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DMAIC principles associated with Six Sigma methodol- class of the cleanroom or environment?
ogy: Define, Measure, Analyze, Improve, Control. • Is the cleanroom or environment required to be
aseptic?
METHOD DETAIL • What surfaces does the wiper contact in cleaning:
When performing a Cleanroom Wiper Usage Audit, equipment only, walls and floors, general work
the following basic steps will be utilized: surfaces, in-process product, finished product?
• What are the characteristics of the surface contacted:
Step 1: The Definition Phase rough, smooth, heavily soiled?
During this phase of the audit, the primary goal will • What critical parameters are measured on the
be determined and stated, for example: process, in-process product, and the finished
The goal of the Cleanroom Wiper Usage Audit is to product?
produce a significant reduction in manufacturing • Are their any special characteristics required in
costs associated with cleanroom wiper usage with- the process?
out sacrificing process performance and product • What chemicals are used in the process?
quality. • What type of wipers are being utilized: polyester,
non-woven, woven, dry, pre-wetted, sterile?
Step 2: The Measurement Phase
During this phase of the audit, the type of manufactur- Step 3: The Analysis Phase
ing environment, the type of processing technique, During this phase of the audit, more specific require-
the cleaning methods used, and the type of wipers ments of the wiper material will be analyzed along
used will be determined. Typical questions during this with specific wiping methods and wiper usage quanti-
phase are: ties. Typical questions during this phase are:
• Is the processing performed in a cleanroom or a • What are the current wiper specifications and
critical environment area? If so, what is the ISO how are they tested? ➤

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