ADVANCE ENGINEERING INTERNAL AUDIT CHECKLIST for ISO 9001:2000 Date of Audit: Auditor Name:
MANAGEMENT ORIENTED PROCESSES (M.O.P.)CHECKLIST C/A=Corrective Action QMS=Quality management system
Objective Evidence Compliant
ISO 9001:2000 ISO Clause Procedure Requirement What to look for Who to go to Auditor notes Who Shift Y
Business 5.4.1 AEP 5.4.1.1 Review of progress toward the Ask to see evidence of business plans, Plant Mgr +
Planning - achievement of buiness plan corporate, plant wide and departmental. Engineering
objectives, both corporate and Look at the objectives to see if there is
departmental. progress being tracked toward their
Objective: Corporate achievement. If there is negative progress
has a plan for running
the business, the or is behind schedule there must be action
Plant mgr. has plans to getting back on track.
monthly meetings in
which progress is
reported, then
updated objectives
(i.e. goals) are given
and reported back AEP 5.4.1.1 states that there is a one Review to confirm that these plans are Plant Mgr +
onto departmental year and a three year business plan. getting updated and do not exceed the one Engineering
plans and progress is and three year limits.
tracked and reported
to feed the corporate
plan.
AEP 5.4.1.1 states that relevant Have them describe how the updated Plant Mgr +
portions of the revised corporate plan corporate business plan objectives and Engineering
are communicated throughout the goals are communicated and applied to
entire corporation and passed on to new departmental objectives.
plant departments.
Ensure that revision of procedure is up to Plant Mgr +
date and any other relevent Engineering
documentation. How long are these
records retained for?
On charts and graphs, are there goal lines Plant Mgr +
added to easily see what the expectation Engineering
is and whether they are meeting it.
If they are not
meeting the targets, is there C/A and/or an
action plan describing what is needed,
who is responsible and target dates?
Management 5.6.1 + 8.5.1 AEP 5.6.1 Does top management review the Review records of these minutes in the Plant Mgr +
review - Objective: QMS at planned intervals to ensure its key measurables book. Form AEP01-1A Engineering
this is all about suitability and effectiveness. should be used to document attendance,
making sure that Top
mgt (i.e. Plant, date of meeting and summarize what the
Quality, HR mgr's) is agenda was.
looking at certain
measured items that
indicate the health of
the organization and
how pleased
customers are, then to This review will include quality policy How often is the Quality Policy reviewed to Plant Mgr +
set plans to achieve and objectives. ensure that objectives are still relevant. Engineering
set goals. (e.g if a past objectives targets were met,
then it should no longer be listed and the
policy updated)
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 1 of 14
ADVANCE ENGINEERING INTERNAL AUDIT CHECKLIST for ISO 9001:2000 Date of Audit: Auditor Name:
MANAGEMENT ORIENTED PROCESSES (M.O.P.)CHECKLIST C/A=Corrective Action QMS=Quality management system
Objective Evidence Compliant
ISO 9001:2000 ISO Clause Procedure Requirement What to look for Who to go to Auditor notes Who Shift Y
This review will include opportunities Ask when and how changes such as Plant Mgr +
for improvement and changes to the personnel and equipment is discussed. Engineering
QMS.
Management 5.6.2 Review AEP 5.6.1 As part of management review, AEP Records of audit program summeries in Plant Mgr +
review input 5.6.1 indicates that input to the the "Key Measurables" book that Engineering
management review meeting includes; management reviews results of audits.
1. results of audits
2. customer feedback Evidence that management reviews Plant Mgr +
feedback from customers. Engineering
3. process performance and product Evidence that management reviews Plant Mgr +
conformity PPM's, Cpk's, downtime, scrap, ect. Engineering
4. status of preventive actions preventive actions are those in which the Plant Mgr +
company has looked at how to prevent an Engineering
issue form ever happening in the first
place. (e.g. FMEA, SPC where a trend is
curbed before it goes out of spec, audit
results, advance planning/APQP)
5. status of corrective actions Evidence that management reviewed the Plant Mgr +
8D's. Engineering
6. follow-up from previous reviews look at action items assigned from the Plant Mgr +
meeting prior to the last to ensure that Engineering
action items were followed up on.
