ISPE-GEP

A

Good

'V

Practice

Guide

--

_.

_Good

Engineering

Practice

I

I

I

ISPE Good Prot;lice Guide: GoOcf Engineering Pr3.¢tice

Tabla of Contents

1

In

troduction

...•.•.•.•...

...•.•... 7

1.1 Overvie·w ... 7

1.2 Purpose ... 8

1.3 Scope and B~nefit Ol:l;OOtives... ... ... ... . ... 8

1.4 Koy Concepts ...•...• 8

1.5 Struccure of the Guide ...... 9

2

Breadth and Coverage

of

GEP

... 1

1

3

Good Engineering Practice

...

...•...

13

3.1 CO<eCo~ ...•...•... 13

3.2 Pro~ Engineering ..•••••..•..•.••...••••••••..••••....•••••.•..•..••...•...•..••••.•.•...•••..•....•.•...•••••...•...•••.••... 15

3.3 CO<nmon Pracli<:es •..•••.•....••.•••....•.•••...•.•••••...•...•.•..•.•... 24

3.4 Operations and M-alnlenanee... . ... 32

4

Appendix

1

-

Explanation of Example Engineering Management Process ... 39

5

Appendix

2 -

Gl

ossary and

Acronyms ...•...•...

... 41

5.1 Glossary... ... ... . ... 41

5.2 Acronyms elld Abbreviations ... 43

6

Appendix 3 -

Ref

erences

...

... 45

Pagee 1$PE Good PfO<IIoe QoiOe: Good EAg!neeMQ Prootk:e

Tabla or Attachments

Introduction to

the Attachments ... 47

Attachment

A

Principles of Good Engineering Practices

... 51

Attachment B

Project Quality Planning

...

... 59

Attachment C

Project User Requirements Specification (URS) ...

_{... 71}

Attachment D

Project Risk Analysis ...

₇₇

Attachment E

Cost Management and Repor1ing ... 83

Attachment

F

Site Development Plan

...

... 89

Attachment G

Project Execution Plan ... 103

Attachment H

Project Change Control.

... 105

Attachment I

System user Requirements Specificatron (URS)

...

113

Attachment

J

Design Rovlew ... 121

Attachment K

Maintenance Test Cer1ification

...

...

...

131

Attachment

L

Facility

Commissioning

... 137

Attachment M

Project GMP

Assessment...

... 145

Attachment N

Setting System Boundaries ...

...

...

... 153

.

Attachment

0

Commissioning Plan ...

... 157

Attachment P

Commissioning Plan Compressed Air Supply

... 165

Attachment Q

PM Completion Checl<list

...

...

...

...

181

Attachment

R

Audit Template

...

... 183

l

I

I

I

I

_~

I

I

I

_t

I

ISPE Goc:::4 PractiCe GuidEr. Good Engineering Practit~

1 Introduction

This ISPE Good Practice Golde alms to provSdo a deflnit.k>n and explanation of the tenn "Good Engineering Practice" (GEP). It doscnOes the fundamental elements of GEP as they shoufd exist in pharmaceutical and related industries. it should be noted thet the conc~epCs are fundamental and applicable in many indust~.

1.1

Ove

rview

In tM oonteXt of pharmaoeutieal engineering and GxP guidance. GEP is frequently referred to in documents as a prerequiS-ite to compliance activity and may be loosely defined. GEP ia often used to describe an engiM&~Ing man&gemef'lt system that is expec:t6d in a regulated company, but which Is not mandated by GxP rcgu!atk>ns. For example, effecliva project progress monitoring and controt is not a regulatory issue, but is neoessary for the efficient operation of a company. and Is part of GEP.

This Guide oonsiders the entire range of phsrm:aceuticel engineering activity and klentifies key allributM of GEP within it. including how GEP recates to, and interfaces wilh GxP. The scope of GEP covers the compfe!e life cycle of engin&efing from concept to retirom(lnt. GE.P provides a tout~dalion t&QtJitcd across the pharmaooutical industry upon wf'lieh othet atoas, such as GxP, build.

Figure 1.1: Postttonlng of GEP in retatlon to GxP

The aspects of GEP discussed in this GuKfe are intended to deS<:ribe the minimum requicernent$

ror GEP

in engitteering activitres.

P•o••

ISPE Good ProeUco Guide: Good Eng;noeolng p , _

Figure 1.2: How this GPG fe:t~tet: to other ISPE Technk:al Documents

Tho - running of a buolness, demand$ woo1clng pr11dlces wl1ich will

d-

()9UnUm vob> for a g'-> oc:cpe of """"- lhl$ g<.-ls by Its nah.n

geoonc and speclle

requil1lml!flls wB need 10

t>e oeteded

and adapted.

1

.

2

P

urpose

Thl:s document was devaloptd lhrough the oof!abofaOon of representatiw professionals from various seetore and geographie regions of ttle photm.9oeutieal industry whh the iltentiOn of CSetermlnlng 1 common understanding of the concept and principles ol GEP.

This CIOrument identillos praclloes

""'ich

exemplify,_ GEP

ccncepcs

may t>e appllad In 111e pllatrnaceullc: fndllllry.

1.3

Scope and 84!nef

l

t Objectives

Tho &eope of this Guide is limited to the hoallhcare lnduslty but oonslders all aspec11 of e~ineerlng. The motives for asp!rlng to pOOice .. good ong1neering" are wider than tho Med to comply with GxP JegulaiOry expectations and onoompass prooludivity and buslooss related driveR.

Tlte odop1;on ol GEP slu>uld

-to

a

-.ce

of ex~ and -.oily in - 10 - Benefil is , _ li<efy golned when ftnlte ltiC<IroH oro focused on ldenlillecl hlgller ri$k aspecb.

1

.

4

Key Concepts

I

tSP'E Good Practioc Gtlidc; Good Engineering Practice

common

praclioes

opetalion and maintenance

Project Engineering: The aQivities associated with implementing new Qf significantly changed equipment or facltltfes; lypically associated with &.!location cf capital funding and additional resouttes.

Common Ptactic•s: Thos& ptactices with fetevance to t::oth project engineering and normal operation and maintenance

Page9

oporatlon and Maintenance: The sctivibes required to sustain equipment and facilities in a satisfactocy cooomon and use them for production purposes.

Common to these three key concepts are th& further key concepts of "risk management." •eost management.~ and ·organization and oontrol:~

Risk management the systematic application of quatity man&9&ment polf<:ies. proeecrures, and practices to thG tasks of assessing, controlling, communicating, and reviewing ri$k (see ICH 09, Raference 1, Appendix :l). Risk management Is at the core of most GEP actlo,~lty.

Cost management shoukl ensure that the <lO$l impact of any activity is understood, assessed. and managed. in order to retum best vatue for the regulated company. Value is measured as a balance between cost, quality, and progress.

OrgtmiZation and control: organiz3Uonal structure shoukl ansure maximum efficiency and that the ovethead to output tatlo Is acceptable. Control mecharu:sms within an organization shookl monitor the performance an<f progress of assigned activities. A -clear structure of organization and control is required to respond effectively to the changing derna.nds of the business.

Key1erms: Soppller

An organization or individual internal or external to the u~ associated with the suppfy andlor support of products or services al any phase throughout a systems lite cycle.

User

The phamlaceutlcal customer or user organization contracting a supplier

to provide

a proclucl tn the context of this document it fs, therefore, not intended to apply onty to individuals wtlo use the system. and is synonymous v.ith customer.

1.5

Structure of the Guide

The structure of tile Gufde dlvkles GEP actl\lity Into project engineering, common practices and operation and maintenance. Each section of this Guide is prefaced with the definition of the key concept. Within eadl of these section$, practices and sub·prectioe$ are identified and described co provide iUosUatiYe examples of GEP.

