INTERNAL AUDIT CHECKLIST

Issued by: QA Date: 00-00-00 Revision: A QF-82-02-3

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QMS
Performance
Data
Product/
Process
Data
Policies &
Directions
Policies &
Directions
Customer
Resource
Needs
PROCESS MAP
PRP 08
PRP 02
Sales &
Order
Processing
PRP 0
Inspection,
Test &
Metrology
PRP 0!
Receiving
PRP 0"
Inventory
Mngmnt
PRP 0#
Production
PRP 0$
Delivery
PRP 0%
Continual
Improvmnt
MRP 0"
Resources
Resource Mngmnt Processes (RMP)
Personnel
Competence
and Skills
RMP 0
Information,
Doc Cntrl &
Inf Tec!
RMP 02
"acilities,
#$uipment &
%ork #nvirmnt
RMP 0"
Measurement, Analysis
and Improvement Processes (MIP)
Customer
Complaints&
Satisfaction
M&P 0#
Control of
'C Product
Int (udit &
Analysis of Data
M&P 02
C&P (ction
M&P 0"
M&P 0
Purc!asing
Production
and )uality
Planning
Product
Design
PRP 0'
This connection between PRP 01 and PRP
09 applies only when custom product design
is included in contracts. Delete it if you
specify your own proprietary products.
If you are a subcontractor and never
design products delete PRP 09 and
move PRP 08 to its place. You need to
keep the connection between PRP 01
and, the now moved, PRP 08 only if
your contracts typically require
development of special, new production
processes.
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Mngmnt
Revie*
MRP 0
MRP 02
Planning &
O+,ectives
Market
Researc!
R")s, )uotes,
Orders
Customer
INTERNAL AUDIT CHECKLIST Doc: Q-!"-0"-# Revision: A Pg. " of $
This checklist is for Process pproach based internal auditing. It is divided into sections corresponding to the quality system processes defined in the Process
!ap. In this checklist the Process !ap is included on the first page, but in an integrated documentation the Process !ap should only be included in the "uality
!anual. The Process !ap and this audit checklist must call out the same processes. #hen you edit the Process !ap to fit your company, remember to also make
corresponding changes in the checklist.
This is also an I$% &''( compliance checklist. The requirements for each process are paraphrased from I$% &''( and there is a reference to the corresponding
clause of the standard )first column*. The checklist is carefully designed to completely cover all requirements of the I$% &''( standard. If, when customi+ing the
Process !ap, you delete or add processes, make sure that you re,associate the corresponding clauses in I$% &''( and don-t leave any out )e.g., maintain
completeness of the checklist in regard to compliance with I$% &''(*.
You should customi+e this checklist on three levels. (* align it with any changes in the Process !ap, /* further develop the 01equirements2 column to add other
relevant requirements )if any*, and 3* edit the 0#hat to look for and how2 column to make it appropriate to the products, operations, practices and issues that are
relevant in your company. The third item in particular will require the most customi+ing.
Product Reali(ation Process PRP 0 ) Sales and Order Processin*
I%& '00( Re)uirements *+at to loo, -or and +o. /omply Auditor notes and evidence
7.2.1 Determine product requirements
specified by te customer !including
delivery and post"delivery#$
not stated by te customer% but necessary
for specified or intended use$
statutory and regulatory requirements
related to te product$ and
any additional requirements determined by
te company.
How are customer requirements determined and
communicated? Are they documented? Who
processes this information and how is it done? Are
there written procedures/instructions and/or training?
Are there any requirements that are not stated by the
customer but are necessary? Are there any regulatory
requirements? Who determines, and how, what these
additional requirements might be? Are they
documented? How?
Check a sample of orders to verify that procedures,
instructions and/or training are being followed
!nterview employees and review customer complaints
to find out whether there is history of order
requirements that were misunderstood and/or
incomplete
"ote
#$es# for
complian
ce and
#"o# for
noncompl
iance
7.2.2 Prior to te commitment to supply product%
revie& requirements related to te product to
ensure tat
requirements are defined%
any discrepancies and ambiguities are
resolved% and
company is able to meet te requirements.
'aintain revie& records.
How are customer requirements reviewed, and by
whom? Are there written procedures, instructions,
checklists, and/or training Are there records
demonstrating that the required reviews are being
conducted for every order?
Check a sample of orders to verify that procedures,
instructions and/or training are being followed
!nterview employees and review customer complaints
and on%time delivery records to find out any cases of
orders that were shipped late due to lack of adequate
capacity to fulfill these orders
7.2.2 (ere product requirements are not !s it permissible to take and accept verbal orders? !f so,
INTERNAL AUDIT CHECKLIST Doc: Q-!"-0"-# Revision: A Pg. # of $
documented !not communicated in &riting#%
confirm te requirements before accepting
te order.
are these orders confirmed? How are such orders
confirmed?
Ask for records &copies' of the confirmations !nterview
personnel to find out whether they were consistently
trained/instructed to confirm verbal orders
7.2.2 (en canging or amending orders% ensure
tat relevant documents are amended and
tat canges are communicated to relevant
personnel.
How are change orders processed? !s there a system
for amending documents? Are there written
instructions, procedures and/or training? How is
information about order changes communicated to
relevant departments/personnel within the company?
