Topic Question
Process Definition Is there a written defined process description? (Not required) If not, can the
process be described by process participants?
Are tools such as process FMEA, hazard analysis, mistake-proofing, or other
tools used for identifying risks and planning process activities?
Have inputs into the process been defined? (Data, materials, resources, etc.)
Have expected outputs from the process been defined?
Have procedures, instructions, and forms been established as needed to
control the process?
Are procedures, instructions and forms used in controlling the process readily
available?
Do procedures, instructions and forms accurately reflect the practices?
(Note: Requires auditor review and observation!)
Are customer (internal and external) requirements defined?
Are documents understood by process participants?
Resources How many people participate in the process? Is this adequate to achieve
process requirements?
Are participants clearly aware of their roles, responsibilities and authorities
and those of other participants?
Are participants adequately trained to carry out roles, responsibilities, and
authorities?
Is equipment (manufacturing, measuring & monitoring equipment; transport &
moving equipment; hardware/software; PPE; etc.) adequate for its intended
use?
Is equipment identified to allow participants to determine the readiness of the
equipment for safe and effective use prior to and during operation?
Are 5S or other techniques used effectively for ensuring "a place for
everything and everything in its place"?
Process Execution
Is observed process activity consistent with approved plans and procedures?
Is the process flow constructed to avoid unnecessary movement of materials
and personnel?
Are redundant and non-value adding activities minimized?
Is material usage maximized to avoid waste?
Is waste material effectively removed and segregated from the process?
Are unused materials returned to the correct location in conditions suitable to
allow re-use?
Are process outputs passed on to subsequent processes only when all
planned process activities are completed?
Process Monitoring Are process monitoring activities carried out according to approved plans and
procedures?
Is process monitoring compared against standards to determine the current
status of the process?
Is process status communicated to appropriate members of the process
team?
Are records of process monitoring maintained according to approved
procedures?
Have key performance indicators (KPI) been established to allow the
effectiveness of the process to be evaluated?
Are KPI consistent with quality and business objectives?
Are KPI consistent with customer requirements?
Are KPI reviewed and communicated to the process team, as appropriate, by
process leaders?
Correction & Improvement Have process participants been trained effectively to allow them to identify a
"process upset" condition (ex. Nonconforming product; process out-of-
control)?
Have process participants been trained effectively to allow them to identify
trends toward a process upset?
When a process upset occurs, are approved activities carried out to bring the
process back into a state of control?
Are records of process upsets and actions taken properly maintained?
Are records of process upsets and actions taken reviewed regularly to
determine opportunities for corrective and preventive action?
Are KPI used to identify opportunities for improvement (preventive action)?
Are all process participants encouraged to be involved in identifying
improvements?
Where corrective/preventive actions or other opportunities for improvement
have been implemented, has the action(s) taken been demonstrated as
effective?
Objective Evidence Status
