# Audit point What to look for: Audit evidence: (Auditor notes) Nature of NC OFI

Compliance Status Status

1 Is key process equipment identified? List of Machinery & Equipment

2
Is there a developed and planned preventive Annual maintenance Plan
maintenance system in place??

3
Is Preventive maintenance conducted in accordance Plan V/s Actual
with the schedule?

Is the process or schedule for Preventive maintenance Procedure

4 PM Check Sheets
defined? Work instructions

5
Is any of the maintenance performed by an outside List of Service providers
service?

Procedure
6 What happens when equipment breaks down? Breakdown slip
Work instructions

Are resources for key manufacturing Critical Spare List. Random Verification for
7 availability of spares as per List. M/c Down time due
machine/equipment available? to non availability of spares

8
Are predictive maintenance methods utilized to keep Predictive maintenance examples.
equipment in good operating order?

9
Does preventive maintenance contribute to minimal Break down Slips
Breakdowns ? Machine History Cards

Do the Supervisors and machinists have access to Resources (Computer, Tools , Equipment, Work
10 suitable resources to plan, prepare and conduct instructions, Software , communication devices, Skill ,
preventive maintenance? Knowledge etc.)

11
Are maintenance objectives documented , evaluated & Records - Linkages between Target V/s Actual and
Improved? prevention initiatives - Mgt. review records

12 Is each maintenance man involved in machine upkeep?

13
Is there daily maintenance that the operator is
responsible for?

LEGEND : C - Compliance; NC - Non-compliance; S - Suggestion

 # Audit point What to look for: Audit evidence: (Auditor notes) Nature of NC OFI
Compliance Status Status

4.3.3.a)
How are the buildings, workspaces and utilities
maintained?

4.3.3 b) How is the process equipment maintained?

4.3.3c) How are the support services maintained?

4.3.3d)
Is the work environment sufficient for you to complete
your job?

4.3.3.d) How is the work environment maintained?

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LEGEND : C - Compliance; NC - Non-compliance; S - Suggestion

Audit Checklist
Process: Manufacturing Inputs = Actions = Outputs
Date: Auditor's Signature: Auditee's Signature: I.A. Number: Time:

# Audit point What to look for: Audit evidence: (Auditor notes) Nature of NC OFI
Compliance Status Status

does the operator refer to the router for the process

1 How is the process for your job defined? for this job?

2 What (inputs) do you get to start a job? operator should reference his job packet

operator should reference the router, drawing,

3 What work instructions are available? possibly some inspection documents

customer specifications are incorporated into the

4 Are customer specific requirements applicable? drawing

5 What other requirements apply to your job? tooling, gages, program, first article inspections

6 Are there approved set-up instructions? each machine will be different

7 Is the job set-up verified by anyone else? most likely not

Are you required to measure and inspect your own

8 should be done before calling for first article
parts?

this will be a variety, normally will be laying out in

9 What measuring tools do you use in the job? work area

10 What happens after your finish a run? should call for first article

11 Is there a reaction plan for Nonconformances? should mention that QC will document it on a QINR

operator should indicate he has this operation

12 What are the results of your job? (outputs) finished and parts are ready for next operation
13 How do you know what your next job will be?

14 What actions are taken during a power failure?

Is there a procedure to follow for starting the machine

15
back up after a power failure?

What do you do when your machine is not running

16
right?

Do you know how long it is suppose to take you to run

17
the parts you are running now?

18 Do you always run the same parts?

Do you have someone that works behind you on this

19 machine? How do you explain to him where you are in
the job?

20 What would make your job easier for you do to?

Audit Checklist
Process: Purchasing
Date: Auditor's Signature: Auditees's signature: IA No: Time:

Nature of NC OFI
# Audit Point What to look for: Audit evidence (Auditor notes)
Compliance Status Status
what they begin with - for purchasing the buyer will
1 Can you explain to me the inputs to your process? need a procurement

2 sales, projects
Who is your customer?

