PSX Audit Checklist Template-081512

8/9/2019 PSX Audit Checklist Template-081512

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AUDIT CHECKLIST

AUDITEE: AUDIT DATE: AUDIT REF: OK

Y/NITEM DOC. REFERENCE ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

Table of Contents

General Requirements........................................................................................................................................................................................................2

Quality Management System.............................................................................................................................................................................................2

Management Responsibility....................................................................................................................... ......................................................... ........... ....4

Resource Management.............................................................................................................. ........................................................................ ............... ..6

Product Realization................................................................................ ........................................................................ ...................................... .......... ....7

Measurement analysis and impro!ement................................................................................................................ ....................................... ........... ....."#

Q1 Section 3.1.4 - Control featureOrganizations documented method to perform an activity under controlled conditions to achieve conformity to specified requirements.

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General Requireent!

1.Organization has identified all exclusions that apply to the

QMS (limited to Sections 7.! 7.".#! 7.".$ %7.".&'

Q# Section #.$Y

Qualit" #anageent S"!te2.

Organization shall

a' )etermine processes needed for QMS

*' )etermine sequence and interaction of processes

c' )etermine criteria % methods needed to ensureoperation and control of processes are effective

d' +nsure the availa*ility of resources necessary tosupport the operation

e' Monitor! Measure! ,here applica*le! and analyze

processesf' -mplement actions necessary to achieve results and

continual improvement of processes

Q# Section &.#Y

3.Organization shall control all processes that are outsourced

Q# Section &.#Y

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$. )ocumented 1rocedures esta*lished and maintained forcontrol of documents

a' /pprove documents for adequacy prior to issue

*' 2evie, and update as necessary and re3approvedocuments

c' 4hanges to current revisions are identified

d' 2elevant revisions of documents availa*le at pointsof use

e' +nsure documents remain legi*le and readilyidentifia*le

f' +nsure documents of external origin are identifiedand distri*ution controlled

g' 1revent unintended use of o*solete documents andapply suita*le identification to o*solete documents ifthey are retained

Q# Section &.$. Y

7.Master list or equivalent esta*lished to identify current

revisions

Q# Section &.$..#Y

%.4hanges to documents revie,ed an approved *y same

function as original

Q# Section &.$..$Y

9.)ocumented 1rocedure for the identification! storage!

protection! retrieval and disposition ofrecords! and 2etention times esta*lished andrecorded

Q# Section &.$.&Y

10.)ocumented 1rocedure includes the functions responsi*le

for the collection and maintenance of records.(2ecords retained for minimum of " years oras specified in applica*le industry standard'

Q# Section &.$.&.#Y

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#anageent Re!&on!i'ilit"

11.0op Management commitment to develop and implement

QMS and continually improve effectiveness

Q# Section ".#Y

12.5ocus on the customer 6 requirements are determined and

met ,ith aim of enhancing customersatisfaction (7.$.# and .$.#'

Q# Section ".$Y

13.)ocumented Quality 1olicy *y 0op management

a' -s appropriate to the purpose of the organization!

*' -ncludes commitment to comply and continuallyimprove QMS

c' 1rovides a frame,or8 for esta*lishing qualityo*ectives

d' -s communicated and understood ,ithin theorganization

e' -s revie,ed periodically

Q# Section ". %

"..#

Y

14.0op Management esta*lishes quality o*ectives that are

measura*le and consistent ,ith quality policy

Q# Section ".&.#Y

15.1lanning of QMS carried out to meet requirements of quality

o*ectives

Q# Section ".&.$Y

1$.2esponsi*ilities and authorities are defined

Q# Section ".".#

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17. Management representative (mem*er of organizationsmanagement'

a' -s identified and has authority to ensure that qualitysystem is implemented and maintained

*' 1romotes a,areness of customer requirementsthrough out organization

Q# Section ".".$

1%.0op Management commits to esta*lishing communication

,ithin the organization (internalcommunications'

Q# Section ".".