JSPE Good Practioe Gufde: Good ~!ng Ptacclot

Page 11

2 Breadth and Coverage of GEP

Agure 2.1 illustrates the breadth and coverage

ot

Good Engir')Q:Q11ng Pmcuoos In the diSciplines of Project Engiooertng (blue), Operations and Maintenanco (green), and practioes Ulat are common between tho t\vo (toal). Cote Concepts which permeate all aspects or Good Engineering Practices also are indicated.

1SPE Gtt<XI Praotioe GIJOO: GooCI Engtnooring Praclioo

P•ge 13

3 Good Engineering Practice

3.1

Core

C

o

n

cepts

3.1.1 Risk Management

Risk management is at the core of most GEP ac:tivi1y $uCh that there Is a balanced evaluation of risks against benefits:. Where pr9cticable efforts should be made to 'design

oUt

or minimize identified risk.$ to an acoepfsbfe

tev

.

e!

.

.

.

Sub-Practice 1: Identify

A regu1ated r;ompany shoukt identify $ignificant risks whldl may threaten

tts acti'lities.

Sub..Practlce 2: Evaluate

Risks should be assessed using approl'fiate methods. to determine H they are forlg or Short term. The threat !ev·el should be evaluated, considering likelihOod, sevetlty of c:onsequonces, and pcobability of detection. It shovkl be understood that risk i!i an in1egral component of all activity and it Is necessruy to accept a certain level of risk in order

to

fvnc::tion. Risk a$SGS$ments should be petformed by app(()IXiat&ly sJ<jled personnel.

Sub-Practice 3: Document

Some level of documentation is always appropriate to capture th.:t thought processes and the log~ involved for communicalions and fu1ure ref01enoe. Ttle signincance of the risk to the business and purpose shol.lid define the level of documentation involved. Wherever poss!b~ established assessment and documentation processes be should bQ use<!.

Sub-Practlco 4: Mitigation Str;.1tegy

Risk management $hould include baCk op sttategles. condngancy plannJng, anct risk mitigation. Examples of ri.sk and mitigalion indude:

back up of key computer systems and data stand-by power ge11eration

redundant capacity tor steam, air, aM gases

lnsutance f()( unmitigated risks safetylsh.t..ltdown systems 3.1.2 Cost Management

Cost management Is a key aspect of good engineering practlce ensuring the cost impact or any actlvlty Is undetstood, assosS4d, and managed In order fo return good value. Value is measured as a balance between

cost

quality, and progress.

Page 1• ISPE Good Prbelloe Gulcll:

Good Engileemg P

-A tegut.ated oompany shOuld have an Mtablished system for obtaining an lnltlal C0$1 estimate for a ~ scope of wort in otdef to ev-aluat& its viabll:ty. Througtloutlhe ccusa of the actMty the Kltmale shOuld be updated and expenditut& ttacked to predict final coat o.nd ai\&UI'e contmulng viabifiry.

Sub-Practice 2: Planning

The appropriate leetlnieal and angklMrtng (Separtmel\ls should wotk wtth 1he riooncial and oontract department• W develop models doterminiog contract stratogy, factotlng In nee present value, moneta.y cost. Return on lnvestmenl (ROt), ond cost of aa:e!eraliool. The rolnllonshlp between schedule and cool should be understood and opUmiZed lor -ROt.

Sub-Pracctca 3: Ratum en lnvestmont

The relatb"'shlp between the 006ts ol an IICI.Ni1y and the ROI should be understood li'ld used

to

provide a ratlonalo for procoodlng during eac:h stage

o

r

dovetopmont.

Sub•Practice 4: Front End Lcwsdlng

CommiUing more cM:ources in the planning and design stage of a project moy Improve design coordinetion and detln!Uon. and. therefore, help mln1mlza the risk of oost and schedule overYun.lt

may, however

, seem to slow down progroos during the early s1ag9$ cia PfO)ect.

SuW,.actiGe 5: PaybaCk Polley

ROIIIloufd be st.C>ject

to

rules delotmtnlng occepiBble payback periods ""'"l"ll'blo W>lh a regufaied ~y's lnvennont and long tam busa-tess attotegies.

Sub-Practic• 6: Cost of Ownorshlp

Tho full cost of ownership. including operating costs. dooommissioning and dlaposal costs should be oonstdered in

i

nves

l

r

n

en

t

decisions.

Sub-Praclk:e 7: Cost Control

Cort otlima1ea ShOtJid be &nalozed at delign -oval. Conltds shOUd be

e s - 1 0

ensure thalal proposed c:llangosiO an

-oved

design or. osseaaed fer 0051 and sche<rule lmpeclln a llmofy mamor before 1l1ey oro Opl)fOYICL

3. 1.3

OrrJan/zarlon

and Control

A dQ:(II strvduro of ot9'10izatloo and control is reQuired to respond eff&etlvetv

to

U')& changing demands of tho

bualnoas. ·

Sub-PrectJce 1: Clear Structure

Reponlng relationsl1ips and responslbl ties within o regulated company should be clearly undOf'SIOOd and dooument.ed. The usa ol mablx ~ 1o< a ~ acll\ll!y may -Sne or amend lhe relatlonsl1ips, so

lhould be used only Y>tlen dear

t8ll"'11no

lineo "'"defined. Sub-PractJeo 2: Review

Regytaled oomP811ies shcluld perlodlcelty review their <Wganiuriional 51ructuro

to

ensure maximum ef11elency and to ensure th.allhe overhead to oulput ratio Is acceptable when compared to slmitor reQ\,IIated companies.

!SPE Good Ptac:!!ce Golde: Good Eng;~Mering Prt~C:IiOO

Sub-Practice 3: Monitor

Control mechanisms within a r~ulated compa.ny shOukJ monitor the pe-rformance and progress of assigned activities.

3.2

P

ro

ject E

ngin

ee

rin

g

3.2.1 Project Infrastructure

Page 15

The n!gulated company should organize its project engineering activities aooording to defil1ed proced~es and

processes.

Sub-Practice 1: Defined Organiution

For QaCh pro}ect. reg~Jiated companies should have defined project groups with clear decision making responsibilities and fiMncial authority. Key stakeholders should be identffied, and should have ownership, aocoontablity, and responsibility for a project and its outcome.

Sub-Practice 2: Defined Procedures

Regulated compan!as shOutd have defined procedUrGs. to cover the anticipated range of projects. including appropriate governance procedtlfes, either on a general basis or for an individual projecl. These procedures should Include the project group strvcture. reporlin9 structure, and inclu<le a documentation slrategy. desctibirlg:

retention and storage criteria

planning. progress. and cost reporting

change control (appropriata to each Sl$98 and activity)

design ISV~'IiS quality control

For an example

ot

GEP guidance and project quality planning guidance refer to Attachments A and 6. Sub-Practice 3: Assessment

Regulated companies should ensure that project objectives. (e.g .• process. product, and equipment) are defined

cfvring the ear1y stages of

a

proJect, and that subsequent methods arld proced1.1res are established for the application

of risk. and impact assessroools to identify and mitigate identified ris~ to a project's objecUve$. Sub-Practice 4: Scalability

Regulated co:npanles should ensure that project groups. pcocedures., and t&spoos£bl!ltfes for a project are a.wropriate for the size and type of proJect actMtles and the Impact of the project on GxP regulated systems,

Sub-Prectlco 5: Approprhtto Staff

Ragu&eted companies shoukl ensure that project personnel are si.Jitably trained, resouroed. and supported in

Page 1t ISPE GoOO Pruc:tJco GuiQe.

Good En;,..~ Practice

3.

2.

2

Project Organization ..

The managom-" o1 projectS whhin a regulalod company ehO<Jid be an «ganized, dofinod activity, dri""n by the

""""

·

to ad>leve

cottand Q!Jal;jy offodlvolm_.,m. SUb-Practice 1: Project ldentiflc:at1on

Regulated compeniea shouid havG systems fOt recurring reviclw of current and tulure requirements against CUrTent

cspabaltles and available technologies. This Information shoutd bo used to iden1ify lho need and justification for

Change

.