Delivery performance Evidence that management reviewed Plant Mgr +
delivery performance, look for evidence Engineering
evaluation of occurance or of C/A for late
shipments.
5.6.3 Review improvements to QMS or product Examles of continual improvement in Plant Mgr +
output - needs, and resource needs these areas stemming from management Engineering
remember that reviews. An auditor should be able to see
continual progress tracked of objectives as one
improvement indication of continual improvement, then
is an output of follow-up with interview question of what
management else are improvements.
reviews.
Internal audit 8.2.2 + 8.2.3 AEP 8.2.2 Ask who has the responsibility at the plant Plant Mgr +
There must be oversight by someone level for the entire oversight. Engineering
assigned to the entire system
including but not limited to; Does this jive with the procedure
scheduling, training, review of AEP 8.2.2?
findings, follow-up to ensure closure of
NCR's.
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 2 of 14
ADVANCE ENGINEERING INTERNAL AUDIT CHECKLIST for ISO 9001:2000 Date of Audit: Auditor Name:
MANAGEMENT ORIENTED PROCESSES (M.O.P.)CHECKLIST C/A=Corrective Action QMS=Quality management system
Objective Evidence Compliant
ISO 9001:2000 ISO Clause Procedure Requirement What to look for Who to go to Auditor notes Who Shift Y
AEP 8.2.2, completed audit cover sheets, Audit
completed checklists, audit schedule. program
Must have a procedure that spells out manager
the responsibility and requirements for
planning (a schedule) and conducting
audits, and for reporting results and
maintaining records.
Internal audit 8.2.2 + 8.2.3 + AEP 8.2.2 Internal audits must be scheduled. Request schedule Audit
8.5.3 program
manager
review that schedule is followed look for
yourself
Review audit results Review audit results to ensure that look for
auditors do not audit their own work. yourself
Management responsible for the area Ask for 8D's issued from audit findings. Audit
being audited shall ensure that actions Look to see that it was effectively closed program
are taken without undue delay to out in a timely fashion and that it was manager
eliminate nonconformities and their noted as verified.
causes. Follow-up activites will be
done to enure effectiveness and
closure.
Selection of auditors and conduct of Ask how auditors are selected, what is the Audit
audits will ensure objectivity and criteria. Ensure that each auditor has an program
impartiality of the audit processs. AEP17-1A training form completed for manager
them.
Customer 8.2.1 AEP 8.2.1 Monitor information relating to AEC uses performance indicators of Plant Mgr +
Satisfaction customer perception whether AEC has Quality (PPM), on-time delivery, customer Engineering
met customer reuiqrements. concerns (concern log and 8D's) and + Quality
monitors the manufacturing processes to
demonstrate conformance to product
quality (SPC) and efficiency of the
process.
Ensure that yearly customer Should be a systematic approach where a Sales,
satisfaction survey is done. list is generated showing what, when and customer
to whom the survey was sent and those service
that return as well as follow-up to those
* note: this is a yearly survey so whom haven't responded in order to get
there should be a thought out plan of that information.
when, how and who will send,track
and analyze the data.
Use of from AEP01-2A Sales,
customer
service
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 3 of 14
ADVANCE ENGINEERING INTERNAL AUDIT CHECKLIST for ISO 9001:2000 Date of Audit: Auditor Name:
MANAGEMENT ORIENTED PROCESSES (M.O.P.)CHECKLIST C/A=Corrective Action QMS=Quality management system
Objective Evidence Compliant
ISO 9001:2000 ISO Clause Procedure Requirement What to look for Who to go to Auditor notes Who Shift Y
Surveys received back is analyzed Sales,
statistically and reviewed by management. customer
Comments are reviewed and acted upon service
as required.
