In the final article of our series, we are going to focus on the role of the Quality Department in supporting the graceful shut down of operations. Companies may need to temporarily shut down because of business demand downturn, or to address safety and health concerns. Obviously, shutting down isn’t as simple as flipping an “off switch.” A graceful shutdown will allow the company to suspend operations while still maintaining the foundation for future activities.
Causes of Operations Shutdown
There are many reasons manufacturers may take full or limited shutdown action during the current crisis, including:
- A direct response to stay at home orders issued by local government.
- A falloff in demand as restaurants, beauty salons, health clubs and other retail establishments cease their own operations.
- An overextended supply chain that means there is simply not enough material available to run production successfully.
- A pause to implement safety or staffing changes. Many organizations will encounter the need for temporary or intermittent shutdowns in order to enable deep-cleaning or to adjust their staffing levels.
Why the Quality Department Will Need to Change Focus
In each of these scenarios, there is an important contribution that the Quality department makes in managing any shutdown or pause in operations. When most Quality plans are designed, they are built around a model of active on-going production. In fact, a key aspect of a Quality Management System is to establish practices that ensure manufacturing can keep operating at some consistent, predictable pace and be constantly served with suitable materials and other resources.
In the case of a shut down or temporary halt, the focus switches to establishing maintenance and completion conditions that will allow materials to survive the halt undamaged. The Quality department will have to change their focus from supporting constant movement to implementing defined cut-offs. They will need to document new procedures and confirm that designated conditions are met and upheld.
How the Quality Department Supports a Shutdown
For the Quality department, any shutdown (and restart) will have three phases of activity that need to be addressed. These are:
- Qualify the restart
To prepare for shutdown actions, the Quality department will need to identify the controllable breaks in the process flow, as well as understand the volume of resources needed to complete tasking between breaks. The breaks can be as obvious as the timing of when products switch department ownership and are typically pretty intuitive. Understanding the available capacity of labor or machine resources that can be applied to reach a stage of completion is generally more complex and outside of the role of Quality.
In this circumstance Quality will focus on defining the standards for condition of completion and condition of storage around break points. From this information, Operations staff will understand how to prioritize the application of their resources to ensure that these standards are met.
Investigating, defining and documenting these process breaks are the main preparation tasks of Quality when supporting shutdown planning.
Once the shutdown has occurred, focus will switch to the monitoring of materials and materials condition, to ensure that they remain viable and available for restart. Understanding the conditions of storage and creating an appropriate monitoring plan will be part of the role of Quality. The monitoring plan should incorporate timing of reviews and parameters of acceptable conditions such as temperature or moisture. If spaces used for storage are normally used for such activities then there will most likely be defined data specifications that can be incorporated.
A monitoring plan should also take into consideration shelf life constraints for the materials and an evaluation of the impact on shelf life of storage methods. If the target date for restart is unknown, it will be critical to monitor for shelf life so that appropriate adjustments in material use can be made. If possible, it is helpful before a shutdown occurs to understand how changes or use of alternative storage methods will affect shelf life and incorporate that information into your plans.
Contamination risks from outside factors like deep-cleaning should also be considered when developing monitoring plans. The ultimate goal is to keep products stable and suitable for use when operations restart.
Qualify the Restart
Documentation that captures the parameters and policies of restarting will also have to be developed and signed off. Most likely, you will begin developing the restart checklists based on the proceeding manufacturing operations. If you have existing ‘first article’ procedures, they will also serve as inspiration for what should be on your checklists. Calibration activities should be on the list and you should have a plan for ramping up operations over some time frame so you can monitor and verify the operability of equipment. If staff has been absent for a while, or if there are new employees, be aware there will be some loss of familiarity with both tasking and equipment.
Safety should be a priority on your checklist. It is simply human nature to adapt our behaviors in a time of crisis and uncertainty. If there is a possibility that staff might interpret the urgency of restart as a reason for not complying immediately with safety measures, then taking a moment to reinforce safety behaviors will be important.
Finally, when developing your restart processes, give plenty of thought to cleaning and cleaning procedures. Depending on the length or purpose of shutdown, there may be agents in the environment that need to be removed from equipment.
Managing Shutdown Risk
Overall you will want to ensure your business can pass through this period with minimal loss of materials and revenue and come back when it ends, with a solid plan for restarting. Your Quality department is the key to managing your shutdown risk. They will be engaged in ensuring the activities related to a shutdown are documented and set-up for future success.
Your Shutdown Stories
At Quality Essentials Suite we’d like to hear from you about your challenges with managing a successful shutdown and restart. What was the most surprising? What would you do differently? If you’d like to help others by sharing what you learned, let us know. Please comment below or use our Contact Us form to drop us a private note.