When do you learn what you will have to purchase for when a job has been entered and released? In
3 an upcoming job? How do you receive that supplemental contract review?
information?

4 What
determines who you buy parts or materials syteline - approved suppliers- supplier that has
from? proven they can supply what is needed and ordered

part #, grade, specifications for the product, price, if

5 What information is required on a purchase order? certs are required, any special shipping requirements

6 What
if the company does not have in stock your back order? order from another vendor?
item(s) to purchase?

7 What happens if the supplier sends the wrong thing or notified by receiver, written up on a QINR, then gets a
if required documents are not shipped? material return form (MRF)

after receiver, shipping docs are all gathered,

8 When is the purchase order closed and filed away? attached to PO, closed, then filed

they should be able to explain there method of

9 How do you rate your suppliers? determining critical and non critical suppliers

they should be able to explain the documents initially

10 What is required for a company to become a supplier? sent and arrangements for an audit

should say something about a completed P.O. or a

11 filled and received P.O.
What is the evidence of an effective process in your area?

12 How many purchasers do you have in your area? 3 plus Materials Manager?

13 Where are completed purchase orders kept? in a room in the purchasing area

14 How long does the system retain the PO's?

 yes, they can run all kinds of reports. Open PO's,
closed PO's, can look for NCR's, can run a report to
15 Are you able to run reports about late or back-ordered
purchase orders?
see where all they have a particular part number at
currently or in the past where it has been outsourced
to.

16 What is the process for returning a part or material to Should mention a MRF
a vendor?

17 Who
else in the company is able to generate a there are other people that have the authority to
Purchase Order? order without going through purchasing.

18 If
a supplier is utilized by a different NOV facility, does No
that mean you can use them also?
A quality manual and a way to respond to an issue
19 What is the bare minimum a company must have to be should it arise (some kind of corrective action
eligible to become a supplier? system)

20 Is
there anyone else involved in the rating process of hopefully will say something about Quality.
your suppliers?
Audit Checklist
Process: Sales Inputs = Actions = Output
Date: Auditor's Signature: Auditees's signature: IA No: Time:

Nature of OFI
# Audit Point What to look for: Audit evidence (Auditor notes) Compliance NC Status Status

1 How do you get information to initiate a quote?

2 Where do you keep the quote once it has been sent to do they store it somewhere?
the company that requested it?

3 How long is a quote valid? they put a time frame on the quote

4 How do your customer's initiate an order? phone, email, order after a quote

How do you know if there are additional requirements should say so on the order, but sometimes they
5 review what the customer has purchased in the
for the product your customer wants? past

the email, request for product, po; a statement

6 What documents go into a customer order file? that it was reviewed, a copy of the quote

7 What would be the reason that you would need a if it has additional requirements, gets marked,
supplemental review of the customer order? or is new

Who attends the supplemental contract review for your should be a representative from each
8 order? department

9 What types of information is discussed in a there is a document that gets filled out during
supplemental contract review? the review and is then signed

Is there a document that is filled out when you have a

10 supplemental contract review?
yes

What if the customer wants some additional

11 requirements on their order after it has been there should be an additional review
processed?

may have to go the the customer's web site,

12 How do you get the additional specifications from the may be sent by the customer
customer?

13 What happens with those additional requirements discussed during supplemental review
that the customer wants? How is that communicated?

14 What is the next step once the order has been put into is sent to purchasing and planning
the system? Where does it go from here?
15 Do you have any further contact with the customer should be interesting to hear this response
once they have placed their order?

16 What happens if the customer is not happy with their should be logged on the customer perception
order and calls to complain? log.

17 What closes the order? shipment

retained in the file room for the remainder of

18 How long is the order file kept? the year

they at one time had a review process that was

19 is there a method of review on the order files? suppose to be a preventive action.

