classification Changes
  20. 20. Impact of Classification Changes • In the Classification Variation case study, we looked at a site that had a Critical Instrument percentage of 61.34%. This was associated with an annual calibration figure of roughly 12,000. • After implementing a revised approach to classifications and calibration frequency, they had 5,844 calibrations per year, and reduced their Critical items to just 39.89% . • This was a great achievement for the facility in terms of reducing the calibration workload… but who else is affected by this drastic reduction in Critical instrumentation?
  21. 21. Investigation Process • On average, 4.5% of calibrations would experience an out of tolerance (OOT) event each year. • An investigation was required for any Critical instrument that was found to be OOT. This process involved multi disciplinary teams and several stages. Initial reporting of event and closure of calibration activity: 2 hours x 1 person = 2 hours Root Cause Analysis carried out, involving the calibration technician, production SMEs, Validation and Quality. 2 hours x 4 people = 8 hours Writing up the investigation based on the RCA 8 hours x 1 person = 8 hours Reviewing and approving the investigation report. 1.5 hours x 4 people = 6 hours
  22. 22. Investigation Process – Impact of Change Pre-Optimization 7,320 Critical Calibrations 329 Investigations 7,896 Man Hours Post-Optimization 1,753 Critical Calibrations 79 Investigations 1,896 Man Hours A reduction of 6,000 man hours a year, or 3 x FTEs
  23. 23. Classifications
  24. 24. Lessons Learned - Classifications • You must understand your critical instrument % figure, and how this figure stands up against your competition (internal / external). • You must have a CLEAR process for determining your classification path. • Classifications should be tied to tangible site knowledge (e.g. Critical assets tied to CPPs/CQAs). • Reduce your CRA approval (i.e. your criticality assessment team) to only those who need to have an input. • Look outside the calibration department to see what other areas are impacted by the calibration business process. You can underestimate the full value of a transformation effort.
  25. 25. Calibration Frequencies
  26. 26. Calibration Frequencies • Let’s look at the simple questions we should ask when we talk about Calibration Frequencies. Do I ever change my calibration frequencies? Yes No Is it based on Instrument Performance No Yes Is it planned ?
  27. 27. Calibration Frequency: Case Study
  28. 28. Calibration Frequency: Case Study Scope was determined Analysis Methodology Developed Change Control Approved Results Implemented
  29. 29. Calibration Frequencies
  30. 30. Impact of Calibration Frequency Changes Calibration FTE Headcount reduced by 25%. Annual vendor spend reduced by 33% A 50% reduction in annual calibrations was achieved for the site.
  31. 31. Impact of Calibration Frequency Changes • During an audit by the IMB (now HPRA), a portion of the change control was called into question. • As part of the risk assessment, instruments had been “grouped” together (i.e. assessed by instrument make/model). • The auditor felt that more scrutiny should have been applied at the instrument level. • A fully automated QRA was developed which specifically dealt with each instrument individually based on its risk to the process, and interval “caps” were applied based on this risk.
  32. 32. Calibration Frequencies
  33. 33. • When implementing a calibration frequency change effort, apply your analysis at the instrument level. • Use the analysis method as a tool for suggesting change rather than enforcing it. Allow SMEs with extensive process knowledge to have an input on the final changes that are implemented. • Despite the complexity of this type of project, do not be discouraged from taking it on… it can have the biggest impact to your annual workload and overall budget. Lessons Learned – Calibration Frequencies
  34. 34. Work Load Levelling
  35. 35. Do I routinely review my work load distribution? Yes No Is it fit for purpose based on my resource availability? No Yes Work Load Levelling • Here is the basic questions you should ask yourself on Work Load Levelling activity.
  36. 36. Work Load Levelling Case Study
  37. 37. 500 600 700 800 900 1000 1100 January February March April May June July August September October November December CalibrationsPerYear Before Work Load Levelling Activity Case Study – Workload Levelling
  38. 38. 500 550 600 650 700 750 800 850 900 950 1000 January February March April May June July August September October November December CalibrationsPerYear After Work Load Levelling Activity Case Study – Workload Levelling
  39. 39. Work Load Levelling
  40. 40. Impact of Work Load Levelling • Much more satisfied workforce, denoted by an improvement in the annual employee survey from 63% to 87%. • Reduction in associated Overtime and Time-in-Lieu costs, equating to over €120,000 per annum. • The department now had the ability for each team member to take on individual improvement projects, which showed savings / cost avoidances of over €90,000 within the first 3 months of implementation.