Sub.Practice 2: Profect Definition

Rsg!Aated ~nioa should haw !Md\anlsms tor the review ol pn>POSfld ch311Q0S ond a me<i1<>d ol defining ll1e ocope ol WO<k (e.g .• Usor Requirements Spgclfic3tlon (URS)).

For an e.xamplo of 8 high level project URS refer to Attacl\ment C.

Sub.f'raetlcol: Project Approach

Ragulated ~amos should ensure that oppropria!e memocts. such as risk asse'~ and i~ asaft.Sments.

are used to eotob"h tile OI)Onum approaeh too projeec. The opproac;h edopted should consider the fu'l L'M o'j<)le

nod asaoc;iated rls.ks. e.g .• the lowest ln.tlal cost option may nol be optimal m.Je to h""'er operotiortal oosts or oChQr significant risk racton.

In an axtended proje-ct. sueh decisions should be re-evaluated basGd upon a pre-detormlned schedule.

Regulated oomi)Mios should hallll mechodo to determine tile mo•tat>P<oprlale approach lot Implementation ollhe

project with both ll budget atld a $Chedule. Sub.Practite S: Project. Management Rosources

Regulatod

OOfllPOillos -

ef\$Ur8-ptqed• haw

- t o

odequa!l> """""'" lndUdiog lo< ... appropriate personnel. OJimmunieatlOnS, f\Jnding, offices and aystem$.

3.2.3 Value Analysts

A r09.dated oompany should have defined methods of rational decision making rego.rd!ng the imp!ementotton Of

P'*.ds

boied

upon

tl>w

o!>iily

to

ylold wtue. Sub-Practice1: ROI and Risk Analysis

Regulated companies should assess lhe ROl and consldor any pocentlal risks and beoorrts to determining the vklblflty and manner of oxooullon of the project Th9 need for timety execution and the ri~s os&ockttod with felure thoukl be

dMtly underetOOd by stakehok:ler..

SutH'ractlee 2: SuppUer Selection

Ragulat9d oompankts tthoutd ensure that appc()l)tlate methods am O&tablish&d to &asess and select svpp!iora based

ISPE Good PraetJc~> Guide: Page 17

Good Engineering Pra¢tiCO

quality

costs

experience technical support scope of wort( $Chedule

Sub+PracUce 3: Cost Contr~

Regulated companies shoiAd be cspab!& or estimatittg the anliclpal9d costs of projects, reviewing and controlling them during ptojoo:t imptem&ntation on an ongoing basts.

For an example of

protect

management guidance refer to Attachment E. Sub-Prac-tice 4: Value Engineering

Regulated companies should have systems for reviewing proposed solutions against the def.ned project requirements

to ensure that adequate quality is delivered at optimum cost. The total life cyde oo-st of any proposed solution should b& oonsfdered In this review.

3.2.4 Planning and Monitoring

1:'/:'!&.:.<"1''~~"'-·:..·-.;·~;.."?">:"'f':l_"" •. :~·, ;:i':.:"·~~ .. :.-·.-•.-...:· :I:.:·;.,~'·~",:'-.:-.. ;--'·'·· . . . . -;_. ... . •' ~-·-... ::,:_~.::~-"!"-' ... -. t~6!!.~,~~~~F~!~!".Y,~o~!~~~a~. ~~lOri~ .t~fm. ~Si~;&-~ s~:a.t~ .. ~t\lq!l·~~~ ~n~!uOO forrn_al·~~e/~a,l1i~~n· · r~.lan~'1,:rt~e~.~.~d.~;a;!~.f~~~.,.t_!le~-f)~~elop~g.~;Pr?~ pl~n.t?:~hleve;th~--~~flne:c'·~~~~!~·:·;·,I

:

;.,

.·.

f·

re.v

l

eWJ

.

ng-

th

em

'

aga

!

n

s

.

t

.'

ttle

.organizatio.o-strat~ieslplanS. wlth~

a means.

,of.roon.iforing·

p

roj

ect

progre.$$ ~.ainst·

·

~

~

~

i

K

~

i

_

~!

·.

~

~~~

::~~~~~1~f~.;t~~:{t~~~~·,~1k.~J;

.

{~~f·~,~-~:~~~:r~:i~~:-::p;~~:~:,;-~::·":

;;

.

.

~~-~~,.;:~~····~~

..

~:

:

~~:r-:;·:~-.

,;;,,,·"'::'·;·-

~.,:

·

Sub .Practice 1: Long Term Strategy

Rogulat!MI compank!s should havo long term business strategies. wfllch may include formal $il:e master peens. These should be reviewed and re~Jised as required to ensure that they reflect the commercial and political environment. For an example of a strategic ptan refer to Attachment F.

Sub .Practice 2: Project Pl

a

n

ni

n

g

RegulaiOO companies should t\ave systems for developing project plans., which define: timolioos

me!hodo!Ogies

resource requirements

._18 ISPE Good PtdCtie$ Guidi: Good Engineering Practice

Sub-Practice 3: Projeet q~Hty Planning

Regulated companies should ensure project qua~ty plans cwe available and appropriate f<W tne proposed pro!ect. and managed in accordanoe with an agreed project $Chedule. The pro;ect quality plan should define acceptable quality standafdS snd ho\v thGy wiD b9 achieved and assessed, e.g., includetsvlew stages, approval, and quality management or supplicts.

For an examp}e of project quality guidance refer to Atla<:hment B. The pro;ect quallly plan should cover:

change control pr-ooass and implementation

the application of the risk management slratagy (heM• to manage risks and when 10 pertonn assessments) document checking, revie.,, and approval before issuing at pre·deflned stages (e.g .. concept. approved for design. and approved for construc11on)

docurMnt numbering and version oontrol equipment a.nd instrument idenUfieaUon design and progress tevlews

documet~t distribution and control Sub~Practi<:e 4: Monitoring

Regulated companies should have systems for !det~tifylng the most appropriate means of monitoring progress against the project plan.(ongoiflg costs. work progress, activities completed) and for predicting final cost and comple!kln data. This Information should be regularly communicated to lhe key 5-lakeholders (e.g .• uset$, seniot management, and finance dopartmonts).

Sub·Prac11ce 5: Change Management

Regulated companlos Should have systems to.r recognizing the need for change within prQject activiUes.

,

.

A dlange management system should have a method for timely reviewing of cl\ange options 8Jld de-termining the most appropriate course of action. Tile change management system should revise and amend the scope. schedule, and budget to reflect the selected outcome. The change and ita potential Impact should be communicated to the key stakehck:ler& (e.g .. users. quality department, project oost oontrot, and senklt management). The change management systam. ~nd associatod review ~nd approval method, shoukl be adapted to the project stage and regulatoty impact, allowing effective aod rapkl change controL

For an example o1 project change cootrof guidance refer to Attadlment H.

3.2.5

Design

Th$ regulated comPany.shoufd have a structured design process

to acttieve

the optimum vatue in relation to the

'proje_C1 size and scope. · · · ' ·. '':.+'

ISPE Good Prect)cE Guide: GoOd El'l(lineerllg Procllce

hge19

Sub.Practlc:o 1: User Requirements

RegU'Iated companies should have estabtished methods for developing and reviewing a rcnnal User Requirements Specification (URS). capturing both the fundamental aspects and scope of tho users' roQUfroments. Users shoukl be involved as muc::h as possible in this process. As a minimum, users should be requlced to review and epprove these requirements. Requimments should be objectively stated such that they can be verified during testing ;:md ccmrnissioning. Alignment with objectives of any company strategy or ma-ster plan should be confirmed.

Requireme.nts should be focused oo prodt.'Ct and process requ:ir~nts and as far as poss!tl!e ~ave engineering aspects open for subsequent definition.

URSs vary immensely In their seop& and comple>lity: examples and approaches for equipment may be ~en at the JETT Web site hosl10d by ISPE (se<o ReferenceS. APilen<lix 3).

FOJ examples of a nigh level projecl URS and a more cSt;tailed sys-tem URS refer to Attachments C and 1.

Sub·Practice 2: Design Dev~lopment

User requlretnents should be ,\.rritten in measurable terms and shookS be used as the basis for dEM~Ioplng project spe(:ifications and drawitlgs.. Usets and designers should determine appropriate iterative design stages, with increasing project definiOOn. at which a pro;ect can be r&vlevred. This process should enable increasingly acc::urete cost and schedule estimates and maintain quality,

The stages at which the project design should be roviev1ed will vary aooording to tyl)&, scale, and risk. Each stage, typically, will requiro a further contractual commitment by the owner Ol t\is agent

Stages typically wil include:

Initiation (definition ot pro{ect goals and klltlal ptoject URSs}

J.U$1.lficatlon (confirmation of the business case with definition of eceep!abte project cost)

GxP VnpacVrisk a.sse:SSmenl (understanding how much additional effort Is nocossary to vGrity formany the system)

Design Acceptance

Execution (design development through to the stage of Issued for Construction (IFC) draw!ng:S and specifications)

For an example of a design reviewlemp!ate refer to Attachment J.

Sub .Practice 3: O&&lgn Delfverabi(IS

,

.

The structure and tevet of detail in the design de1Werab4e:J will be determined by the chosen oonttact strategy, acceptable de.gcee of risk. and the size and make--up of the project support team.

Fot each stage of a pro;ect, specific deSign d&livefa_bfeS wl!.l vary acoocding to the project. and may include:

concept drawings: SB<::Iions.: layouts material fiO\V, personnel flow and process flow

lntarmt!dlato stage: OOve~pment of Process and lnsuumentation Oiagrams (P&IDs), preliminary equipment specs. ootfioo architectural drewtngs

Page 20

final st.aga: detail droV~!'QS specifications and purchase orcters

fSPE. Good Practice Guide·

Good Engitltee:ting Practice

specific local documentation d&liverables tor compliance with regulaUoi'I<S (e.g .. health and safety (EHS) regulaOOns. pressure regulations) and obtaining approvals

3.2.6

Design

Reviews

T

~

~~la

-

t~

-

~~

~

x

·

s

·

t)

~·