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Audit Checklist Process: Sales - Projects

Input = Action = Output Date: #
30
Audit Point

Auditor's Signature:
25

What to look for:

20
Auditees's signature:

15

Audit evidence (Auditor notes)

IA No:
10
Time:

Nature of Compliance
5

NC Status

0 OFI Status
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Audit Checklist
Process: Sales - Projects Input = Action = Output

Date: Auditor's Signature: Auditees's signature: IA No: Time:

Nature of OFI
# Audit Point What to look for: Audit evidence (Auditor notes) Compliance
NC Status
Status

1 How is a potential Project initiated?

2 Is there a quoting process for Projects?

3 Where is a quote kept if it is for a Project?

4 Does a Project require additional resources which

would create the need for additional approvals?

5 If the customer makes an order, is there a review of

the order before it is accepted?

6 If there is a review, who is involved in that process?

7 Is there a single point of contact for Projects?

8 Where is the project file kept?

9 What types of documentation are required for a

Project?

10 If actions items are discussed in Project meetings, how

are these documented and how are they relayed to the
customer?

11 Does the Manufacturing Dept. produce deliverables

for the Project group?

12 Does the Project group have specific suppliers that are

used for specific services?

13 How are suppliers qualified to work with the Project

group?

14 What happens if a supplier is not accepted by the

customer for the service intended?

15 What happens if there are changes required by the

customer once a Project gets started?

16 When there is an issue during a Project, how is that

handled?
17 Are risks from previous projects reviewed when a new
Project is started?

18 What types of risks can affect a Project?

19 How many Projects can be handled at any one time?

20 Do you require additional qualifications or training

for employees in the Project group?

21 What is the average duration of a Project?

22 Is there a "lessons learned" meeting at the end of a

project?

23 If so, how is that applied to future projects?

Is there consistency in the handing of incoming and

24 outgoing document transmittals with each project
coordinator or assistant coordinator?

25 How is a project officially closed?

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Audit Checklist
Process: Planning
Date: Auditor's Signature: Auditees's signature: IA No: Time:

Nature of OFI
# Audit Point What to look for: Audit evidence (Auditor notes) Compliance NC Status Status

Is there a process flow diagram that adequately

describes the imputs, outputs, responsibilities, maybe there is one on the web portal, the cLink files
resources, measurement point(s), and other
requirements of the process?

4.4.3 Are the documents for this process controlled? yes, in teamcenter

4.5 Are the records for this process controlled? yes, per the quality records matirx

4
Is there evidence that management has reviewed this most likely yes by Mike Kucera
process during management review meetings?

4.1.4 a)
Are the criteria and methods of this process effective yes, this is a proven process
within the QMS?

4.1.4 b)
Do you think that management has provided we have a new building, new machines, adequate
resources to effectively carry out this process? office equipment, smart and knowlegable personnel

Are there adequate work instructions for the routers, drawings, test specs, inspection points, this
4.1.5.1 a is communication from one department to another
employees involved in this process? to an employee

8
Are there adequate job descriptions for the employees at this point, yes, unless we have a new job title or
involved in this process? description.

4.3.2.3 a)
Are there training records for the employees involved in there should always be a training record
this process?

4.3.2.3 e) Are training records maintained? yes, in safety and hr

4.3.2.3 d)
Are employees aware of the importance of their work in yes hopefully the understand getting it right means
meeting customer requirements? it will go out as planned, wrong = a delay

4.1.4.a) Howdo you determine what steps are required to processes are the stages the product goes thru,
4.1.4 b) whethere on site or outsourced. What it takes to
5.2 make this particular part? make it

yes, all jobs go thru the same processes- sales,

4.1.4 a, 5.2 Is the planning for this job consistant with other jobs? engineering, quality, manufacture…

When planning the job, are the product requirements

and objectives for the product taken into yes - drawings specs, different operations to make it
4.1.3, consideration?
5.2 b

4.3.1, Does the planning include processes that have to be if this part requires outside operations, then the
4.4.1 d) planner should mention that he stamps the router to
5.2 a done by outside vendors? indicate it is to be done outside.

