Engineering Change Control (ECC) is a critical process in any engineering project, ensuring that modifications to designs, specifications, or processes are managed systematically and effectively. It’s a vital tool for maintaining product quality, safety, and compliance. However, initiating an ECC can be a complex and multifaceted process, requiring careful consideration and planning.
This post seeks to offer a thorough how-to for implementing Engineering Change Controls, utilizing a series of stimulating questions to assist you in navigating the procedure.
1. Type of engineering Change
a. Facility
b. Utility
c. Equipment Manufacturing Related
d. Equipment Laboratory Related
2. Does the description specifies:
a. Is the equipment / utility / facility new or renovated?
b. Location
c. Is the Equipment Software driven?
d. List equipments that work in conjunction with this equipment
e. List utilities used by the equipment
f. Is the engineering Change been performed in a controlled or validated area / system?
g. Are additional materials needed to implement the change?
3. Has the request been evaluated for penicillin contamination?
4. Has the request been evaluated by the Regulatory team?
5. Has the request been evaluated by the EHS Department?
6. Has the request been evaluated to establish Validation Recommendations by technical area?
7. Does this Change require an update to Laboratory electronic systems?
8. Master Batch Record revision needed?
a. Specify Master Batch Record Stages impacted
b. Specify product codes and presentations
9. Provide the number of the Lots affected?
10. Is this Change Classified as a Physical Change?
a. Are drawings impacted by the Change?
11. What type of drawing is impacted?
a. Facility
b. Utility
c. Equipment
d. Others
12. List the Procedures affected by the change?
13. Is there impact on Specification Tests and Methods?
14. Stability Recommendations?
a. Stability requirements?
15. Requires a Factory Acceptance Test (FAT)?
16. Requires Commissioning/ Decomissioning?
17. Aseptic Process Simulation Required?
After reading this blog, we hope you can understand the importance of change control and properly use the proposed checklist and improve on it further.
Now that you know this:- hopefully you are in position to answer the Assignment(s)
Have you been involved in any change control activities in your lab? If yes recollect your activities?
Does your lab have proper SOP for the implementation of change control in your lab? If so are there effective?
Do you clearly identify whether proposed changed is Critical/Major/Minor? If yes what is the criteria?
Do you clearly identify whether proposed changes effect the quality of the product? Stability of the product? If so then it is properly captured and its impact properly assessed?
What is average time period required to properly close change control in your lab? Can you suggest any 3 measures to improve the quality of change control?
Have you found any communication gaps between different departments to smoothly close change control system?