~~~--~ve

~~~

~.-

SY.st~rn

··

f~

·(ev

i

~

wl~

.

U.~

·

d

e_s~

;·

~

n

s

t

.

~bj

~

ti

yes

fo

en

:~~&

~

th~

t

... adG.qua~_qu~fJ:tY.-is:Qe.liVerSd a·~ 9{>1irflum cost.:~: •j~.

>:;,

_

,,.,

'.' ·

~

·

··

· ·

:~

: · · ·

·

·:

'

·

·

-;:·· ... ·: --' • :.f,_ •• .~ .. ···; •:·;_ •.••• ·~~- •• --~ ._; ... ..,. .. .,·•:_,-;. Sub-Practice 1: OGslgn Quality Control

Usets: shOUld agree with desigoefS a system for quality 0011trol o1 drawings, speclflcatioos. and cak:uJations. typically defined In a project quality ptan.

Sub.Practice 2: Design Review Stages

ThA design should be reviewed at preo<lefined staS)eS and approl)fiately documented during development targeted to addr~s specific isSUe$ such as:

does the design

meet

the defined usor tequirements

concept raview to considct basis of dosign and its suitability for: delivery ol expe<:tatiooo

site location B'lailable materia!s local technology levels locat skill$

oode compUanoe consk!eriBQ applicable local. intematiooat regvlatoiY and corporate codes ri&k management and safety review, including:

materials of construction

H;ghly Proteaoel Rlsl< (HPR) deslg" strategies fire and explos!on risks

na1ural hazards security ergonomic tevi9\ll environmental review

tSPE Good P"'Ciioo Guide: Good Engineering PrtcUct

Page 21

abil\y 10 be maintained (e.g .. ae<ess and

•pace.

mate<lal handling)

review IO< oCilky 10 be oomrMsioned (e.g., nushlng polob, odjuolmont and meosuring accessibility)

Sub-Pract.lce 3: DosJgn Rov1ew Mectlanjsm

Regulated comi)8C'llee shoukt define methods ot reviewing the pro:teet d&1ign aceordlng to typo, scale, and risk,

using aultabfy sk.illtid paopte, Including users. to chal~ge the design and cnsuto that specified requirements are delllll>red.

The methods shoukS li:Sontify all relevant codas, regu!a-tioos, technical norms. and standards that may require

compiance. and formally c:onflrm G;pplicabiity and oonb'mance.

Regulated companiH &hotJid ..,.um1hat the . - , indudel ol hlcloro Wk8ly 10 be s;gnfficant ai a given -Slogs.

Sub.flracdco 4: Dea~n Reviow Outcome

Regulated companlaa aho<Jid have appropriaie melhoclo

to<

rOCO«llng and dl...,m;notiog lhe results of design

reviewl, and monoglng any c.oos.equent changes.

The results thou!d confirm Ule oontinuing suitability of lhe design,

3.2.

7

Con

s

truction

Sub.Practlco 1: Ma~WV•ment Sys-tems

R~

....,_.;o.

should have- , _ ol mi8wlog tho options IO< tho consmocfion...,.... slnl1egy

-

to

lis l)'po. ocalo. and risk.

rOQOrting of pcogtMS and lssoos

man.egement of Items construc(ed offsile

the intottaee between the supplier's quality mc:megement syslem ond lhe organiz.atlon's Internal Quality Monagomonl System (QMS), e.g .. the application ol project chonge control vorsus site change control

alte ph~tcel aocon to pWlt and mooagement of per~JQnnel, whllo working on the organiZ{'tion's facl!ily.

Page 22

_ . _ ping and~

""'""''Jon

ond """""""' ol m e l h o d -pundllioting ond ~flnitlon ol completion handovor for commissioning

manogemen

t

of

subcontractors

contractor training

Subol'racllco 2: Quality Standards

ISPE Good Prat.1ic0 Guld&' Good Engineering Praclloo

Regula&ed compotlles should en!Ure adequate means of defining and achieVIng quality standard$.

Qua1ity .,..,_mont oystems should Include:

- ond

IIPil"'V"' of

samples

moano of d<lftnlng quaity standards. e.g .. ccnS!ruCtiOo of ..-nplo rooms

mooagoment of ma1erists. and equipment delivered to sle

construClion quellty control- maintaining cleanliness of ductwork. pt>ewotk. lnlBf stage inspectionstprojeCC hOkl points

consltucllon qualily teals

documentation standard$ and delivefY of oonstruction rocords

Sub-Practice 3: Construction Execution

,

.

Otf..ai.t& and lite pradioe$ thcxll<l be developed basod upon 1 pr1gmatic 1uenme.nt of relevant klcaf ptaetic::es to - ptOjed objocliwl.

3.2.8 Non-GxP R"flulalion Compliance

The regulolld company-haw a mechani~ I« icfent~¥ng and ensuring compliance With all rele\lanl S!atuiOty end rogulatoly ~uifemenn"'> a_chlevo complllnl c:onstJUc:don. - ·

Sub.P,..c-tlct 1: Non..Ox:P Statutory and Regulatory Requlrtmonta Comptiance

Pro;eet procedures should &.nsure responsibility

ts

assigned r

or

ronn811dentl11catlon and enforcem&nt of relevant non-GxP at&tutory and regulatory codes anef t&gulations {or obtaining veri.ancos and waivers). Tills may apply to slto bssad conetrvotioo practices, oonstn.Jctlon tesls and r'ecotds, es well as the specification of &quipmenl (e.g .• pressure

ISPE Good Practice Guide: GoOd ~lng

"'"";oe

Page 23

Sub.Practlcc 2: Constructior; ~ermitting

R~uirement& fOf vatious petmUs required to construct, occupy, and approve desJg.ns should be determined and responsibililia>s dearly assign&d

to

obtain the appropriate permits.

Sub.PracUce 3: Construction Records

Th6 specific k>cal regulatory requiremantslor formal racords should be deftned, and resjX)(lslbility for creating, updating. and filin.g lha records requlfed be deafly assigned.

For an example of a document certifying electrical comp6etion refer to AttaChment K. 3.2.9 Commissioning and Qualification

"::: .. :J"""''' ~" .;· . ...-. --.; _-_-.'. 7 ' · ' - · 0 . , , -• • : • · . ' . ' • .--.·-7·;..-,.~,

'·':

N-0~ < :;;~-'- .-:; ' '--:~ 0 • ~--,,,·~··· . - _ , _ . . . . · . : . · ' + ' -.i. ' •: ·:-·;,.•-;:.-: .:

,

·

the

'

,.eg

·

v

t

a

t

ed

OOinPsto5':~gl,lld hi:IV~· a. system· to en:s.ure

.s

a

tisf

a

t!_6

rt c;ommiss

ioli.ing--afld .qualifiea.t!onlverlflqatlon

f:

f

Qr

p

ro}ects

.

;

f()(

a

n

·exa~

Of

ta.Cmw.·

oonlmissk>ri.ing-guidat.Oe

rere

r

to Auachment'L:::-'·" :":· N • • . ; • _;~: . , ' ·;.~. • f:~-....~.:.-

·

,_.

.

.

,:·:;::,., ..

·

-;,.

. .

.

;.. ;_

.

.

-· ··';..

..

'

...

:,

·.

.

.

;- ...

Sub~Practice 1: System Definition

Regulated comparOOs should have established melttods fOf defining systems and sub systems to be used in commissioning and qualification. These should be k:lgical sub-divisions and wherever pOS$!ble ctlv'do systoms Into GxP and non-GxP to redoce the G.xP qualfficatlon effort.

For an example of strategies for defining $y&:tem boundaries effectfvely refer to Attachment N .. Sub..Practic& 2: Sys.tom RJsk Assessment

Regulated companies shook:! have established methods fOf risk assessment o

r

systems and determlo!ng the level of risk to product quality and patient safely.

Sub~Practice 3: Commi!~sfoning

Regulated -companies shoukl have systems to ensure tt\et effeotive oommiasioning is performed and appropriatety doc\lmented. particulariy where it relales to high risk systems. Comr'ni9sioning should be teferooced to user

requiremeols and testing ehoukl verify that the requirements have. be&n met. The commissioning team sttoutd have$ means of procuring: oonsumables, managing maintonanoo and ca!ibral!on roquirei'I'IGnts. and maintaining operational

logs during the startup to handover petlod. :·

For examples of commmioning plans refer to Attachments 0 and P. Sub·Pra<:llce 4: QuaJiflcation/Verification

Regulated companies shoiJld have a method of risk assessment to ensure that an appropriate degree of qualificallon Is carried out baSad on Identified CriticaJ Quality Attributes (CQAs) and Critical Process Pera.meters (CPPs). 3.2.10 H8fldover

' ~ ~ufated cOmpany shovtd ~ave a defined •Y.Stem for hand<Wer or tho completed fliojoct to

lhe

.

use<. Sub-Practice 1: Documentation Roqulromants

HandO'Ief to th& user should ifldude documentalion which oonf\rms function. capability tha1 vlill adequat.arty facllitale future wpport, e.g.:

ISPE Goo<l Pr&CIIot Gdde: Good Englneorihg

"""'loo

com~klnlog reports. initial operating and maintenance record$ spore parts and operating and molntooanco man~procedute:~ data for entry into relevant molntonance/callbreUoo systems

appropriate training and associated documentation

Tl>e ptojed shoUd be &Miized and adequate roc:o<ds issued (to ll'OYid• a

*""'

ollhe 'as builf slaws) ollho

tyotom.

Sub·PraetJce 2: Standard Opeflltfng and Othor Procodures

Regulated compan~s shoUld prl)poro polrc:y, strategy. Standard Operating Proooduro& (SOPs).. planood maintenance

procecswes, a.~d other plans. as necesta(}', reQuired to operate and molntaln 11\o sytstom. Operators and malnten1nco

