Unexpected, Proposed and Planned Changes: Change Variation in Life Science Environments
Marci L. Crane
March 28, 2008
Regulated change control (i.e. change control enforced by the FDA, ISO, etc.) may appear to be the control of only one type of change. In other words many professionals may mistake change control to be the control of unexpected changes as life science research and manufacturing processes progress and move forward. This idea however, though essentially true, is only a partial "chunk" of the change types with which a change control system should be equipped to manage. Unexpected changes, as deviations or nonconformances, should undoubtedly be documented, controlled and analyzed but two other types of change should be considered as well in a large array of highly regulated environments.
Proposed Changes
Depending on the industry in question, proposed changes may be those changes suggested by management, the quality department, manufacturing, etc. Other companies may allow all employees to propose changes or in other words file change control requests. Regardless of the type of proposed changes that are filed many regulated companies must adhere to specific processes in order to manage them.
Medical device companies for instance must test and approve proposed changes before change can be implemented and when changes are implemented their status records and process results must be tracked and analyzed closely. For medical device companies these requirements apply equally to investigational devices.
Proposed Changes in Various Areas of Compliance
The control of proposed changes is not only necessary in manufacturing environments but is also a factor during GLP regulated studies and clinical research trials. Companies are right in assuming however that stakes are still high in manufacturing departments. In fact, a recent FDA article Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers states that "Manufacturers have to control changes in all of the major areas in which they operate or function, including processes, product formulation and design, raw materials, equipment, facilities, utilities, computer systems, batch records, SOPs, analytical test methods, work instructions, master device records, specifications and policies."
What departments will take responsibility for proposed changes?
Depending on the company, a variety of departments may be involved in the management of proposed changes. R&D will be especially involved in the review and approval of proposed changes within the manufacturing environment and other R&D professionals may also play a part in managing proposed changes to non-clinical laboratory studies or clinical research studies.
Planned Changes
When careful planning of future studies or manufacturing processes occur, there are often a small myriad of planned changes that can be predicted. These changes may result from the proposed changes already mentioned in this article. These will be the proposed changes that have already been tested, accepted and are planned for action. These changes may seem like they are essentially "wrapped up" but in all reality they are changes that require the coverage of additional (and carefully designed) tasks documented within the company´s change control SOPs and procedures. For example, the article Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers also states the following:
"It is common sense that change control covers planned changes. The company must review and approve them before and after they´re made, and all proposed changes should be tested and approved before they are implemented in manufacturing — even one-time changes. Moreover, manufacturers must have an approved rework procedure in place before they can reprocess product for clinical trials or commercial sale."
The rework procedures mentioned in the FDA article are an essential companion to planned changes as they provide a pillow to any unexpected mishaps.
Contractors and Planned/Implemented Changes
Changes that have been undertaken by contractors to a medical device manufacturer for example must be reported to a representative(s) of the manufacturing company. The procedures acted upon to report these changes must of course be documented by the manufacturing entity that initially hired the contractor organization.
Conclusion
It may be helpful for life science companies to think of change control as the management of unexpected change across company departments and across various levels of compliance but instead as three types of change that must be continually managed within the same dimensions.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to change control technology, please feel free to contact a MasterControl representative.
Proposed Changes
Depending on the industry in question, proposed changes may be those changes suggested by management, the quality department, manufacturing, etc. Other companies may allow all employees to propose changes or in other words file change control requests. Regardless of the type of proposed changes that are filed many regulated companies must adhere to specific processes in order to manage them.
Medical device companies for instance must test and approve proposed changes before change can be implemented and when changes are implemented their status records and process results must be tracked and analyzed closely. For medical device companies these requirements apply equally to investigational devices.
Proposed Changes in Various Areas of Compliance
The control of proposed changes is not only necessary in manufacturing environments but is also a factor during GLP regulated studies and clinical research trials. Companies are right in assuming however that stakes are still high in manufacturing departments. In fact, a recent FDA article Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers states that "Manufacturers have to control changes in all of the major areas in which they operate or function, including processes, product formulation and design, raw materials, equipment, facilities, utilities, computer systems, batch records, SOPs, analytical test methods, work instructions, master device records, specifications and policies."
What departments will take responsibility for proposed changes?
Depending on the company, a variety of departments may be involved in the management of proposed changes. R&D will be especially involved in the review and approval of proposed changes within the manufacturing environment and other R&D professionals may also play a part in managing proposed changes to non-clinical laboratory studies or clinical research studies.
Planned Changes
When careful planning of future studies or manufacturing processes occur, there are often a small myriad of planned changes that can be predicted. These changes may result from the proposed changes already mentioned in this article. These will be the proposed changes that have already been tested, accepted and are planned for action. These changes may seem like they are essentially "wrapped up" but in all reality they are changes that require the coverage of additional (and carefully designed) tasks documented within the company´s change control SOPs and procedures. For example, the article Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers also states the following:
"It is common sense that change control covers planned changes. The company must review and approve them before and after they´re made, and all proposed changes should be tested and approved before they are implemented in manufacturing — even one-time changes. Moreover, manufacturers must have an approved rework procedure in place before they can reprocess product for clinical trials or commercial sale."
The rework procedures mentioned in the FDA article are an essential companion to planned changes as they provide a pillow to any unexpected mishaps.
Contractors and Planned/Implemented Changes
Changes that have been undertaken by contractors to a medical device manufacturer for example must be reported to a representative(s) of the manufacturing company. The procedures acted upon to report these changes must of course be documented by the manufacturing entity that initially hired the contractor organization.
Conclusion
It may be helpful for life science companies to think of change control as the management of unexpected change across company departments and across various levels of compliance but instead as three types of change that must be continually managed within the same dimensions.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to change control technology, please feel free to contact a MasterControl representative.