19.Management 2evie, of QMS 4onducted annually ,ith

records of revie,s maintained

Q# Section ".9.#% ".9.#.#

20.Management revie, includes

a' 2esults of internal audits

*' 4ustomer feed*ac8

c' 1rocess performance (to include productnonconformity'

d' Status of corrective and preventive actions

e' 5ollo, up actions from last management revie,s

f' 4hanges that could affect the QMS (to include oil :gas industry standards'

g' 2ecommendations for improvement

Q# Section ".9.$

21.Management revie, output includes

a' -mprovement of effectiveness of QMS

a' -mprovement of product to meet customer needs

*' 2esource needs

Q# Section ".9.

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Re!ource #anageent

22.;uman 2esources 1ersonnel shall *e competent on the

*asis of education! training! s8ills and:orexperience

Q# Section 9.$.#

23.;uman 2esources

a' )etermine necessary competence (requirements'for personnel performing ,or8 affecting product

*'


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Product Reali(ation

27.0he organization shall determine the quality o*ectives and

requirements for the product

Q# Section 7.#a

2%.0he organization shall determine verification! validation!

monitoring! measurement! inspection and testactivities

Q# Section 7.# c

29.4ontract revie, ensures that

a' 1roduct requirements are defined

*' 2equirements differing from those previouslyexpressed are resolved

c' Organization has a*ility to meet definedrequirements

Q# Section 7.$.$

30.2ecords of the results of revie,s shall *e maintained

Section 7.$.$

31.Organization shall ensure amendments are made and

transferred to proper function

Section 7.$.$

32.4ontrol 5eatures for revie, of requirements related to

product

Q# Section 7.$.$.#

33.)etermine and implement effective arrangements for

communication ,ith customers

Section 7.$.

34.Organization shall manage the interfaces *et,een different

groups involved in design and development

Section 7..#

35.)esign output updated as the design and development

progresses

Section 7..#

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3$. 4ontrol features for the design of the product Q# Section 7..#.#

37.)esign development shall include methods! assumptions!

formulations and calculations

Q# Section 7..#.$

3%.-nput includes

a' 5unctional and performance requirements

*' /pplica*le statutory and regulatory requirements

c'


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43. 1articipants of revie, shall include representatives offunctions concerned ,ith design anddevelopment

Section 7..&

44.2ecords of revie, shall *e maintained

Section 7..&

45.5inal design revie,s shall *e conducted:documented *y

individual(s' other than the person(s' ,hodeveloped the design

Q# Section 7..&.#

4$.

=erification shall *e performed and results shall *e recorded

(Design verification activities includes one or more of thefollowing: a) confirming the accuracy ofdesign results through the performance ofalternative calculations; b) review of designoutput documents independent of activities of7.3.4; c) comparing new designs to similar

proven designs.)

Section 7.."

47.=alidation shall *e performed and results shall *e recorded

(Design validation includes one or more of the following: a)prototype tests; b) functional andoroperational tests of production products; c)tests specified by industry standards andorregulatory re!uirements; d) field performancetests and reviews.)

Section 7..9

4%.4hanges shall *e identified! revie,ed! verified! validated

and records maintained. /nd require thesame controls as the original design anddevelopment! and design documentation.

Section 7..7 %Q# Section 7..7.#

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49. +valuation of design changes on constituent parts anddelivered product

Section 7..7

50.4hanges require the same control as the original design and

design documentation

Q# Section 7..7.#

51.Organization esta*lish the criteria for evaluation:selection of

a supplier a*ility to supply product in accord,ith requirements

Section 7.&.#

52.

Quality records of accepta*le suppliers maintained

Section 7.&.#

53.4ontrol features for the purchasing process

Q# Section 7.&.#.#

54.4riteria for the selection! evaluation and re3evaluation of

suppliers shall include one or more of thefollo,ing

a' -nspection at supplier facility>

*' -nspection upon delivery>

c' Surveillance of supplier>

d' 4onforms to Minimum QMS

Q# Section 7.&.#.$

55.1urchasing documents includes a' products! procedures!

processes! equipment! personnel and QMSrequirements

Section 7.&.$

5$.Organization shall ensure adequacy of specified purchase

requirements prior to communication to thesupplier

Section 7.&.$.