pei'IOnnot choold be trained on the ayatem J)fior to handOver. Sub.Practlce 3: Staged Handover

l.afVO

0<-

Cltical ptojedo mt<y )Jtllfy a Slaged "'""""" ol oyo!omt. Where thio lC 1ha case 1ha melhodology

end-

o1 ~ shoiAd be c1e00y defined. D<Mations ("'""""""' and

Pl"1d>

ist iteml) wlli<h roqulre

Ntlhot loliow-<JP action in soibs&qloent ·~ ll\ould be

dearlY

doa.wnontod In ._,."' """"'• oonlin.lily.

3.3

Common

P

rac

ti

ces

3.3.1 Standards and Procedures

~:c·-~· :· . • ·r ,.c .. :~ -.. .. , -· . ~ _-•. "-:'"' • . •

'TM rogula:ed ~pany should have wriUen standards and.prooedures for e• key e6f)eds.of_,_~atb•. T'hl$

st>ould Include .~pt<><)ess ror·~klng ond opptO'V!il!i~ISs!li!)g·and retrieving 118ndard$

and

~ures.

-

--

-

-,

.

Slandorda and

.,.oceo..-.s

should ma ntoinod curenl and efledive.lhey tho<JICI ba reW:wed and

IJilllfOII9d

by opptOptlate potSOtl!ld.

There sho!Ad be a system for Issue of new IUindatds and procedures 1nd for the retrieval of superseded saaooarde and prooedures.

Sub.Practico 2: Structure

A slructure sho\lkl be in plaoe to define thD drfferance be."Yo-een guidance and work instruc.oons.

Wo"<

Instructions

ISPe Good Proalco G\Jiclo: Gt>Od Engln~ Pfactloa

3.3

.

2

DocurrNntalion

Pnteoces

•.

Tho regula*' QOmpolly_sh<iuJd.l>o~~~tsystom•.l<>r !he

g

enera\filrl, reviow.

opproval, Nltleval, and.-llrciJ)}Ilng

01

.

,

wntlon

otandards •. prc~u.~.

!1(ld

rteO<cls, whothor

pa!"'!:-l>a

s

!l,d or electronic.

Tho

oys

tem

:

sllQ<Jd have me(hodo

to erillJ"' the. s.eo;ct'lty.and, Integrity or docume<~ts, _d.,...,lij9. oii.too ·~~~ lmpottar•~,.

of

th~;;e:ljilti> @·legal, , ~•f1lltl91''8l, 0t p«:~t~lonal petSpeclivft. EnginEHtrinO dOctim,ejJts should

1>0

gontrated and main~inSd in a manner

to

onsu

r

O

l

h

atlnformaiiOfi

OOhfaiotd

thMein it'

aecuroie, C

liiai-

,

·

unam

·

biguoua,

ond

Curren

t

:

·

· ·

'

·

:.•.

.

.

-. ··...

.

\·. ;,,

Sub.Pr•ctlce 1: Stora.ge

The eyaloms sllould - . , rapOI ....,.. to ooples and data to appropria10 slaW The syoaomo

<too

shou!<l . . . . _

ICOOfding to ! h e -inv<l~Yed. the .-11, dottruc:Uon,

or-

o1 001dlltod lnlotmaton.- .

to

key

documontatioo ellould be controlled.

Sub-Ptactlce 2: Enginoering Drawings and Specirteations

Tho system should define the level or eoovrecy roquirod for engineering drawlngA, spoctflcatlons, supprl8f, and third

party

documents

.

'Tho system should derane wtllc::h docunents wtll be maintained as ·as bultt' reoorda, how they will be mail"ltalned as

aocuro1<1 and checl<ad on oomplellon of !he wOO<.

- m a y need l o b e -as 'IMngOocurnenls'ond"-"ly ~ lo r8iled latasteone;epl• ond

_.._

....

The uae of 1'\And 'marbd up• (r&d lined) as~

to

rOOra1t&d documents can bo 8PPfopriate, but sl'!ookl be used In a rneni'M!f consistent with the inherent rilka and limitations. I.e., there ahouk1 be 1 clear understanding of where the

'moator' documents are and a cons:ld&f&tion of the risks of using obsolete documeni.S.

Considerotion should be given to th9 ruchlvtng &nd retention of superseded dOcuments where required. Sub.Practice 3: Test and lnspoction Recorde

Tool and lncpedlon reoords may bo of value •• b<lsot:ne pMormance dato or M oontrac:tual 911idence ol

pel1onnonoo. ~

Regutotad companO!s sl1otJid deilno doa>mentatioo st""""ros 1o """''" roconls ore doer and •noml>igUOU$. Typlcel co~ny dOCumentallon standaros may stipulate, e.g., the fClilowfng:

Wrltton entries should be dear end legible using an lndeliblo medium (e.g., In~) tl\al can be ph<llocopied. Information or data should be aocumtoty recorded In a pr8$Cn'bed end controlkld book. form, sheet. or electronic templato at the time each aedon Is taken or ob5ef'Vation is made.

Compliance ol obsll<Wd condition or sta<utlo p<e-approved spoclflcatlons may be indice!ed by a '0,' 'X,' or olher AIOOgnizablo symbol (I.a., a choddill~ Where symbols ate used I should be cteor

tram

too docoolent what Ulo symbol means. Ccnsicfeno5on of using 'pass' or 1al' lor tes1 resuns shoUld 1><1 gM>n lor key lnformalion. Spaoo on forms lllould be ad0Q0181e lot U1e - onlry of clat8, de. Elcpeded rosUIIs need not 1><1 p<e-prinoed on !he lonn

aatong as IIley ore deatty re-.:.cJ.

Page26 ISPE Good P -<Mde: Good Engineering Pr-.c:lk:o

Temporary f1lliiXW(fs ~ ~ Post_.. notM

«

acrvp pepe~ rT1U$i: no; 10 be UIOd.

Fa< unstebk!l media a copy $h0uld be mode In addition to !ha original rocool (o.g. !11em1al papet print-<>Uts).

RfJOO(ds containing photocop18d lnrormatlon shouk:l referenoe the original source. (Nota. Source of the

pholocopy may be annotated manually.)

All peges and printout$ from instruments or data acqu!sitlotl sys:toms should bo Identified appropriately.

Pages ahould be numbered: the •pg,, x of y"' r1otatiofl is reoommended.

8-

._may be filled in wQh 'N/A.' alosh.

dash

,

"'"''''"

recognizable symbol.~ Is consldef8d not neeessary to int!at or date blanb

RIICOIO a'-ls snoold be slgnod and d8\od by the pe<son peffotrring lho funo1>0n. ~ may not be necesoary to

aign, Initial, and date oaeh entry ff h lo wellldenlffied and oomplote onoo In !he doa.mem.

Dolo supers$ded by a subsequent test or inspecdon (e.g., altar

a: r

epair or correction} may be deleted. The tlnaJ

teCOfd shOuk:J be annotated to indicate if a repair or correction h.as beon made.

Conec:lions

may be made by a slngl• l ne

aoss

out. No initials. dotes, or e>cplonatlons are requited as SOng as an

entry is clear aoo un8mblguous.

Enltlo• ohould not be alenld. oblitara!ed. 0< <Net writlel\. The use ol COIT8Ctlon ftuld, e«red tape.

ecc.

.

•hould

nolbepenM!ed.

It should be p~MTT~issible k> ~ansalbo dala from one form to anolhe< (e.g, pl1nlod !ab<Jiar "'-""""'Y ol manual

on~loo). Tronocribe<i date slloold bt aigned and dated. The dale ol tho octuol daCa slloLJid be lndudod. Oltglnol

data ah&e!s and checlllists Should be •va!tDbiG lor rtM&\v until suCh time thlt the transmitted document has boon accepted and approved.

Changes to approved doc:umonls should require r~approval.

Sub-Prectrc• of: Review and Approv•l of Documents - GenefaJ

Apptovers should be able

to

under.tandlhe rncond and be "'l!Jropftaloly educat.ocf,

trained.

and experienood. They

Should no< be ~roo

to_.,..

~d ll1lir

oompetenoo.

•.

Good.,_

req\lireslhallho mspcnsibihty and

•9nifiGonce

ola g~Wn _.,.at signlllure shoUd also be Slated

(o.g. ~on beha~ of maintenance).

oetegatlon

ot

authority to a deslgr.ee should be sanclloned kl proj9d procedores or documented in a memo,

Review &nd approval of a major documont (e.g., specification. report. or drawing) normalty requjres full signature and

d81e.lnitlals may be used for review and approval of calculations. data sheets, ond checklists.

Slgnoture and W.tiats of reviewers should be clearty identifiable and documented eCOOfding to proJect procedures

(o.g .. o slgnot .. <!lln~lal$1og).

'5P£ Good Pnlebco Guide: Good t;ngln-Practice

P2ge27

Rogu!ated companies Shoufd h~ye potlcfes for duplicate records, and protection of stOfed original documents.

Projed turnover proceduJes shoukl indicate wflich records and docu.mants vhll be tumed ovet to the operating unit at

the completion of th& project

Sub·PractiCG 6: Oostructlon of Documents

Proeedutes for destruction of documents. should be established t-o eflsuro destruction. where required, at the expiry of the f8tention period of documents.

Sub.PractiC<! 7: Eloctronlc Records

Electronic rocords of GEP documents are pefTlltssib!e aBd not sub;ect to any -specific regulation. R&eords should be controlled in a manner to ensure that they are seouro; a means of reacbng them and of ensoring that ttleir integrity ls maintained. Electronic records should have Lhe same ktvel of control and acoeptability as the equivalent paper

c

ooords.

3.3.3 Chango Management

5:C~~#·~~~.Qe

.Y.:

~!l

t

is

cr

i

ti

~j

k, ~~EP

.

~~

shoold be

d~flned

·

f

~

t.

ch;allg~

ru.anagement vAlich ;are

~c~erj

tq

f ...

~{

t~

..

~·~

-

~

~

~~

;

·

~n<

:(

sta~~

.l

n

-~

8 ~~

!

etp

·

~i:~

.

~~

·

f?r:

exa

·

~l

e

~

llJ;ir'!utes

;

9f

·~e~

t

i

np

s f

~

~~u~I.~So.J~!on

· ~iQow.r.fsk,..ea~y ~~)., U,~~~Qf .a"!om:ull .proc~d!,!Cf.!·'t_\lltfra. templa}e;fP®,!lrt~ ~CI:f:.:ltln9 througf11Mpa~~.~ ·9_ff=!!-'P,S;IO •·.

w~

