Key steps in transforming a calibration program slideshare
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Key Steps in Transforming a Calibration Program John Cummins, CPIP
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Transcript of Key steps in transforming a calibration program slideshare
Key Steps in Transforming a Calibration Program
John Cummins, CPIP
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
Preventative
Maintenance
Corrective Maintenance
Predictive Maintenanc
e
Site Maintenance
Program
OPR / UDt ReviewFMECA
Equipment Performance Reviews
MTBF Studies
Mai
nten
ance
Str
ateg
y
Reliability Strategy
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.
What about Calibration?How is it viewed within your
organization?
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
So What?
People don’t know/care about Calibration…
Most of all… it’s a missed opportunity
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…
• 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
Format
Key Metric
Case Studies
Impact
Lessons Learned
Classifications
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…
GoodAre you
sure?
Classifications: Case Studies
Classification Variation Case Study 1
USA 2
Puerto Rico 1
Puerto Rico 2
Puerto Rico 3
Canada
USA 1
0% 10% 20% 30% 40% 50% 60% 70% 80%
72.0%
56.7%
51.4%
35.0%
34.0%
33.0%
% "Critical" Instruments – Different Sites Within Same Network
1
2
3
Commonality between sites was a clear classification decision process, tied to CPPs/CQAs
Classification Variation Case Study 2
Solid Oral Dose
Solid Oral Dose Post Optimization
Sterile Fill/Finish
Solid Oral Dose Pre Optimization
Medical Devices
0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00%
30.45%
39.89%
46.12%
61.34%
95.67%
% Critical Instruments – 3 Different Companies / Locations
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…
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!
Classification Changes
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?
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 RCA8 hours x 1 person = 8 hours
Reviewing and approving the investigation report. 1.5 hours x 4 people = 6 hours
TOTAL: 24 MAN HOURS PER OOT EVENT
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
Classifications
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.
Calibration Frequencies
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
YesIs it
planned?
Calibration Frequency: Case Study
Calibration Frequency: Case Study
Scope was determined
Analysis Methodology
Developed
Change Control
Approved
Results Implemented
Calibration Frequencies
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.
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.
Calibration Frequencies
• 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
Work Load Levelling
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.
Work Load LevellingCase Study
January February March April May June July August September October November December500
600
700
800
900
1000
1100
Before Work Load Levelling Activity
Calib
ratio
ns P
er Y
ear
Case Study – Workload Levelling
January February March April May June July August September October November December500
550
600
650
700
750
800
850
900
950
1000
After Work Load Levelling Activity
Calib
ratio
ns P
er Y
ear
Case Study – Workload Levelling
Work Load Levelling
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.
Work Load Levelling
• 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
Work Practices
• “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
Work PracticesCase Study
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.
Work Practices Case Study
Temperature
SOP-101 Calibration of TemperatureSection 1: Calibration of Temperature Gauges
Section 2: Calibration of Temperature TransmittersSection 3: Calibration of Temperature Switches
Section 4: Calibration of Temperature Via Handheld Ref ProbeSection 5: Calibration of Temperature Via Electronic Simulation
Section 6: Calibration of Temperature Loops
So What?
Work Practices
• 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
Work Practices
• 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
End-to-end PaperlessCalibration Management
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”.
End-to-end PaperlessCalibration Management
Case Study
Case Study: Paper-based CRAReceive 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
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
Paperless Calibration Management
• 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
Paperless Calibration Management
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
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
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.
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.
John Cummins, [email protected]