5.2 f
Does planning include verification, validations and yes, inspection at various stages, assembly, testing, e-
monitoring? lab test, possible outside testing
 yes, a router for that product gets maintained in
5.2 Does the planning inclued records? syteline.

4.4.4
What are the controls for implementing external engineering builds external requirements into the
requirements? drawings and specs, -material/testing

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Audit Checklist
Process:
Date: Auditor's Signature: Auditees's signature:
# Audit Point What to look for:

Of all the things that happen in your department, are expect to hear new product design, new methods of
1 testing, improve current product, revise current
you able to prioritize them? testing procedures, drawings, markings,

How are responsibilities divided within the

2 department?

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 's signature: IA No: Time:
Nature of OFI
Audit evidence (Auditor notes) Compliance NC Status Status
t design, new methods of
roduct, revise current
ngs, markings,
Audit Checklist
Process: Customer Feedback & Perception
Date: Auditor's Signature: Auditees's signature: IA No: Time:
Nature of OFI
# Audit Point What to look for: Audit evidence (Auditor notes) Compliance
NC Status
Status

7.2.3 How are complaints tracked?

2 Who normally receives complaints?

3 Is there a process for handling complaints?

4 Does someone provide an immediate fix?

5 How are the complaints reviewed?

6 Is a root cause determined for the complaint?

7 Is that root cause documented?

Is a non-conformance documented when there is a

8 process failure?

9 What happens if the same problem occurs more than

once?

How is the customer kept in the loop when action is

10 taking place on his complaint.

11 What happens when the issue is determined to be

completed?

Is the information on customer feedback utilized in

12
any other process?

13 Who is in charge of documenting customer feedbacks?

14 Who documents customer perception?

15 Where is that information kept?

16 Who reviews the information that is kept?

Is the individual salesman that handles that

17 particular customer aware of the complaints,
feedback or perception that is logged?

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Audit Checklist
Process: Sales - Service - Projects
Date: Auditor's Signature: Auditees's signature: IA No: Time:
Nature of OFI
Q1 Audit Point What to look for: Audit evidence (Auditor notes) Compliance NC Status Status

Ask where you can find customer related processes

How does the QM define customer related processes? discused in the quality manual.
4.2.2

If the customer specifies a particular supplier or material, There is a procedure for Sales and Service. See if
5.6.1.1 there are documented meeting minutes. If in
how is this communicated? projects, should be in minutes of meetings.

There should be a material specification from the

5.6.1.1 b
If the customer specifies particular material/components customer. TOT should have an equivilant spec. Then
how is that information conveyed to Purchasing? ask what PO material was purchased on? Review the
PO.

How does the customer convey production and service This would be a requirement on a Project. See if they
5.6.1.1 provisions he wants used on his product, such as supplier have specifications that cover this for the job. Is it
production control and qualifications of personnel? listed on the ITP? In the minute meetings?

There should be a packing/packaging spec, along

5.7.1.1
How does the customer convey handling, packing, with specific shipping requirements. Is this
packaging and shipping requirements? documented in meeting minutes, e-mail, on customer
web site or web portal?

There will be a TOT drawing that will specify

4.1.5.2 How does the customer specify acceptance criteria ? acceptance criteria, or a specification for testing that
must be passed. Final QC sign off.

Purchase Order, specifications required for the

5.1.1 - How does the customer communicate his requirements to product or order. Could be priced from a bid
5.1.3 the company? previously done, if so, bid should be in the sales
folder.

How does the company determine requirements not

Engineering should question. Sales may question
5.1.2 specified by the customer but necessary for the intended from previous orders.
use?

5.1.3.1
How are applicable statutory/regulatory requirements Engineering will do a technical review.
defined?

Does the company go through a bid/no bid process? If yes, Yes we do quotes. Should mention a quote file on the
4.1.5.2 how is this done? Have we invoked any additional server, hopefull in the sales file also. Is there a time
requirements? frame for the quote to be valid?