~~~~:~!~~~~~~

~

~!T,

~;i

£~i

~1

t~~~~~~~-t~~f~1i:~5~w~=ii~~t~:z~~~;t~i~;+:~j:~~~~;:~{~~;,::~)~

;;

:

f.

f..~

·

~;;

~}~

n~6~~:

P[

§i~

ct

·

~UJ.r~~

.

~~

~

Or ~~~

~

~~~~~

s~

-

~

~

~fb;

::

a~

~

ro(p~

t¥.

~~

a

J,

~Pac

t:

qn

.:

r

~r

~?:i

#~~

~

~~~~

~~

:

~Jf

(~i~,~

.

.:~·}·'·'W

···'

·i·':.~~·.:r~,~~~;~-;_~-,:~

-

~:.~,:·:~;

..

:.~7-~,.~·. r·~~:

..

.-. .. ..

,~

..

~-

.

.

.

:•

. eroposed. OhanQOs

to

..

Opetational·asse{s. should bfYasses.Se~ for p;otenti~l impacron ope1a!:ion and malniMOOOG.

~:~

~

:

~n

~

;

:

;~~

~~~t

·

p

~

·

~~~~

:

s ~h~

:~d

_.

speetty

~~r

~t

s

:

aPrK~P

~

I

a

t

e.

