Docstoc

PROCESS AUDIT CHECKLIST - DOC

Document Sample
PROCESS AUDIT CHECKLIST - DOC Powered By Docstoc
					             INTERNAL AUDIT CHECKLIST: PRODUCTION MGMT.
                                              See Key Process Map, KP004
Dept(s):                                                     Date:

Auditor(s):                                                  Auditee(s):

Applicable Work Instructions:                                      WIPAI01-11, Paint WIs, Rev:
   WS001, Workmanship Standards, Rev:                             WIPRD01-29, 32-37 Production WIs, Rev:
   WIGEN01, Nonconformance Reporting, Rev:                        WIPRG01, Electronic Drawings, Rev:
   WIGEN02, Product Alert, Rev:                                   WIPRG04, Changing Prd. Docs & Data, Rev:
   WIMAT05, Hardware Kitting, Rev:                                WIPRG05, Release of Jobs to Production, Rev:
   WIMAT06, Machine Setup, Rev:                                   WIQUA01-2,4,6,9,13-15 Quality WIs
   WIMAT10, Ink Stamp, Rev:                                       WISIL01-8, Silkscreen WIs, Rev:
Questions                                                    Yes       No      Comments
PROCESS DEFINITION & IMPLEMENTATION
Is the process clearly identified? (4.1)
Are responsibilities and authorities clearly identified
for the process? (5.5.1)
Are adequate resources and infrastructure provided
for the process? (6.1, 6.3)
Is there evidence that the process is being carried
out as planned? (4.1)
AWARENESS & COMPETENCE
Are personnel aware of the policy statement and its
meaning to their job? (5.3)
Are competency requirements defined for the
process? (6.2.2)
Are personnel performing activities in the process
competent (i.e., are there records of training,
experience, skills or education)? (6.2.2)
Are personnel aware of the relevance and
importance of their activities and how they
contribute to the achievement of the objectives?
(6.2.2)
PROCESS DOCUMENTATION & RECORDS
Are there documents available to ensure the
effective planning, operation and control of the
process? (4.2.1d)
Are documents related to this process under proper
document control? (4.2.3)
Are documents available for this process in areas
where they are needed? (4.2.3d)
Are records maintained for this process? (4.2.4)
Are records adequately controlled? (4.2.4)
PROCESS ANALYSIS & IMPROVEMENT
Are criteria identified for ensuring the effective
operation and control of the process? (4.1c)
Are actions taken to ensure that planned results are
achieved? (i.e. inspection, review) (4.1f)
Are suitable methods used to monitor and measure
the process? (8.2.3)
Are actions taken to cause continual improvement
of the process? (4.1f, 8.5.1)
FMQUA51A: Internal Audit Checklist: Production Mgmt.      8/14/08                                         Page 1 of 5
             INTERNAL AUDIT CHECKLIST: PRODUCTION MGMT.
Questions                                                   Yes   No   Comments
PROCESS-SPECIFIC REQUIREMENTS
Planning & Control
Has the organization planned and developed the
processes needed for product realization? (7.1)
Does the organization determine
a) quality objectives and requirements for the
    product?
b) the need to establish processes, documents, and
    provide resources specific to the product?
c) required verification, validation, monitoring,
    inspection and test activities specific to the
    product and the criteria for product acceptance?
d) records needed to provide evidence that the
    realization processes and resulting product meet
    requirements?
e) resources to support operation and maintenance
    of the product? (7.1)
Is the output of this planning in a form suitable for the
organization’s method of operations? (7.1)
Production Control
Is suitable equipment available? (7.5.1)
Are adequate devices/equipment available for
monitoring and measurement? (7.5.1)
Is there accountability for product during
manufacture?
Evidence that all manufacturing and inspection
operations completed?
Provision for prevention, detection and removal of
foreign objects?
Monitoring of utilities and supplies (water,
compressed air etc) for product quality?
Criteria for workmanship stipulated clearly? (7.5.1)
Is approved data used for production operations, and
in what form? (drawings, parts lists etc) (7.5.1.1)
Are production process changes controlled, and
who is authorized to approve? (7.5.1.2)
Are production equipment and tools controlled and
validated prior to production? (7.5.1.3)
Is work ever transferred outside the organization’s
facilities, and with what controls? (7.5.1.4)
Is servicing of a product ever requested? If so, how
is it controlled? (7.5.1.5)




