Scope of work Changes with Management of Change
Do you manage change for your organization and are familiar with the The Scope of Work changing faster than the implemented design? Management of Change (MOC) takes more consensus the further down the project phase gates.
Prototypes are less regulated than systems that require Technology Readiness Level
In Regulated Industries the rules and laws for manufacturing can change, though the system designed may work, laws may change the system and the parts that make it work.
Much like the use of Mercury in Controls Systems, supply changes, systems are living and their documentation should be living as well
Management of Change
Systems that last generations are much like Theseus ship, as you replace parts they are often the same system but with improvements and new points of failures
Failure Mode Effect Analysis
Systems that require Management of Change should have a Failure Mode Effect Analysis and User Requirements List, these become the Pivot or Dynamic set of Lists that create the following waterfall of documentation:
Scope of Work
Freedom to Operate Documentation of Compliance
Functional Test Requirements (Assets)
Preventative Maintenance (Corrective and Preventative Actions against Risks to Assets)
Devices to meet user Requirements, Watch Dog Safety
There are four Types of Failure Mode Effect Analysis
User
User Failure Mode Effect Analysis (UFMEA)
Users are the Talent and Customers of your products and services
Device
Device Failure Mode Effect Analysis (DFMEA)
Devices include the Equipment that enable you to make a unique product
Process
Process Failure Mode Effect Analysis (PFMEA)
Business
Business Failure Mode Effect Analysis (BFMEA)
Some failures can lead to others, since a business requires working Processes, Users and Devices any of these can cause a risk to the business and its reputation.