~

·

a

.

ssG~

;~

:ris

k

·

(o.g

..

1ik~-~nke·

.. ,. :-·

•

~!llPQnent ~b·~~~i<?oiJ:shQUld ~e

'

sUb

je

'

ct

'

tO.s;rrtpr~ iGvk~w. Wh~&as~mOre

.

co.x

chailge$

illaY·Jequire formal

}

)~~

~

~~2:f#.

::

~

-

r

w

.

~

~

:

a~

f~~

:~~~·=·Xi~~.:o~J,·~~\.::;?}

:·.~~~:.,fi:t

~~~·:'~~~~

.

·

~·~;::~} -~::.::·

..

·

;·.~-~ ~.:·::;

·

·

Sub..Practico 1: Change Roquest

Rogulated oompanie$ shouid have a change mat!agement system to request changes. Usors, maintenance

engineers. vendors. and

bvaifless

owners afe the most tikaty soorooo of change requests. Change requests should be recorded and uniCJuely ktentlfled. A ohange r&quest shoutd briefly state the reasons why the change is required, re:fening to additional doctJmontatton as appropriate to the scale of the change.

Sub-Practice 2: Regulatory A$$0nment

In an environment where both regulated and non-regulated assets am In use the assessment process should define

whether a change has potential GxP impact

Changes with pot&ntial GxP Impact should go thcough a formal (dooomented} process

to

consider the potential

Impact, tho iflteoc!ed purpose. and the work reqoired to implement the change. Appropriate review and appcovaJ with

notification t-o the Quality unit should be included.

For non-.GxP changes the proc;ess may be iess fOfmalized. Sub-Practk:e 3: Project Impact

The system tor project cnallge control should considef the benefits of the change as vtel as the potential impact on scope, cost. and scheduJe. with stakeholder agreement obtained where necessary.

ISPE Good Practice Guide: Good Englneertng Practice

There sholAd be a fom\SI Pr.99MS to communicate the

change

to the stakeholders e.g .• Uset$,

th

e

quality depc~rtment, protect cost control, and senior management

Sub-Practice 4: Operational Impact

ThA chang& management system for existing assets ahoukl be consider potential impact upon operation and on

malntonanoe.

Where the scope or scaJe of a Ghange is signfficant. managillQ the work performed tl\!ough lhc project eng.!neerlng process should be considered.

Sub-Practice 5: Change Plan

The proposed method of implementiog a change request should be defined. The level of detail contained In this plan shouk:l be appropriate to the assessed impact of the cflange.

Sub-PracticG 6: Testing

The W!vel of testing and documentation app(ied to changes shookl be commensurate with the associated risk.

SutrP

r

actf.ce

7: Records and Change Completion

Ally dlanoes tmplemented shou$d be recorded via updates ro appropriate records (e.g., design speclficatM:Jo, drawings. or maintenance procedures), either as suppiOOlcntal data or revisions to oxls.t!ng rGooc'ds.. A concls.& Change hjstory that includes the unique change klentlfler should be lnoorpcwated ln revised records.

The SyStem shoukl provide confirmation that work has been oompleted in a timety manner. So called 'living Oocum~nts,'

whi

ch

need to document current status should be maintained in a similar manner.

Sub-Practice 8: AnJlys.ls

Regulated oompanies $hOUid

esta

bf

is

h

systems to monitor changes, e.g,, by type or Jc>cation, to identify trends and identity potential underlying issues (e.g .• a poorly defined design) whictl may require en alternative approach in order to eliminate the root causa.

Sub.PracUce 9: Audits

Regulated eompant&s should have audit pJocesses. using prearranged extetnaJ or intemaJ auditors, to ensuta that chsnge control procedures are btNng followed. The review period should be commensurate with the associated risk.

f

o

r

further Information see Section 3.4.5 o1 this Guide.

3. 3.4 Innovation and Conllnuous Improvement

t~~··i""'*;~:.. .... :~:_:f '! • ~f":·"'!'.::::-..::"*:!''0:~·'-¥1, • 0 ¥'·":''"' =1' ,.,, .. "; ~ ~ "': \'.;', ~ YO-·."~'"l•':::~c:""-:=':'.''"'..;;" , ''-":'''::" /f.'Ce;i:z':~/_";;;c'-;7'::"7;-:c- ~;

7

~

r

~~

~

a~

~

~

rry

~y

;

~o~

I

C;t

~

·

r

~l

~,-

~;

:&

q~

~

~

·

~

i

Ch

-.

~~~~~

-

~

~·

~~

-

tO

.

h~

1::

a

:

~

i

~e

,t

?

..

l

V,.

~~

~·f

~I~

.;':':-

::-.~

~

~

~,!~~'1Yi~~~~~~~~t8~~

·

~

~~

~~~

-

~·

"*

·

~C~:~~·~\:·

-

.

~.-:·: .::---:·

·

~~~·--:·'<·:::·>;

-.·;:·'.-/:,, .

..

Sub-Practice 1: Benchmarlclng

Regulated compc~nies should be aware of their performance compared vlith s!milar entetprises and 'best In Class.' Benchmari<ing Should oonsider areas such as;

~/

JSPE GoOd Prectfoo Guidet Good Englneeritlg Pracli¢0

Pag~ 29

calibration and malntel\8flce

bullding costs and times equipment utllzation

rnanpov~er and staffing levels

This data shoukf be usad to detarmlne areas for Improvement and define best practices. Best practices should be

u$ed to improve performance.

Sub-Practice 2: Continuous Improvement

Regul3ted companies should have a system for avaluating returns and complaints. Evalvation of Qoo.vn time and time taken for maintananoe and operatlona1 tasks should be included

Regulated companies should-have processes to improve products and processes OOf'ltinuousty.

For

a

n

example of a project management oomp!&l.lon document that seeks to drive continuous improvement refer Co Attacllmenl Q.

Sub-Practice 3: Training and Development

Regulated comcanies shoukf recogn~e the need for, enootm'lga, and raclt:1ate staff tra!nlng and development using cost effective mett'IOd$. VMue rather than cost should bo thO main consideration. This may indude fin&neialsupport or incentives, tOgatMr wfth mk!ase from day

to

day activity subject to review and approval. The membership of

profooslonallnslltutlons and active particfpation in their activitil8s should be encouraged.

Sub-Practice 4: Professional Pathways

Regulated companies should define care0r groVIth paths allowing professional development and encourage successioo planning and personal development to the benefit of the company.

Sub.Ptactloo 5: Staff Retention

Regulated companies ehould appreciate the value of retaining staff and the expertise apptopriate

to

tl'\efr busines-s, and review staff eapabiiiUe$ against requirements to ensuto best fit. adjusting the structure where neees;Saf)'.

Benchmark.ing to ensure renul'nQI'atJon and tenns are aligned wltn local and industry norms should be performed. Sub.Practice 6: Position Requirements

Regulated companies should be aware of profes-sionaJ qualificatiOns required for tndMdual positions. These shlxlkl be avaiable as part of job descrlplioos/role profiles.

3.3.5 Calibration

; · ... ;;c' ·:, • :•."-".''X' -.~;.;.e-::-~·~~:. ~,., ~ .. ~:·~ >'='· .. ~ . ;~ ... ~ .• :. :"fO.'.: •.-: .. v·::-•v.--•·,.- ., • • • ;.:•~;·," .•·:_,.-·,•: ' ; .~ ~Th~:~gu~t~d ,cor:t.P~~.Y.~~Id h.~ve a.system ~ ensure'Jt'lat all in.sfQJ~ts are man~ge<j. ~o.guara~tee.lfi~t .. tf\ey.'

·are .. maintainedJn a· stat.e Qf-c~lilratio{l. aJ)p(QPrti:fe leN~ _f~ to· pr'riatJ~tqu$!1ty aM ~sln~ss succeSs;· see.~ ' I~P.I?GAMP" GoodJ>raC!

_.