Customer 8.2.1 AEP 8.2.1 If data indicates that an area of
Satisfaction satisfaction, or an individual customers
expectations are not being met, then the
auditor should look for evidence of action
plans and progress tracking to improve
that area.
Determine the methods for obtaining Usually done during the quoting phase of Sales,
and using information related to the bidding. They should be capturing things customer
understanding of what exactly the such as why did the customers change service
customer requirements are that will suppliers and what the product is used for,
lead to customers perception of their etc. Use of a form titled "Customer Quote
satisfaction, not what AEC believes it Information".
to be.
Corrective 8.5.2 AEP 8.5.2 Documented procedure to define AEP 8.5.2 and the 8D database, review Quality
Action requirements for (a)review this for completeness and that system is
nonconformities, including customer managed well.
complaints,
(b) determine the causes, review some 8D's and look at section 2 Quality
(investigation) and section 5 (root cause)
c) evaluating the need for action to review some 8D's and look at section 6 Quality
ensure it does not recur, (permanent corrcetive action)
(d) determining and implementing review some 8D's and look at section 7 Quality
action needed, (actions to prevent recurrence)
(e) records of results, completed 8D's with signatures of Quality
approval and applicable data and attached
supporting documents. These are in the
8D book in Quality.
(f) review of corrective action taken ensure follow-up and verification of its Quality
effectiveness on section 8 of 8D's.
Preventive 8.5.3 AEP 8.5.3 Review procedure AEP 8.5.3 Quality
action
Remember that these are things that Ask to see how scrap is tracked and Quality
have not occurred yet, this is reviewed. Are the causes identified and
prevention not correction. tracked over long term and are there
programs in place to stop these, these are
things that could get to the customer.
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 4 of 14
ADVANCE ENGINEERING INTERNAL AUDIT CHECKLIST for ISO 9001:2000 Date of Audit: Auditor Name:
MANAGEMENT ORIENTED PROCESSES (M.O.P.)CHECKLIST C/A=Corrective Action QMS=Quality management system
Objective Evidence Compliant
ISO 9001:2000 ISO Clause Procedure Requirement What to look for Who to go to Auditor notes Who Shift Y
Ask to look at SPC, if used properly trends Quality
in data will be monitored and correction
made based on these trends to prevent
products from ever becoming NG.
Preventive 8.5.3 AEP 8.5.3 Remember that these are things that Look at whether customer concerns are Quality
action have not occurred yet, this is part of 8D's, e.g. if a customer has a
prevention not correction. concern but has not required an 8D, but
AEC does one internally to prevent issue
from ballooning.
Is advanced planning on-going for 1. Who is in charge of leading new and Engineering
new products and processes, this changed projects (a.k.a. project manager) + Quality
advanced thinking will reduced 2. What tool
likelihood of problems occurring after do they use to contiuously track items and
the fact. Best practice is to have a the progress made.
project manager who uses gantt
charts, basically a laundry list of what 3. Can they
has to happen and when, plus who is show the auditor what are all of the current
assigned in order to accomplish the projects being bid on, bids won and their
goal, and tracks progress. drop dead dates for having conforming
product to the customer?
4. If some other meatod is used, does it
live up to the expectations of disciplined
planning?
Look at whether FMEA methodology is Engineering
used. This is a form used to identify + Quality
problems before they occur and rate them
to determine if they pose enough risk to
implement a control to prevent their
occurance. (refer to AIAG reference
manual FMEA)
Continual 8.5.1 none AEC will continually improve the Ask for examples of improvements in any Plant Mgr +
Improvement effectiveness of the QMS through use and all processes including; supplier Engineering
of Quality Policy, objectives (key development, any improvements, + Quality
measurables), audit results, through housekeeping (I.e. lighting), etc.
analysis of data, corrective &
preventive actions and as an output of
management review.
