Barbara Kanegsberg
Edward Kanegsberg
BFK Solutions LLC
Pacific Palisades, Calif.
W
Successful high-performance cleaning processes benefit from following a
well-designed plan.
e all want manufacturing processes that are reliable, that don’t cost an arm and a leg, that meet
or exceed customer or regulatory requirements.
To achieve high-performance cleaning processes,
use the 4Ds—define, develop, document, defend.
Define
Know your target before you select a weapon, aim, or fire.
What is the cleaning process supposed to accomplish? What
specific factors are needed to get there? It is important to
define the overall process as well as the sub-processes that
are used to accomplish the goal. A process flow diagram can
outline what comes before and what will ensue next in the
process, but a flow diagram itself is not enough. It is also
important to know what equipment and/or chemicals are
needed, as well as how much time and labor will be required.
You have to know where cleaning occurs, both in-house
and by your suppliers. That can be easier said than done.
Cleaning processes are not always recognized as being cleaning. Your suppliers may incorrectly assume that you have the
responsibility for cleaning.
Process definition includes the methods and metrics
that determine that the process step has been completed.
For instance, if this is a cleaning process, how will the
cleanliness be measured? Purely visual? Via an analytical
method?
Develop
It takes a village, often a global village, to develop a world-class cleaning process. This includes working collaboratively
and critically with vendors who supply cleaning equipment
and chemicals. Define your plan to find and evaluate these
vendors.1 Develop your supply chain. Is it a good idea to use
an inexpensive supplier who supplies partially cleaned or
inconsistently cleaned parts? Does your supplier pass all the
cleaning on to you? It may help to be reminded that the longer a soil resides on a part, the harder it is to remove.
Developing a process means planning for actual produc-
tion conditions. Processes that are quite acceptable during
R&D may be inadequate for production. How will you man-
age a surge in production? 2 Add shifts? Pull retired equip-
ment out of the warehouse? Outsource?
Consider the safety and environmental aspects of the
cleaning process. Will you need to consider equipment for
containment or personal protection? Consider the certifications you either need or would like to have. Even if a process
is perfectly legal, will it meet resistance by the employees who
perform it (for example, due to unpleasant odors)?
Document
Once a process has been defined and developed, it is necessary to have clear, executable instructions for implementing,
duplicating, and performing the process. Employees need
instructions they can follow. If another employee undertakes
the task, will they be able to get the same result? A scientific
research result will usually not be accepted until others can
duplicate the findings. The same should be true for day-to-day production.
Documenting also includes training. How will the process be taught to employees? Step-by-step recipes have more
value if rationales for process steps are provided. Technicians
can become innovators to make processes better when they
understand why a step is being done, rather than being simply ordered to follow directions.
Documentation also means adequate monitoring. This
includes monitoring process conditions such as temperatures and the status of a cleaning bath. Periodically audit
the cleaning process, whether it is in-house or outsourced.
This includes auditing the cleaning processes of your supply
chain.
Processes can and most likely will evolve. Sometimes
this is because someone comes up with a better mousetrap,
an improved or more cost effective way of performing the
process. Maybe the process step really isn’t needed and its
functions can be accomplished somewhere else in the overall
process. Or perhaps the process is not accomplishing its aims
and needs to be made more robust. At times, change is dictated from outside, by a customer requirement or by a new
regulatory restriction. When the inevitable change occurs,
have a procedure for evaluating proposed changes and
amending the process instructions. If questions should arise
due to product performance, it can be invaluable to be able
