death by documentation - where have all the hours gone?
TRANSCRIPT
“Where have all the hours gone?”
Medical Device Development - Death by documentation?
May 2015
Aligned AG
About Aligned AG
Provider or Aligned Elements -
a Medical Device ALM
Founded in 2006 in Zürich, Switzerland
Team highly experienced in Medical
Device Development
Experts in Medical Device
Documentation Management
Aligned AG
Medical Devices and Documentation
Up to 30% of development effort
The documents are interdependent
Constant change in content
Changing regulatory landscape
Difficult to detect gaps and errors
Large potential penalties
Aligned AG
Trends and Observations
Curbs innovation velocity
“Everyone” is documenting
Continuously growing burden
People get bored and leave the company
Aligned AG
Not all documents are alike
Documentation is here to stay
A competitive dimension
Can we make it efficient?
Note: A document ALWAYS incur a cost!
Total Cost of Document
What are the drivers for increased
documentation costs?
Aligned AG
Where is the work? Example I
4%
32%
19%
45%
Requirements
Specifications
Risk Analysis
V &V
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Where is the work? Example II
21%
25%
54%
Other
Design Output
V &V
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Where is the work? Example III
Type RQ Risk Spec Test Case Test Report
Avg. # Changes 1.8 3.6 6.3 8.5 2.4
Total # Items 251 992 1652 2370 2045
Aligned AG
What causes work? Example I
Q manager 1: „Do not leave table cells empty, use dashes“
Q manager 2: “Do not use dashes in table cells, use N/A”
Q manager 3: “All N/A in table cells must be explicitly qualified”
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What causes work? Example II
References
Ref. # Document name Version
1 397884 Guideline test case template V1.1
2 01440_97555 Software tool validation plan trace matrix generator V1.3
3 01440_97556 TraceMatrixGenerator Specification Document V1.0
Aligned AG
Reasons
Reality changes
Templates/Process/People changes
Many vs. Few modifications
What can we do?
Understand the true cost of template/process changes
Reduce the risk for committing formal errors
Reduce / outsource dependencies between documents
Use automated tools to detect and correct inconsistencies
Correcting “formal” errors
Document interdependencies
Aligned AG
The more the merrier
Write
Dry run
Peer review
Q review
Tester Releases
Update TC
Overview
Dry run by other Tester
Update TC
overview
Ready for real test run
Aligned AG
Three is a crowd
Signatures per Test Case: 3
Total Number of signatures: 18000
Avg. time to collect a signature: 0.5h
Total time: 5 man-years
Aligned AG
Reasons
Interdisciplinary documents
Many stakeholders
Involves many vs. few people
What can we do?
Ask yourself: “Does this make the product safer and better?”
Reduce number of people involved
Trim down Review – Release – Sign-off procedures
Assign deputy rights
“Enforce” responsibility
Extensive workflows
Aligned AG
The extensive master template
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“One size fits all”- template
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Reasons
Fear of non-compliance (“better safe than sorry”)
Extensive master templates
“One size fits all” - templates
Content vs. Overhead in Document
What can we do?
Challenge template growth
Identify and eliminate overhead sections and actions
Allow for variation in the template
Increase the content/overhead ratio by aggregation
Aligned AG
Rigid Workflows
“I can’t sign this document before the author has signed it.”
“The review cannot start until the draft is official.”
“She can’t write the test case because she only has testing authorization, not test case writing authorization.”
“This test iteration does not start until all bugs have been assigned to a tester.”
„We cannot start until Q-manager has signed off the reqs.“
Aligned AG
Changing specifications
Common knowledge says: “Start with testing early”
The specifications are going to change
Changing specifications =>
Test changes + Additional test cycles
What shall we do? Write tests early or wait until the end?
Aligned AG
Reasons
Reality changes
Complex collaborations
Long time vs. Short time to completion
What can we do?
Wait for stabilization, “Document late” / J.I.T when you need them
Prepare for writing – set the table
Separate stable data from unstable data
Allow for variations in workflows
Allow parallel workflows
Data has not stabilized
Rigid, sequential workflows
Aligned AG
Repetitive tasks I
21%
25%
54%
Other
Design Output
V &V
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Repetitive tasks II
Monday morning:
Hi Bob,
The milestone is
coming up Friday.
Here is the 240
page document to
review!
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Reasons
Reoccurring tasks (e.g. reviews)
Design control item (e.g. Test Cases)
Unwarranted division of content
Many instance vs. few instances
What can we do?
Analyze the creation and modification process
Relentlessly eliminate unnecessary process steps
Use minimalistic templates
Focus Reviews on changes
Aggregate content where applicable
Aligned AG
The “ideal” document
Easy to write
Fast to complete
High content vs. overhead ratio
Involves few people
Does not get sent around
Few modifications
Few dependencies
Aligned AG
Administrative overhead in creation and modification of documents
Template Designers Documentation Executer
Extensive Templates (capture all info needed for any situation)
Templates that do not fit the task (“one size fits all”)
Workflows involving lots of people (tends to create bottlenecks)
Workflows with rigid order (“this can’t start until that is finished”)
“Good intentions” can have unexpected effects
Common Culprits
Aligned AG
Optimize process and templates for reoccurring doc types
Trim down the master templates
Allow for variations in templates
Allow for variation in workflows
Trim down the review-release-sign-off process
Keep interdependencies in separate documents
Use automated tools for version, change and trace management
Proposed solutions
Aligned AG
Aligned Elements – a medical device ALM
Manages the Technical Documentation
Version Control + Traceability + Documents
Integrated Risk Management
Integrated DHF Index
Reviews + Workflows + E-signatures
Automatically finds formal gaps and errors
Ensures completeness and consistency
Thank You! Aligned AG
Binzmühlstrasse 210
CH-8050 Zürich
Switzerland
t +41 (0)44 312 50 20
f +41 (0)44 312 50 20
w www.aligned.ch