  41. 41. Work Load Levelling
  42. 42. • Ability to only pull work forward (without the need for site change controls). • PM Activity and the potential to “de-sync”, resulting in equipment downtime being more frequently requested. • Consideration for shutdown periods, holidays etc. • Vendor activity / Service Level Agreements (most will require significant advanced notice if required calibration dates change). • Biggest change in this effort was to team morale! No more “panic” months or “idle” months. Ability to take holidays with no major impact to team. Lessons Learned – Work Load Levelling
  43. 43. Work Practices
  44. 44. • “Work Practices” is an all-encompassing term that can cover a wide variety of metrics. • In essence, it means identifying and removing obstacles that prevent you / your team to operating in the most efficient manner possible. • YOU must identify the Work Practices most important to you , your department, your facility or your company. • Some examples of work practices are:  Training methodologies and programs  Work arrangements (shifts, flexi-time etc.)  Work Conditions (adequate facilities, hardware, tools etc.)  Continuous Improvement Project Programs  Reward and Recognition Programs • For the purposes of this presentation, I have chosen to discuss one small example of how changing a minor work practice had a positive effect on the future state of a calibration department. Important Note on Work Practices
  45. 45. Work Practices Case Study
  46. 46. Work Practices Case Study Temperature SOP-101 Calibration of Temperature Gauges SOP-102 Calibration of Temperature Transmitters SOP-103 Calibration of Temperature Switches SOP-106 Calibration of Temperature Loops SOP-104 Calibration of Temperature Via Handheld Ref Probe SOP-105 Calibration of Temperature Via Electronic Simulation 6 SOPs for One Measurement Type, each requiring biennial review… Also 6 learning items in a calibration technician's learning plan.
  47. 47. Work Practices Case Study Temperature SOP-101 Calibration of Temperature Section 1: Calibration of Temperature Gauges Section 2: Calibration of Temperature Transmitters Section 3: Calibration of Temperature Switches Section 4: Calibration of Temperature Via Handheld Ref Probe Section 5: Calibration of Temperature Via Electronic Simulation Section 6: Calibration of Temperature Loops
  48. 48. So What?
  49. 49. Work Practices
  50. 50. • When the process was repeated for all calibration types:  65 SOPs for Calibration were reduced to 24, reducing the required biennial reviews by 63%  The former biennial review process involved 195 signatures. Only 72 were required now.  Learning time was reduced by 20.5 man hours per technician Impact of Change in Work Practices
  51. 51. Work Practices
  52. 52. • Do not overlook what may seem like a minor / trivial change. Small changes can sometimes have a big impact… • Nobody knows your day-to-day processes (and the flaws in them) better than the people who have to follow them. Seek their advice and ask them what would they improve if they had the chance. • Reward ideation – have a program whereby Continuous Improvement efforts driven from the team are championed and celebrated. Lessons Learned – Work Practices
  53. 53. End-to-end Paperless Calibration Management
  54. 54. Do I utilize a fit-for- purpose CCMS Yes No Do I need paper to support my CCMS business process Yes No End-to-end Calibration Management • Follow the flowchart to find out if you are truly “paperless”.
  55. 55. End-to-end Paperless Calibration Management Case Study
  56. 56. Case Study: Paper-based CRA Receive TOP handover Add items to CRA template Print populated CRA template Review printed CRA with all stakeholders (6) Make required changes Re-review CRA Sign CRA Populate System of Record • 6 people involved in the process. • Involved “walking” the list multiple times before it would be signed. • Prone to disagreements and errors. • Laborious process to get calibrated assets live on the system of record and to manage thereafter. Execute Calibrations / Manage record on paper
  57. 57. Case Study: Paperless CRA Receive TOP handover Review items Populated on CCMS Make required changes electronically Approve Changes Populate System of Record (CCMS) • 3 people involve in the process (mirroring ISPE approach) • No “walking” of list involved. All changes made and approved electronically. • Clear decision path for classifications removed subjectivity. • Much more efficient system for getting calibrated assets into the system. • Removal of all paper from the process after instrument is “live” Once instrument is live, manage paperlessly throughout life-cycle
  58. 58. Paperless Calibration Management
  59. 59. • Administrative Cost reductions • Removal of instrument detail change forms. • Removal of Calibration Request Forms. • All events reported electronically. • Overdue reports contained directly on the system. • Always audit-ready. • Planning/Scheduling made easier with no requirement to print, distribute, execute, collect and file paper records. Impact: Paperless Calibration Management
  60. 60. Paperless Calibration Management
  61. 61.  The target condition (end-to-end paperless) means COMPLETELY paperless.  This is difficult to achieve, as some aspects of the calibration program (e.g. vendor calibrations) will almost always have to be based on paper record review and retention.  However, ensure you look at what other paper elements of your business process you could eliminate such as:  Shipping forms  Event forms  Investigation Forms  Calibration Labels  Project Certificates  Criticality Risk Assessment Process Lessons Learned – Paperless Cal Management
  62. 62. Evaluate Current State Set Targets and Wins Draft Your Plan Classifications Calibration Frequency Analysis Work Load Levelling Work Practices End-to-end paperless calibration execution 8 Steps in Complete Calibration Transformation
  63. 63. Optimized Classifications Frequencies based on performance Evenly Distributed Workload Work Practices that Enhance Business Operations Paperless Calibration Management After you implement a calibration transformation program, you now have key performance indicators that reflect a fully optimized business.
  64. 64. Summary • The aim of this presentation was to show you the impact that a transformational calibration effort can have on your business. • Having seen the results from the case studies, what would the impact be if you could do the same at your facility? • I hope that you will now ask the questions outlined in this presentations within your own organization, and that you endeavour to embark on your own calibration transformation journey.
  65. 65. John Cummins, CPIP