FMQUA51A: Internal Audit Checklist: Production Mgmt.   8/14/08                    Page 2 of 5
             INTERNAL AUDIT CHECKLIST: PRODUCTION MGMT.
Questions                                                  Yes    No   Comments
Special Processes
Are processes that cannot be verified by
subsequent inspection and test validated? (7.5.2)
Does validation of special processes demonstrate
the ability of these processes to achieve planned
results? (7.5.2)
Has the organization established arrangements for
these processes including, as applicable:
a) defined criteria for review & approval of the
   processes?
b) approval of equipment & qualification of
   personnel?
c) use of specific methods and procedures?
d) requirements for records?
e) revalidation? (7.5.2)
Configuration Control
Does the organization suitably identify the product
and its configuration throughout product realization?
(7.5.3)
Is the inspection and test status identified? (7.5.3)
How are acceptance authority media such as
stamps, electronic signatures controlled?
When traceability is a requirement (e.g. date code,
serial #), is this identification controlled and
recorded? (7.5.3)
Does configuration control
     a) identification throughout product life?
     b) products by raw material batches?
     c) identity of components by assembly?
     d) sequential record of production?
Customer Property
Is customer property identified, verified, protected
and safeguarded while under the company’s
control? (7.5.4)
If customer property is lost, damaged or otherwise
found to be unsuitable, is it reported to the
customer and are records maintained? (7.5.4)




FMQUA51A: Internal Audit Checklist: Production Mgmt.    8/14/08                   Page 3 of 5
             INTERNAL AUDIT CHECKLIST: PRODUCTION MGMT.
Questions                                                 Yes    No   Comments
Product Preservation
Is the conformity of product preserved during
production, through the use of handling, packaging,
storage and protection methods? (7.5.5)
Does preservation extend to the constituent parts of
a product including
     a) cleaning
     b) prevention, detection and removal of foreign
        objects
     c) special handling for sensitive products
     d) safety warnings
     e) shelf life control and stock rotation
     f) special handling for hazardous materials
        (7.5.5)
Is documentation required to accompany product
present at delivery and in good condition? (7.5.5)
Inspection & Test
Are product characteristics suitably monitored and
measured at appropriate stages of production to
verify that product requirements are met (e.g., by
inspection and testing)? (8.2.4)
Is evidence of conformance to requirements kept,
with acceptance criteria? (8.2.4)
Do acceptance records indicate the person
authorizing release of the product? (8.2.4)
Is product held until all planned arrangements (e.g.
traveler requirements), including inspection and test
requirements, have been met, unless approved by
a relevant authority and/or the customer? (8.2.4)
Nonconforming Product
Does the organization ensure that product which
does not conform to product requirements is
identified and controlled to prevent its unintended
use or delivery? (8.3)
Are the controls and related responsibilities and
authorities for dealing with nonconforming product
defined in a documented procedure? (8.3)
Does the organization deal with nonconforming
product by one or more of the following ways:
a) by taking action to eliminate the detected
   nonconformity?
b) by authorizing its use, release or acceptance
   under concession by a relevant authority and,
   where applicable, by the customer?
c) by taking action to preclude its original intended
   use or application?
d) Is scrap product conspicuously and permanently
   marked, or otherwise rendered unusable? (8.3)

FMQUA51A: Internal Audit Checklist: Production Mgmt.   8/14/08                   Page 4 of 5
             INTERNAL AUDIT CHECKLIST: PRODUCTION MGMT.
Questions                                                 Yes    No   Comments
Are records of the nature of nonconformities and
any subsequent actions taken, including
concessions obtained, maintained? (8.3)
When nonconforming product is corrected is it
subject to re-verification to demonstrate conformity
to the requirements? (8.3)
When nonconforming product is detected after
delivery or use has started, does the organization
take action appropriate to the effects, or potential
effects, of the nonconformity? (8.3)
                                    NOTES/ADDITIONAL QUESTIONS
 Additional sheets attached




FMQUA51A: Internal Audit Checklist: Production Mgmt.   8/14/08                   Page 5 of 5

				
DOCUMENT INFO
Shared By:
Categories:
Stats:
views:776
posted:3/6/2011
language:English
pages:5