There are several things we have learned from dealing with regulated environments indifferent industries. Be very clear on what is compliance and what is not.

·      Mapping of scaled agility to reference model is surprisingly straight forward, once the lean-agile mindset is understood

·      Avoid the bear trap: Compliance elements shall always be mapped to value adding deliverables; instead of work products just produced to fulfill a requirement

·      Define clearly the deliverables (min one, and value adding) to each activity

·      Having good, automated mechanisms to prove mappings to reference models are needed to  reduce discussion time and interpretation games

·      Some reference models ask for process- and product-specific requirements -> Scope those requirements for purpose

Compliance is often a ‘negotiation game’

·       Don’t forget the human element of stakeholders and appraisers;
Understanding of ‘How we do compliance’ is often based on a long legacy of deeply engrained expectations and patterns.

·       Solution Intent and agile Design control (e.g. Emergent design, skeleton approach) requires that participants really understand what they are doing

Demonstrate compliance in small iterations based on flow’

·       Avoid ‘quality depth’ where compliance is ‘built in’ at the end of development.

·       Treat audits like a normal system demo

·       Focus on outcomes

Separate‘What shall be done’ from ‘How something is done’

·       Model only necessary steps in the process

·       Build and rely on heuristics to model the process for usage, e.g.:

o  Each activity has only one responsible role

o  Each activity has always an output

o  Activities with no inputs are very suspect

o  Deliverables(I/O) are usually used more than just once

o  Activities can be performed with different practices

·       Ensure that practices can be changed/selected easily by performers

QualityManagement System

·       Let the QMS be easily accessible and easy to use.

·       Promote transparency for each endeavor, Process instantiations need to be specialized in order to reduce waste.

·       Allow fast process changes and pilot in appropriate levels.

·       Allow process users to perform tailoring themselves in a controlled and easy way. Trust that they will do it good!

Your are not alone! Read/use available sources; e.g:

·       Software Engineering Institute:‘Scaling Agile Methods for Departments of Defense Program

·       CMMI Institute: ‘A Guide to Scrum and CMMI’

·       TIR45 from AAMI: ‘Agile practices in the development of medical device software’

Something that we have also learned is that having such a lean QMS in place helps you to get these major benefits.

first it will allow you to master complexity and to ensure compliance to various regulated requirements.

secondly and I think the most important, is that it will accelerate your transformation to towards a lean agile organization. according to feedback from our customers, they spent dramatically less discussion time to interpret safe and to ramp uptime for new hires is reduced by up to 2/3.

Third thing is that you will learn and improve relentlessly. there will be so many new learnings and having such a system in place it's very easy to track show relevant changes for every practitioner.

if you want to hear more about that or read our case studies just visit our a web page or get in contact with us. thank you so much we're staying with me till the end of this series of ‘PI planning in regulated environment.

Have a nice day and goodbye!