4.1.5.2 How are bids communicated? In writing.

5.7.1.1, What records are maintained to prove conformity to Material test reports, IRC's, ITP's, Job Files, Routers,
5.7.1.2,
5.7.1.4 customer requirements? Testing Reports, PO's, Data Books, Final QC

6.2.1 How is customer satisfaction monitored and measured? (Feedback, Perception) There is a Sales Procedure.
 How does the documented procedure for feedback ensure
Check the procedure to see if it says anything about
6.2.3 customer complaints are considered as part of the early the data being used to prevent, correct or improve.
warning of quality problems?

6.3 a
How are customer related processes monitored and note what is measured.
measured?

6.4.2
What corrective or preventive actions have been executed Ask the Manager if there have been any previous
against this process? findings in the department.

hopefully they will tell you it is used to determine

6.3 a What is done with this data? customer satisfaction.

What evidence exists to show the data analysis has resulted Have they noted anything and then fixed it. Have
6.4.3 a they noted that it was improved? Have they
in Continual Improvement or preventive actions? implemented any preventive actions?

4.3.2.1 How is competency defined in this department

4.1.3 Are there any Quality Objectives for this area?

6.3
What do you measure in your area for continual
improvement?
Audit Checklist
Process: The Quality Management System
Date: Auditor's Signature: Auditees's signature: IA No: Time:
Nature of OFI
API Ref. Audit Point What to look for: Audit evidence (Auditor notes) Compliance
NC Status
Status

General Requirements

4.1.1
Has the company established, documented,
implemented and maintained a QMS?

4.1.1
Is there a documented commitment to improve the
QMS?

4.1.1 Where is the QMS documented?

4.1.4 a)
Has the company identified processes needed for the
QMS? Where is this located?

4.4.1 b
Where has the company determined the sequence and
interaction of the processes for the QMS?

How has the company provided resourses and

4.1.1 information needed to support the operation and
monitoring of the QMS processes?

6.2.3, How does the compapny monitor, measure and analyze

6.3 d) QMS processes?

Has the company implemented actions necessary to

4.2.1 achieve planned results and continual improvement of
the processes?

5.6.1.1, When we outsource any process that affects product

5.6.1.6, conformity requirements, how is conotrol ensured over
5.6.1.1 f such processes?

Does the company have adequate control over

5.6.1.6 outsourced processes to ensure conformity to all the
customer requirements?

Documentation Reqired

4.4.1 a
Does the company have documented statements of a
quality policy?

4.4.1 a
Does the company have documented quality
objectives?

4.4.1 b Does the company have a quality manual?

4.4.1 c
Does the company have documented procedures
required by the Standard and Q1?
 Are adequate documents in place to ensure the
4.4.1 d effective planning, operation and control of the
company's processes?

Quality Manual

4.4.1 b)1
Where in the manual is the scope of the QMS
identified?

4.4.1 b)1 Are any exclusions taken?

4.4.1.b) 4
Where does the quality manual contain or reference
the documented procedures established for the QMS?

4.4.1 b) 2
Where does the quality manual in clude a description
of the interaction between the processes of the QMS?

Control of Documents

4.4.3 How are the documents of the QMS controlled?

Can you show me a documented procedure that

4.4.3,
4.4.3 a defines the controls needed for approval of documents
prior to use?

4.4.3 b
Can you show me how the changes and the current
revision of the procedure are identified?

4.4.3 d
Can you describe how relevant versions are available
at the point of use?

4.4.3 c
Can you describe how the documents remail legible
and readily identifiable?

4.4.3.d
How are documents of external origin origin
identified and their distribution controlled?

How does the company prevent unintended use of

4.4.3 obsolete documents? Is identification applied to
them?