Look to see if progress is being tracked Plant Mgr +
from key measurables, if there is progress Engineering
it is construed as continual improvement. + Quality
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 5 of 14
ADVANCE ENGINEERING INTERNAL AUDIT CHECKLIST for ISO 9001:2000 Date of Audit: Auditor Name:
MANAGEMENT ORIENTED PROCESSES (M.O.P.)CHECKLIST C/A=Corrective Action QMS=Quality management system
Objective Evidence Compliant
ISO 9001:2000 ISO Clause Procedure Requirement What to look for Who to go to Auditor notes Who Shift Y
Analysis of 8.4 none Does AEC at least monitor and There should be some chart or graph Plant
data - the measure the following items against which shows an acceptable level of Mgr+Sales+c
intention for this targets and goal lines and look for satisfaction and a measure of each ustomer
element is to find areas to continually improve: customer to those goals. Look for levels service
evidence that that are below the goal for an individual
management is 1) customer satisfaction, customer and whether there is an action
measuring the plan to improve for that customer.
processes and
making
decisions based
on factual results
2) conformity of product requirements, How are product requirements spelled out, Plant Mgr +
of the analysis of
are they appropiate to the people who are Engineering
the data and
making and inspecting it? How is it being + Quality
information.
tracked?
3) characteristics and trends of SPC should be done. Look for whether Plant Mgr +
processes and products including there is evidence that trends in data are Engineering
opportunities for preventive action, tracked and whether improvements are + Quality
and ongoing based on that data and whether
out-of-control readings may be avoided in
advance of their going out.
4) suppliers. Are suppliers performance to requirements Purchasing
being tracked and is it accurate data. manager
Product & 8.1 none AEC will plan and implement the Engineering
process monitoring, measurment, analysis and + Quality
conformance improvement processes nedded to a)
demonstrate conformity of the product;
b) ensure conformity of the QMS,and;
c) to continually improve the QMS.
Definitions: This will include the determination of Look at some of the hourly check sheets Engineering
variable data - actual applicable methods, including on the floor, are the actual variable data + Quality
numbers derived from an inspection to be statistical techniques, and the extent being tracked with SPC or is it just a sign-
compared against known specification or of their use. off? If there is variable data being collected
control limits. Attribute - then it must be recorded on an SPC chart.
something that can not be measured, it is a go Attribute data can be on a sign-off sheet.
and no-go comparison (e.g. a visual
comparison, does it have 3 holes, or a plug
gage).
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 6 of 14
ADVANCE ENGINEERING INTERNAL AUDIT CHECKLIST for ISO 9001:2000 Date of Audit: Auditor Name:
MANAGEMENT ORIENTED PROCESSES (M.O.P.)CHECKLIST C/A=Corrective Action QMS=Quality management system
Objective Evidence Compliant
ISO 9001:2000 ISO Clause Procedure Requirement What to look for Who to go to Auditor notes Who Shift Y
8.2.4 none AEC shall monitor and measure the Are quality requirements spelled out in the Engineering
characteristics of the product to verify inspection instructions and are they being + Quality
that requirements for the product are done per the instruction.
met. This shall be carried out at
appropriate stages of the product
realization process in accordance with
the planned arrangements (see 7.1).
Evidence of conformity with the Do the inspection sheets have the Engineering
acceptance criteria shall be inspection item and the acceptance criteria + Quality
maintained. Records shall indicate the spelled out on them. Do they also have the
person(s) authorizing release of inspectors initials.
product (see 4.2.4).
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 7 of 14
Compliant
N
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 8 of 14
Compliant
N
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 9 of 14
Compliant
N
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 10 of 14
Compliant
N
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 11 of 14
Compliant
N
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 12 of 14
Compliant
N
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 13 of 14
Compliant
N
Form#: AEP 8.2.2-1A Orig. Date: 8/14/03 Revised Date: N/A Page 14 of 14
