Change Control in a SCRUM World

C

christyK

#1
I just started a new position and I have been tasked with reviving the CCB (change control board) process. I come from medical devices and we had a very lengthy CCB there and it included new and changed products and processes. However, that doesn't quite fit for my new company which develops websites, databases, and data reports for Clients. They use Scrum here (or at least try). When I created the project charter and sat down with my boss, he thought it sounded a lot more like Scrum and didn't want to compete. I think he wants CCB to be more improvement oriented. I am thinking that the CCB process can be non-customer initiated changes, whereas all other changes are handled in SCRUM.

Anyone have experience with this and willing to share the differences in your processes?
 
Elsmar Forum Sponsor
D

ddunn

#3
Within SCRUM there are 2 types of technical changes, in scope (refinement to existing requirements) or out-of scope (new requirements). The in scope changes are handled through the SCRUM (user story updates) the out of scope changes must go through a CCB process, be approved and normally result in a contract modification. The challenge is to know the difference. This take clear understand and communication of your backlog items.

In SCRUM you can quickly become buried in scope creep if you don't recognize the difference between requirements refinement and new requirements.

Hope this helps.
 
C

christyK

#4
Thanks. That makes sense. I am also considering using the CCB for new processes and tools as well as changes. Do most people include these as well or is it strictly product?
 
Thread starter Similar threads Forum Replies Date
G Change Control for Test Samples Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Z Change color or shape of individual data point in control chart Using Minitab Software 6
N Change Control for processes & products Manufacturing and Related Processes 7
Quality Specialist Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 7
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
D Engineering Change order vs. Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
U Change Management vs Change Control? Design and Development of Products and Processes 4
R Software change control process and defect tracking ISO 13485:2016 - Medical Device Quality Management Systems 1
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
Y Informational Change control process - Major vs Minor change - Active class III medical devices ISO 13485:2016 - Medical Device Quality Management Systems 13
T Change control and configuration management - When to create a new model/part number? Other Medical Device and Orthopedic Related Topics 0
JoshuaFroud Change Control - Minimum Requirements and Unhappy Staff ISO 13485:2016 - Medical Device Quality Management Systems 16
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
A Can change control can be closed if the CAPA is still open? Nonconformance and Corrective Action 3
S DHF File Change Control Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Medical Device Website Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
Y Change Control - General Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
B IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change) IATF 16949 - Automotive Quality Systems Standard 25
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Challenges in document control, revisional control, and change control Document Control Systems, Procedures, Forms and Templates 8
E Control Plan Contents - Part Number / Latest Change Level FMEA and Control Plans 2
M Document Change Control for a Very Small Business Document Control Systems, Procedures, Forms and Templates 12
S How to connect NCMR, Deviations and Change Control ? Nonconformance and Corrective Action 2
V Can Regulatory Head Initiate/Trigger the Change Control for Quality Procedures US Food and Drug Administration (FDA) 9
T Change Control Requirements when changing Suppliers IATF 16949 - Automotive Quality Systems Standard 4
drgnrider How to control documents that most likely won't change ever ? Document Control Systems, Procedures, Forms and Templates 5
T Paper Quality Manual Change Control Methods Quality Management System (QMS) Manuals 5
A Company Name Change & Control of Documents Document Control Systems, Procedures, Forms and Templates 9
L Use of checksum(s) to control product change(s) Misc. Quality Assurance and Business Systems Related Topics 1
C Change Control Forms Post Software Validation Medical Information Technology, Medical Software and Health Informatics 2
T Searching for books which have content of 7.1.4. Change Control topics Book, Video, Blog and Web Site Reviews and Recommendations 2
J Change in our SharePoint Document Control Process - Is this ok? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Is it possible to have a General Change Control SOP and Form? Document Control Systems, Procedures, Forms and Templates 6
H Blood Banking (CFR 21 PART 606) Change Control Requirements US Food and Drug Administration (FDA) 8
K Change Control for Software System that Controls Aspects of GMP Quality Assurance and Compliance Software Tools and Solutions 5
E Help with ECR/DCR Document Change Control Software Validation Qualification and Validation (including 21 CFR Part 11) 6
J ECO (Engineering Change Order) Control for Unreleased Products Document Control Systems, Procedures, Forms and Templates 3
A Change Ratio [Guideline in Control Limit Update] Statistical Analysis Tools, Techniques and SPC 3
L Engineering Change Control Software Systems - Recommendations? Document Control Systems, Procedures, Forms and Templates 2
T TS 16949 compliant Change Control Management Process IATF 16949 - Automotive Quality Systems Standard 3
A Document Control Procedure Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Internal Auditing of Area with Active Change Control Internal Auditing 14

Similar threads

Top Bottom