Control of Records

What records exist that provide evidence of

4.5 conformity to requirements and of the effective
operation of the QMS?
Can you describe the documented procedure defining
4.5
the controls needed for the identification, storage,
protection, retrieval, retention time and disposal of
records?
 Provision of Resources

What resources has the company provided to

4.3.1 maintain the QMS and continually improve its
effectiveness?

6.2.1
What resources has the company provided to ensure
customer requirements are met?
Audit Checklist
HR
Date: Auditor's Signature: Auditees's signature:
# Audit Point What to look for:

Human Resources

4.3.2.1
What are the education, training, skills and
experience required by this job? ( or task)
How do you determine the necessary education,
4.3.2.1 training, skills and experience for people performing
the work?

4.3.2.1
If you provide the training, how to you evaluate the
training?

4.3.2.2 How does this person meet those qualifications?

4.3.2.3 a) Do you teach them about the QMS?

4.3.2.3 c) How is the frequency of training defined?

4.3.2.3 d)
How do yu ensure that people are aware of how their
work affects meeting the customers requirements?

4.3.2.3 e) How and where do you maintain records on training

and where are they stored?

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's signature: IA No: Time:
Nature of OFI
Audit evidence (Auditor notes) Compliance NC Status Status
Audit Checklist
Process:
Date: Auditor's Signature: Auditees's signature:

# Audit Point What to look for:

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's signature: IA No: Time:

Nature of OFI
Audit evidence (Auditor notes) Compliance NC Status Status
Audit Checklist
Process:
Date: Auditor's Signature: Auditees's signature:
# Audit Point What to look for:

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's signature: IA No: Time:
Nature of OFI
Audit evidence (Auditor notes) Compliance NC Status Status
Audit Checklist
Process: Audit of Internal Audits
Date: Auditor's Signature: Auditees's signature:
# Audit Point What to look for:

1 Are internal audits conducted at planned intervals? Internal audit procedure, Audit Schedule

Do internal audits include all requirements of the

2 Internal audit records, audit checklists
Standard or Specification

3 Do internal audits include all the requirements Internal Audit Procedure

established by the organization?

4 Do internal audits verify effectiveness of processes? Is it noted in any audit report

Do internal audits verify continual improvement of

5 Are corrective actions making improvements?
processes?

In planning internal audits, are the status and Does Engineering get more attention than
6 importance of processes considered? painting?

Inn planning audits, are the results of previous audits Are previous audits reviewed to cover any
7 areas of concern that may have been
considered? documented?

Does selection of auditors and conduct of audits ensure

8 objectivity and impartiality?
Is the auditor independent?

How is it ensured that auditors do not audit their own Are certain areas untouchable for the Internal
9 work? auditor?

Is there an internal audit procedure and are audit Write the Procedure # down. Verify there are
10 records maintained? audit reports.

Do managers take action without undue delay on Do managers respond within the given
11 audit nonconformities? timeframe?

Do follow-up activities include the verification of CARS Check to see that CAR's have an area for
12 and the reporting of the results? verification and that it is being filled out.

Are auditors qualified to audit the QMS and its Do the auditor have training records? Check
13 processes? with HR

Do internal audit results contribute to mitigation and

14 Check the corrective action responses
or elimination of risks in processes?

Do internal audits contribute to successful

15 Audit records Linkage between audits
surveillance audits by the Registrar?

Do internal audits contribute to successful audits by

16 Customer audit records
the Customer?
 Do internal audit results contribute to continual Improvement initiatives, Management review
17 improvement of the QMS and it Processes? records

Are audits conducted in accordance with the

18 Audit schedule?
schedule?

Are audit nonconformity reports completed per the

19 Check the procedure
organization's internal audit procedure?

Are corrective action requests completed and issued

20 Internal audit procedure - Audit records
per the organization's CAR procedure?

Are Top Management and supervisors supportive of

21 Corrective action procedure, CAR log, CAR's
the audit process?

Is the information necessary for audit planning and Random interviews, Management Review
22 preparation readily available and accessible? documents

Do the audit prep documents and checklists show Company intranet, computer networks, Access
23 to QMS, procedures, process documents,
evidence of effective planning and preparation? records?