(eview a sample of change orders to verify that
procedures, instructions and/or training are being
followed )ee if you can uncover any past problems
caused by mishandling of change orders
7.2.).a
7.2.).b
Determine and implement arrangements for
communicating product information%
andling enquiries% orders and cange
orders.
Are processes for communicating with customers
adequately defined, to include policies, assignment of
authorities and responsibilities, and methods
&procedures, instructions, training'? Are these
processes consistently implemented?
*erify that product brochures/specifications and other
product information &including the internet site' are
current
INTERNAL AUDIT CHECKLIST Doc: Q-!"-0"-# Revision: A Pg. 0 of $
Product Reali(ation Process PRP 02 ) Purc+asin*
I%& '00( Re)uirements *+at to loo, -or and +o. /omply Auditor notes and evidence
7.*.1 +ontrol suppliers and te purcased product
to ensure tat te product conforms to
specified purcase requirements.
How are suppliers controlled+ initial selection
evaluations, ongoing monitoring, audits of supplier,s
-.) and/or manufacturing processes, requests for
corrective actions?
How is purchased product controlled+ review of quality
records &)/C charts, inspection reports, lab test
results, etc', receiving inspection? Who makes these
decisions?
7.*.1 ,valuate and select suppliers based on teir
ability to supply products conforming to
specified requirements. ,stablis evaluation
and selection criteria. 'aintain records or
supplier evaluations and related actions.
Are suppliers evaluated and reviewed before they are
approved? What are the scope, e0tent and criteria for
evaluating and approving suppliers? Who decides?
How is the approval documented &an approved vendor
list'? Are there records of initial supplier evaluations?
)elect randomly and review a sample of supplier
evaluation and monitoring files !s their approval status
clearly authori1ed? !s their performance consistently
monitored? !n the event of nonconforming deliveries,
are they required to implement corrective actions? !s
there a follow up?
7.*.2 In purcasing specifications include% &ere
appropriate
requirements for approval of product%
procedures% processes and equipment$
requirements for approval of personnel%
and
quality management system requirements.
Where appropriate, are there requirements for
certificates, inspection reports, )/C data, approval of
samples, etc included in purchasing documents? Are
there any requirements with regard to supplier,s quality
management system?
(eview a sample of purchase orders, especially those
where the product is e0pected to come with
certificates
7.*.2 ,nsure adequacy of purcasing
specifications before tey are for&arded to
suppliers.
How is adequacy of purchasing documents ensured?
Are the documents reviewed before release? Are there
standard, pre%approved, specifications in the system?
What other methods are used?
)ee if you can uncover any past problems caused by
errors or omissions in purchasing documents
INTERNAL AUDIT CHECKLIST Doc: Q-!"-0"-# Revision: A Pg. 1 of $
Product Reali(ation Process PRP 0" ) Recei,in*
I%& '00( Re)uirements *+at to loo, -or and +o. /omply Auditor notes and evidence
7.*.) ,stablis and implement activities for
ensuring tat purcased products meet
specified purcase requirements.
What is being done to ensure purchased product
conformity+ certificates or inspection reports from
supplier or independent labs, )/C records, Cpk or /pk
requirements, in house receiving inspection, supplier,s
-.) certification?
)elect a sample of purchased product categories and
investigate for each what activities or arrangements
are planned to ensure their conformity, how this plan is
documented and communicated, and whether it is
consistently implemented
7.*.) (en intending to perform product
verification at supplier premises% define
verification arrangements and metods in
te purcasing documents.
!s this relevant? !f so, review a sample of purchase
orders or contracts to ascertain that product verification
and release methods are defined in the purchasing
documents
Checklists for the remaining 16 processes listed below are not included in the DEMO version of the software.
Product Reali(ation Process PRP 0# ) &n,entor- Mana*ement
Product Reali(ation Process PRP 0$ ) Production
Product Reali(ation Process PRP 0% ) Deli,er-
Product Reali(ation Process PRP 0! ) &ns.ection/ 0est and Metrolo*-
Product Reali(ation Process PRP 08 ) Production and Qualit- Plannin*
Product Reali(ation Process PRP 0' ) Product Desi*n
INTERNAL AUDIT CHECKLIST Doc: Q-!"-0"-# Revision: A Pg. $ of $
Measurement and &m.ro,ement Process M&P 0 ) Control of Nonconformin* Product
Measurement and &m.ro,ement Process M&P 02 ) &nternal Audits and Anal-sis of Data
Measurement and &m.ro,ement Process M&P 0" ) Correcti,e and Pre,enti,e Action
Measurement and &m.ro,ement Process M&P 0# ) Customer Com.laints & Satisfaction
Mana*ement Res.onsi1ilit- Process MRP 0 ) Plannin* and O12ecti,es
Mana*ement Res.onsi1ilit- Process MRP 02 ) Mana*ement Re,ie3
Mana*ement Res.onsi1ilit- Process MRP 0" ) Continual &m.ro,ement
Resource Mana*ement Process RMP 0 ) Personnel Com.etence and S4ills
Resource Mana*ement Process RMP 02 ) &nformation/ Document Control and &0
Resource Mana*ement Process RMP 0" ) 5acilities/ E6ui.ment and 7or4 En,ironment