Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc?

rogerpenna

Involved In Discussions
#1
I am trying to create a workflow from one to another. It will be important to have this workflow, as we will have it on a BPMS system.

Having a Improvement Opportunity process "separated" from the others, doesn´t make sense. It has Ins and Outs of course. I have seen some Quality software where you create a Improvement Opportunity Record out of nothing, just giving it a name, benefit and target date.

Here are some thoughts, however, I am having some difficulty organizing them, so hope you guys can help.

IMPROVEMENT OPPORTUNITY
INs
-Management Review
-BPM Process Analysis
-Non conformity and CAPA (Audits, etc)
-Customer Feedback
-KPI Analysis
-Breakthrough or Creative Processes (Brainstorming?)

CHANGE MANAGEMENT
INs
-Improvement opportunities have been identified, typically to improve process effectiveness.
-Nonconformities within a process are identified and require corrective action.
-Conditions in the industry or company change, requiring a process to be updated.
-New processes are added which impact on existing processes, requiring changes.
-Outsourcing important processes.
-Persons in key roles leaving the organization.
-Customer requirements result in a need to change processes.
-Changes to active orders or contracts.
-Any other reason determined by management.

OUTs
-Risk Management



----------------------------

So, how do I see it.

A colaborator (usually employee or management) may identify an improvement opportunity. Colaborator will register it. If it comes from CAPA from Audit, it will automatically be registered, as imho, all Preventive Actions are a form of Improvement Opportunity.

Most improvement opportunities will already be registered following the flow of other processes. For example, a Management Review Process or a KPI Analysis. But it will be possible to start an Improvement Opportunity process from scratch too, if it comes from a brainstorm, from some BPM Analysis, etc... in these cases, collaborator may add additional documentation to support the Opportunity Change.

After registering an Improvement Opportunity, you create an Action Plan for it. With a 5W2H. What and Why already coming from the registered Improvement Opportunity.


I am trying to think WHEN Top Management should analyze and give the "go forward" with an Improvement Opportunity and it's Action Plan. In Management Review, in theory, if a Improvement Opportunity appeared, it was already discussed.
In a CAPA from a NC coming form an Audit, it usually is up to Process Owner to decide to change it.

So I am thinking that all Improvement Opportunities should go to the QMS Manager (me!), who will decide if some Improvement Opportunity and Action Plan needs to be approved by the Top Management.



Ok... now... what about CHANGE MANAGEMENT? I gather only a few of those INs may generate the need to a CHANGE MANAGEMENT?
Only when the change is SIGNIFICANT should it be formalized in a CHANGE MANAGEMENT process. What are major and minor changes should be agreed upon by the involved.


A procedure for Change Management
6.5 At a minimum, process changes shall include the steps herein:
The request for a process change shall be documented, typically in a Change Request. The justification for the change shall be recorded.
Management shall evaluate the merits of the proposed change and determine the actions necessary to address and implement the intended changes. Wherever it is deemed essential other departments will be consulted about proposed changes. This may include discussions with engineers, contractors, consultants, or other relevant parties before according approval for the proposed change.
6.6 Before authorizing the implementation of changes, the following points shall be verified;

All necessary technical, safety, security and environmental reviews are completed;
Risks and consequences identified during the review processes are addressed to the utmost satisfaction;
Proposed changes comply with regulatory and legal requirements;
Necessary approvals are obtained from the regulatory and/or legal authority wherever required;
All affected personnel are informed of the changes and adequately trained where necessary;
Documentation pertaining to changes and reviews are complete.
So, let me gather my thoughts. When an Improvement Opportunity will result in a major change in processes, it should go through a Change Management Process.
The Change Management Process, among other things, should result in a Risk Analysis (I gather it will also be an Opportunity, as it came from an Improvement Opportunity) and probably even affect any Training Management Process, by inserting Training Requirements for certain employees. If there are specific Lega and Statutory Analysis processes in the organization, they should also be affected.




I wrote this thread WHILE I was thinking into all of this.


Therefore, I will not edit the above, BUT I think maybe that part about the QMS Manager deciding if the Improvement Opportunity should be forwarded to Top Management should be somehow be linked to this (but not necessarily).



So, lets create some cases.
----------------------------------------
An Audit finds out some NC. Root Cause analysis results in Improvement Opportunity (a Preventive Action) of Department A having alignment meetings with Department B once a week.
- Action Plan is created.
- QMS Manager gives "go forward" to execute action plan. Or return it asking for better action plan, better documentation, etc.

-----------------------------------------

HR Manager notices Training Room could be improved. Better resolution projector, more chairs, etc. Cost $20 thousand.
-Action Plan is created.
-QMS Manager sends it to Top Management, as the Improvement requires budget, etc. But no Change Management is needed.

---------------------------------------

A manager finishes BPM course, thinks BPM Initiative and BPMS should be implemented in the Organization.
- Action Plan is created.
- QMS Manager notices this will create major changes in processes. Sends it back to the manager.
- Manager creates Change Management Plan
- QMS Manager forwards Improvement Opportunity PLUS Change Management Plan to Top Management, for approval.


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ukrainka85

Starting to get Involved
#2
Did you end up implementing the process and creating this linkage? Curious to see how you were able to identify minor/major changes and if your process owners have started to consistently implement against the procedure, and if there were any challenges (I am trying to implement something similar too)
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Curious to see how you were able to identify minor/major changes
I think you should not look at this in isolation.
Minor/Major (or Significant etc.) depends on what products you make, what your processes are etc. Tagging Minor or Minor also depends on what your SOP says the consequences of each tag are.
For example, the procedure @rogerpenna linked to says:
Minor changes may be made without formal control, however, the decision on what constitutes significant vs minor change must be agreed upon by those involved in the change. If a customer indicates a change is significant, this will trump any internal decision.
HTH.
 

ukrainka85

Starting to get Involved
#4
My question was more to you about your experience - what did you do to identify major/minor for your project. Did you work directly with involved teams? Did you provide recommendations? I was curious about what worked/did not work for you to implement this original idea you posted about
 

Ronen E

Problem Solver
Staff member
Moderator
#5
My question was more to you about your experience - what did you do to identify major/minor for your project. Did you work directly with involved teams? Did you provide recommendations? I was curious about what worked/did not work for you to implement this original idea you posted about
Please note that I (Ronen E, the user who responded today) am not the original poster (@rogerpenna)
My own personal experience may not be relevant to your situation - I work on medical devices.
 

ukrainka85

Starting to get Involved
#6
@Ronen E thanks for the clarification. Yes, my question was actually for @rogerpenna - " @rogerpenna Did you end up implementing the process and creating this linkage? Curious to see how you were able to identify minor/major changes and if your process owners have started to consistently implement against the procedure, and if there were any challenges (I am trying to implement something similar too)"
 
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