Potential risks with the current state (until changes are implemented) and any risks that might be temporarily introduced during the change process are adequately assessed.
Interim controls (short-term measures), as needed, are identified and implemented in a timely manner to monitor/mitigate risks associated with the current situation (until change implementation).
This section also recognizes that changes introduce an interim set of conditions that lead to implementation – from opening a machine through massive construction activities, and just about anything else.
A good change control does not just address what is necessary to implement the desired future state. It also contains interim controls for managing the current state until the future is implemented, and addresses all of the potential risks during the process of implementation.
Often the change control stems from an action plan in a CAPA record, where the interim controls are specifically called out and detailed. These may be adequate for a relatively brief period but are not realistically sustainable. Remember that these interim controls must also go through the appropriate change control process. Which may have been a separate change control or be part of this change control. In all cases, the change control should either determine that the CAPA plan is adequate or identify additional risks that were identified during change planning.
Risk assessments for change control should really have three basic risk questions:
What are the risks of the current state as we implement the change?
What are the risks of the implementation process?
What are the risks of the future state?
As discussed elsewhere, these questions are really branching trees.
Every record processed will be reviewed for the event error before completion. Revised preventive maintenance procedure to require vibration test at next preventive maintenance. Increase cleaning frequency of incubator.
Add emergency response steps to address a valve that is malfunctioning. Add engineering check for pump prior to each use. Perform cleaning log review prior to use.
As temporary changes, it is important to determine how they will be implemented, if they require monitoring, and how they will go away. Often the process of implementation of the change removes the temporary changes, but that is not always the case.
With June almost over a look at the five top views for 2019. Not all of these were written in 2019, but I find it interesting what folks keep ending up at my blog to read.
FDA signals – no such thing as a planned deviation: Since I wrote this has been a constant source of hits, mostly driven by search engines. I always feel like I should do a follow-up, but not sure what to say beyond – don’t do planned deviations, temporary changes belong in the change control system.
Effective Change Management: Change management and change control are part of my core skill set and I’m gratified that this post gets a lot of hits. I wonder if I should build it into some sort of expanded master class, but I keep feeling I already have.
Thinking back to my SWOT, and the ACORN test I did at the end of 2018, I feel fairly good about the first six months. I certainly wish I found time to blog more often, but that seems doable. And like most bloggers, I still am looking for ways to increase engagement with my posts and to spark conversations.
The subject of planned deviations made for a raucous “Breakfast with the FDA” session Sept. 25 at the Parenteral Drug Association/FDA conference in Washington.
These are the deviations from standard operating procedures that workers carry out on purpose, typically to keep a pharmaceutical plant operating when for one reason or another they won’t be doing it the way the company said they would.
I wish I had gone to the PDA/FDA conference this year, if for nothing else to have been able to stand up and cheer wildly when this was said:
Brooke Higgins, a senior policy advisor in the FDA drug center’s Office of Compliance, agreed that “it’s a very strange term, and it kind of makes your skin crawl a little bit.”
There is a whole lot more good stuff over at the Pink Sheet’s summary.
I am a firm believer that there are no such things as planned changes. There are change controls, some of which are temporary, occasionally even ones that are retroactive (deviation identifies a change which is formalized in a change control). But all are through the same system, with the same evaluations and assessments and the same sorts of actions.
Keep all changes together. Its a true best practice.