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57. 1urchasing information to supplier includes type! class!grade! specifications! dra,ings! processrequirements! other data

Q# Section 7.&.$.#

5%.Organization esta*lished % implemented controls to ensure

purchased product meets specifiedpurchasing requirements

Section 7.&.

59.Organization has implemented controls for verification of

product at suppliers premises (*y itself or itscustomers'

Section 7.&.

$0.4ontrol features for the verification of purchased products

(receiving inspection'

Q# Section 7.&..#

$1.4ontrolled conditions include

a' -nformation that descri*es the characteristics of theproduct

*' /vaila*ility of ,or8 instructions

c' ?se of suita*le equipment

d' /vaila*ility and use of monitoring and measuring

equipmente' -mplementation of monitoring and measurement

f' -mplementation of release! delivery and post3delivery activities

Section 7.".#

$2.4ontrol features for production and service activities

Q# Section 7.".#.#

$3.1rocess controls include compliance ,ith control features!

plans! codes! standards! etc.

Q# Section 7.".#.$

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$4. 1rocess controls are documented and include reference tospecified requirements and acceptancecriteria

Q# Section 7.".#.$

$5.0he organization shall validate any processes for production

and service provision ,here the resultingoutput cannot *e verified *y su*sequentmonitoring or measurement and as aconsequence! deficiencies *ecome apparentonly after the product is in use or the servicehas *een delivered.

=alidation shall demonstrate the a*ility of these processes toachieve planned results.

0he organization shall esta*lish arrangements for theseprocesses including! as applica*le

a' )efine criteria for revie, and approval of processes,here resulting output cannot *e verified *ysu*sequent m % m

*' /pproval of equipment and qualification ofpersonnel

c' ?se of specified methods and procedures

d' 2equirements for records

e' 2evalidation

Section 7.".$

$$.4ontrol features esta*lished for special processes

Q# Section 7.".$.#

$7.Organization shall identify product *y suita*le means

throughout product realization

Section 7.".

$%.


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$9. Organization shall identify the product status ,ith respect tomonitoring and measurement requirements

Section 7.".

70.4ontrol features for identification of product as required *y

organization! the customer! and applica*lespecifications

Q# Section 7."..#

71.4ontrols shall include maintenance or replacement of

identification mar8s and identification records

Q# Section 7."..$

72.

4ontrol features for identification of product status

Q# Section 7."..

73.4ontrol of customer property ,hile under organizations

control

Section 7.".&

74.4ontrol features for verification! storage! maintenance and

control of customer property

Q# Section 7.".&.#

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75. 0he organization shall include

1re

servationof productduringhandling

1re

servationof productduringpac8agin

g

1re

servationof productduringstorage

1re

servationof productduringdelivery

Section 7."."

7$.4ontrol features for descri*ing methods used to preserve

the conformity of product

Q# Section 7.".".#

77./ssessment of product or constituent parts in stoc8 at

specified intervals

Q# Section 7.".".$

7%.Organization determined the monitoring and measurements

required and o*tain the required devices

Section 7.9

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79. 0he organization shall esta*lish processes to ensure thatmonitoring and measurement can *e carriedout and are carried out in a manner that isconsistent ,ith the monitoring andmeasurement requirements

Section 7.9Y

%0. Monitoring and Measuring +quipment shall *e

a' 4ali*rated against standards tracea*le tointernational or national standards

*' /dusted or re3adusted as necessary

c' -dentified to ena*le cali*ration status to *e

determinedd' Safeguarded from adustments that ,ould invalidate

the measurement results

e' 1rotected from damage and deterioration duringhandling! maintenance and storage

Section 7.9

%1. /ssess and record the validity of previous measuring results,hen the equipment is found not to conformto requirements

