31Manufacturing (Facility) Site Assessment (MSA)
the appropriate designation is incomplete (INC). INC is appropriate only if one
or more subelements are not ranked red, yellow, or green.
For the subelement expectations, it is important to remember that a G
implies a High Quality of Event/Meets the Expectation and the Intent of the
Expectation Guidelines/Item is Complete. A Y implies a Marginal Quality of
Event/Marginally Meets the Expectation and the Intent of the Expectation
Guidelines/Concurred and timed recovery plan is in place and on sched-
ule. An R implies an Unacceptable Quality of Event/Does not Meet the
Expectation and the Intent of the Expectation Guidelines and there is no plan
or it is inadequate to meet the schedule.
Comments or evidence: All expectations regardless of color rating
must have documented evidence listed including examples and part
number viewed.
Action plan: Action plan, responsibility, and due date are required
entries for all yellow- and red-rated expectations.
Responsibility (Resp.): The person who is responsible for making sure
that the element requirements will be completed.
Due date: The date that the requirements are due to be completed.
Actual date: The date that all requirements for the element are
completed.
Expectation guidelines: Generally, they are given by the customer as
a springboard of ideas. They are not meant to be all-inclusive. It is
very important to mention here that whereas the expectations were
given in a list of 15 categories (see previous list), these guidelines
provide detailed insights as to what exactly the customer is look-
ing for from the supplier. Obviously, they are not exhaustive. Each
customer–supplier relationship should have a good understanding
of what is needed and wanted, and the guidelines should support
that goal. Here we provide a sample of what may be considered a
guideline for each of the 15 categories.
• Planning for manufacturing process capability. Minimum
requirements should include all ISO 9001 and industry-specic
items with a focus on the quality manual, procedures, instruc-
tions, records, internal audits, and corrective actions, as well
as specic metrics for input and output variables, management
responsibility, and so on.
• FMEAs/control plans. Minimum requirements should include
current FMEAs, process ow charts, and control plans. Key inputs
for FMEA should include robustness and appropriate denitions
for critical and signicant characteristics. Emphasis on preven-
tion should be the prevalent approach as opposed to detection
and control. Control plans should include the characteristics that