Do auditors have access to suitable resources to plan,

24 Audit preparation documents, audit checklists
prepare and conduct internal audits?

Have the Auditors received the proper training in Audit resources- computer, information,
25 accordance with internal requirements? communication devices?

Is the Internal Audit Leader qualified in accordance Training records, performance evaluations.
26 with internal requirements? Professional certifications

Training records, performance evaluations.

27 Professional certifications

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 's signature: IA No: Time:
Nature of OFI
Audit evidence (Auditor notes) Compliance NC Status Status

e, Audit Schedule

audit checklists

re

report

making improvements?

more attention than

ewed to cover any

ay have been

ent?

chable for the Internal

down. Verify there are

within the given

have an area for

is being filled out.

ining records? Check

tion responses

between audits
s, Management review

e - Audit records

dure, CAR log, CAR's

nagement Review

puter networks, Access

cess documents,

ments, audit checklists

ter, information,
?

rmance evaluations.
ns

rmance evaluations.
ns
Audit Checklist
Process:
Date: Auditor's Signature: Auditees's signature:
# Audit Point What to look for:

Are all raw material / component suppliers formally

evaluated? (Proper documentation)

Are corrective actions to problems managed

effectively?

Are floors free from excessive debris, oil, grease, water,

etc.?

Are gage calibrations up to date? Are they

documented by calibration stickers / calibration
reports / etc.?

Are non-conforming reaction plans documented for the

operator to see?

Are only things that are part of the process existing in

the work area?

Are rework materials marked and stored in clearly

defined areas?

Are there signed-off standardized work instruction

sheets at each operation?

Do daily maintenance check lists exist for machinery,

fixtures and/or tooling?

Does a formal preventive maintenance program exist

for machinery and equipment?

Does Management send messages / set goals of

continuous improvement on the shop floor?

Is in-process packaging adequate?

Is monthly Safety Analysis by department, Plant, Area

posted?
Is Rework Analysis by department, Production Plan vs.
Actual, posted?

Is Scrap Analysis by department, Production Plan vs.

Actual, posted?

Is the area clean with adequate lighting?

Is the company quality policy posted on the

manufacturing floor?

Is there a clearly defined system for equipment spare

parts?

Is there a clearly defined system for perishable tooling

replenishment?

Is there a formal problem solving activity that includes

operator input?

Is there a formal trouble log for each operation, and is it

readily available?

Is there a graphic showing the required production tools

and safety equipment needed at each operation?

Is there verification that parts are within specification?

Is upper management frequently on the shop floor?

's signature: IA No: Time:
Nature of OFI
Audit evidence (Auditor notes) Compliance NC Status Status
Read the procedure(s) before entering into the area for auditing.

Select 2 work stations, offices, machines in each process. Ask what they are working on, and look at the
documents in use.

Select 4 Documents or forms that the employee has at his job. You will want to get the employee to explain how
they know or can they verify that this is the lates revision of the documents. (Later you will Verify current release.)
Sales - ask to see the customer order file. Note the File #, Customer Name, Product, Pressure. Ask to see the
documents he(she) has to work with to get this part of the job done. Note the document name, control#, Job #,
PO#, Part #, Customer Order #, or drawing # that applies to the job.( review job packet, look at order, review the
sales file, project file. If the employee has white boasrd on the wall, ask about how it is used. Note if the board is
Select
used as5 reference,
Records, Verify
list ofto master
things list current status of his work, or a method to measure department work.
to do,

Select 2 gages, verify calibration date

Select 3 items, Verify evidence of inspection

Select 3 items, Verify evidence of records

Verify evidence of records for competency and verify that the position held is on the org chart

Select measurable form each process. Verify evidence of review.

Evaluate at each process, Verify evidence of records.

Evaluate and note cleanliness of area