Section 7.9

%2. /ction ta8en on monitoring and measurement equipment,hen found to *e out of cali*ration

Section 7.9

%3. 4ali*ration records of equipment maintained Q# Section 7.9

%4. 4ontrol features to control! cali*rate and maintain monitoringand measuring devices

Q# Section 7.9.#

%5. +nvironmental conditions suita*le for inspection andmeasurements performed

Q# Section 7.9.$

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#ea!ureent) anal"!i! and i&ro*eent

%$. 4ustomer Satisfaction 3 monitor info relating to customerperception ,hether organization metcustomer requirements! i.e. customersatisfaction surveys! customer data ondelivered product quality! user opinionsurveys! lost *usiness analysis! complaints!,arranty claims! etc.

Section .$.#

%7. )ocumented procedure implemented to ensure QMS

effectively implemented and maintained

Section .$.$

%%. -nternal audits

a' 4onsider the results of previous audits

*' 0he audit criteria! scope! frequency and methodsshall *e defined

c' 0he selection of auditors and conduct of audits shallensure o*ectivity and impartiality of the auditprocess.

d' / documented procedure shall *e esta*lished todefine the responsi*ilities and requirements for

planning and conducting audits" establishingrecords and recording results.

e' /uditors shall not audit their o,n ,or8

f' 2esults *rought to the attention of the personnelresponsi*le for area audited for follo,3up

g' 4orrective action ta8en! implemented and verified

Section .$.$

%9. -nternal audits scheduled and conducted at least annually Q# Section .$.$.#

90. 0he organization shall identify response times foraddressing detected nonconformities.

Q# Section .$.$.$

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91. /pply suita*le methods of monitoring and measurement ofQMS conformity

Section .$.

92. Monitor characteristics of product to verify it meetsrequirements

Section .$.&

93. Monitoring carried out at appropriate stages of productrealization process

Section .$.&

94. +vidence of product conformity maintained Section .$.&

95. 2ecords indicate the person(s' authorizing release of

product

Section .$.&

9$. 1roduct release and delivery shall not proceed until plannedarrangements have *een completed

Section .$.&

97. 4ontrol features for required to monitor and measure thecharacteristics of the product

Q# Section .$.&.#

9%. 5inal (acceptance' inspection:testing is controlled *yindependent personnel

Q# Section .$.&.$

99. )ocumented procedure to ensure nonconforming product isidentified and controlled to preventunintended use or delivery

Section .

100. 2evie, of nonconforming product as repaired:re,or8ed tomeet requirements> accepted ,ith:,ithoutrepair *y concession> re3graded foralternative applications> reected:scrapped

Section .

101. 2esponsi*ility for revie, and disposition defined Section .

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102. 2ecords of nonconformities and any su*sequent actionsmaintained

Section .

103.


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112. )ocumented procedure required to ta8e action to eliminatethe cause of nonconformities to preventrecurrence

Section .".$

113. 4orrective action documented procedure esta*lished andincludes

a' 2evie,ing nonconformities (including customercomplaints'

*' )etermining the cause of nonconformities

c' +valuating the need for action to ensure thatnonconformities do not recur

d' )etermining and implementing action to eliminatenonconformity

e' 2ecords of results ta8en

f' 2evie,ing the effectiveness of the corrective actionta8en

Section .".$

114. +nsure that any corrective action is effective Q# Section .".$.#

115. -dentify response times for addressing corrective action. Q# Section .".$.$

11$. )ocumented procedure required to ta8e action to eliminate

the cause of potential nonconformities toprevent occurrence

Section .".

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117. 1reventive action document procedure esta*lished

a' 0o determine potential nonconformities and theircauses

*' +valuating the need for action to preventnonconformities

c' )etermining and implementing action needed

d' 2ecords of results ta8en

e) 2evie,ing the effectiveness of the preventive actionta8en

Section .".

11%. +nsure that any preventative action is effective Q# Section ."..#

F!" Q#002

$!e%a!ed &': Dae:

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PSX Audit Checklist Template-081512

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