Scribd
Upload
87 views1 page

QMS Audit Checklist 2 - Basic Production Process

This document provides a checklist to evaluate workstations and activities within a production process. It includes basic questions about procedures, materials identification and inspection, calibration of measurement devices, maintenance, training, statistical process control, and handling of nonconforming products. References are given to related sections in a more detailed Full Production Process Checklist for investigating problem areas identified through this basic audit.

Uploaded by

Florina Gaspar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
87 views1 page

QMS Audit Checklist 2 - Basic Production Process

This document provides a checklist to evaluate workstations and activities within a production process. It includes basic questions about procedures, materials identification and inspection, calibration of measurement devices, maintenance, training, statistical process control, and handling of nonconforming products. References are given to related sections in a more detailed Full Production Process Checklist for investigating problem areas identified through this basic audit.

Uploaded by

Florina Gaspar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 1

Process Audit Checklist 2 – Basic Production Process Checklist Page No.

_________
This checklist should be used to evaluate each workstation/activity within the overall process under review. If
weaknesses or problems are noted, either as a part of this review or as part of the pre-audit planning, then the more
detailed Full Production Process Checklist can be used to more thoroughly investigate the suspect activities.
References to related sections on the Full Production Process Checklist are provided.

Standard Requirements Reviewer Checks

Basic Production Process Audit Questions


Have the operator walk you through/discuss the process Basic Process Information:
being performed. During the discussion, verify the Name of workstation/activity: _______________________________
following items:
1. Is there a procedure/instruction at the Operator(s): _____________________________________________
workstation? Is it current (note the rev. # for later
comparison to the master list). (5)
Procedure/Instructions: _____________________ Rev: __________
2. Is the procedure being followed? Ask the operator
if the procedure is adequate. Note any deficiencies
or inadequacies. (4)
Equipment Avail./Downtime Trend: _________________________
3. Are material and parts properly identified? Can
everything be identified? How? (9)
4. Is the inspection status for materials and parts Gage/Device Type: __________________ Serial #: _____________
identified? Ask the operator how they know their
incoming product is good. (9)
5. Are the inspections required by the Control Plan Control/Insp. Plan # ________________________ Rev:___________
or Inspection Plan being performed? Are they at
the right frequency? The right sample size? The
right measurement device? (11, 12) Overall evaluation:
6. Are the measurement devices used at this
workstation calibrated? Are they being properly
Conforms. No deficiencies identified.
handled and stored when not in use? (14)
Opportunity for improvement. Detail below.
7. Is maintenance adequate? Are PM tasks being
Best Practice. Detail below. Be specific.
accomplished as required? Are the PM’s sufficient?
Are spare parts available? Review equipment Nonconformity. Provide details below. Reference the specific
downtime or availability performance and trends, if requirement violated.
poor review in detail. (13)
8. Are the operator(s) properly trained? Check Full Description of NC/OFI/BP (use back if necessary)
training records later. Are operators aware of the
importance of their actions to the QMS/EMS? Are
they aware of any significant environmental
aspects?
 Competency (7)
 Awareness (7)
9. If SPC is used at this station, is it being properly
conducted? Is it effective? Review the charts for
out-of-control conditions. (11)
11. Is nonconforming product control acceptable?
Do operators understand how to handle it? (10)
12. Other items (list)

You might also like