_.

i~ Gujde: .Calibralicin Manogernenl

{see Rereie!

'"" 5, Appendix 3,) .. ,_;

',y • · ,. ·'

Pa~30

Sub-Practice 1: Instrument Selection and Assessment

ISPE Good Pt:JCUOO GviCI«

Good Engineering Praetioo

All instruments shoukJ have a e!eafly defined function in particular whe1her the data output ts used to support product

qua:!ity. Each instrument shou!d be asse&sAd by IM appropriate staff before being put into service, to detennine their

potential to affect produC1. qua!!ty and productlvlty (tlsk). and the risk of instrument uncertainty increasing with time (nood for caJlbratlon). This data should be used to determine:

the selection of the type of instrument used for the awueaUon

the initial frequency of calibration and periodic review agaJnst pcrlormance the tnsttument category, e.g., prtXIuct. process. EHS, or non-critical the cal:lbfation range a.nd accuracy required

Sub.PracUc& 2: lnttrument Schedul& and Recordt

An accurate record should be maintained- of instruments entered into the calibration program. The process f&q\.drements. calibration activity, and any adjustment required ror an Instrument should be recorded. Sub-Practice 3: Calibration Rocord Rovlow

Reootds shook! be securoly stored, retained for a defined period and evai~~eted periocJlcally to cmswe thallhe approl)fiale instrumentation is in use and is routinely calibrated at the a.pprCJPfiate frequency.

Sub.Practic:e 4: Cost Control

Data from Lhe calibratlon management system sh-ould be periodically reviewed to determlne the oost of calibraUon acoordtng to instrument category.

Sub-Practice 5: Pertormanc:e revH!w

Data from calilratiOn actlvflj~ shookl be Mviewed to aS$8$$ trends and drift. These should be used to determine the fre.que-ncy of catlbrallon instrument typ& raqulred to maintain the desired aCQ.Iracy at an aooeptable tevel of risk.

3.3.6 Asset Management

.

~

m

a~g~r

yu~~i'

i

nc.

l

~~

~

th~

·

..aQui

.~~ni

for

do

~~

rne

n

ting

•. m.ar.aging.

·

~

d

.traddng

the

.

r

i

f

e

..

~~;

of

·

assetS.

.

-

.

.

'. '

Sub-Practice 1: Ass~n Register

Asset registers may exist fOf a number of purposes: regulatory requirements

financial aeoounling (e.g., auditing depre-clallon or general ledge-r enttles) r11e and record keeplng organization at~d Identification tagging

security and ownership verification maintenance

lSP£ Good Prac(ioe Guide: Good ~ring Pr.>etico

Page 31

soft aSSG-ts vetsus tlard ass::ts

Financial

etsset

reg;st&rs are requJred

rOt

accounting purposes., dapreci.ation, and security. Asset regis.tet and asset 1egister tags are useful iden!HicatiOO tools to facilitate thi$.

Equipment and tag numbering systems may exist for oUler purposes. e.g .• identifying proce$$ elements for calibration or maintenance. The numbering system $hovld indicete function as well as locatiOn.

Prior to equipment and faeilitie$ being used, they shOoukl be assossGd and lnventOf'ied on an asset register reoordlng usage arld value. This data can b& used to make informed forward planning assessments and ROI decisions. This registercoukllink with other components (e.g .. maintenance and breakdown cost, calibration, procklctivity dGtil, preventative maintenance. or spBJes) so

that

ROI reporting can be performed fOf major equipment and systems.

Sub.Practice 2: Strategy and Planning

Major systems should have maintenance and StJppori strategies as well as plans and procedl!fes for future enhancements and upgr&OOs. Evaluation tools such as Reliability Centered M,aintenanoe (RCM), Failure Mode end ElfectAnalysis (FMEA). and Root Cause Analysis (RCA) sllould be OOflSidere<J.

Sub .Practice 3: Support

Systems and equipment should have defined, documented support procedures. whether st~pport is performed in-house or \fia system supplier or third -party support.

Sub-Practice 4: Computer Systems

PriOf to a computer system or software package being used, it sholM' be assessed and recorded on an asset regrster or systems register to record fts usage and status. Where a system is used for G>CP as v~ll as GEP purposes then this fact should be recorded on the register.

3.3.7 Vendor/Supplier ManBgement

<''--> ,,. ... ,,, .... ,~ .. :'~-!,- _., .·-;-_:"·-.::--.:·:·•.'/ . . . . ··:---.. · ;•, '·'·-·· • • •• • ·- .•.• ;,, • • . • ·•,:

~1':'~.ocumc~-~· prOoeS:S_ 9f·.sVPP.lJ~!..f!:i~.l'!a~~~.nt s~l~:~ in.e&a~;t~ en~re that suw.lie< .faclli~:Pfa_?ices and.'.·-!

~

stand3rd

~

~

pr

e

~

,all

"

~~f

.

!

.

~

.. .

r.

~~

.

~

.

:

...

}

.

he

·

..

;·,

f

.

~

egUi

a

t

a

'ifoom

...

"-··.

Pii?Y

.,

z:~

..

_~-:-:.~--.:·~·:.:1<~'-;i;

'-•..:tj";"-·'~.;.;,~:;

:/: .

.:

.

·

·

·

...

-

.. ·'-""·--

..

..

.

-. ,.,...-

...

,_.___

.

.

Sub-Practice 1: SuppUer Management

Regulated compa~~les should have systems for contlnu-lr.g research and accreditation of suppliers of services and materials, ensuting adequato quality standards are ma!ntalnsd, with core suppliers and a backo.Up strategy.

Sub-Practice 2: Supplier Audk Plan

An audit plan should be established to cowr the rout ina audit of k.ey external suppliers.

Use-$hould be made of supplie-r' audit check l!sts to ensure consrs.tency. These may be used for trood data.

f<X an &)(ample of an audit template and a postal quality audit refer to Attachments Rand S.

3.3.8 Engineering Storage

.The -regulated company has a system .ensuring that .appropriate storage sys!Oil'r$ axisf.to ensure adequate i

e

·

ng

·

i

ne61jn9

spSI'E}$·, iOO.s

,

equip,rOant,

and ftla1Gt

1

9

t

s

.are ·available tO be supp;li&d

to

the b'uslrJeSS in a timely

inanner.:;:.:J:-: _· • ... : · · • · ,, .-· · .',.. · · . '·.'. · - ·

-Page 32 ISPE Good Prxuc. Guf<b: Good Engi'leering Practice

Sub-Practice 1: FaciUties

Regulated companies shoukl hsYe established central or local storage with suitable security, e-nvironmental

conditions. storage, and retrieval systems

to r1'\lRltai

n and deliver items in an undam.:Jgod state.

Sub··Practice 2: Inspection

R.eguJated companies shoukl haV'e systems to inspecC goods reoeived against agreed speclfleatfons.

Sub-Prac:tlce 3: Inventory Control

Regulated companies shou1d manage stores inventOOes to ensure adequate stocks for envisaged reqliiremo:nts, and manage the foUowi:ng activities to yield best va!oe:

purchasing {e.g. .. Ofder quantities, delivery times, storage cost$)

slotago (First In First Out (FIFO)/ Fi<$1 Expired Flr<l Out (FEFO) If appropriate)

sub

con

tract

supply and

storage

Sub.Prnctice 4: Identification

Regulated oompan:es should have systems to correctly Identify and label spares, materials, tools, test equipment

~nd change parts. This may be part of an overall asset management system.

Sub.PracUce 5: Cleaning

Regulated oompanies should have established approptiate procedures f()( decontamination and treaning of change parts, materials, tools, and calibration equiptnent to prevent cross contamination by engineering activities.

Su.b.Practice

6: Project Storage

Where neoessary, regulated oompanies should create separat(;t set down areas 0( S-lo(a.g& \IMh the assoolated procedures required for project equipment not part ol routino operations.

3.4

Operations and Maintenance

3

.

.

4.1

Documentation

~~

Q~tjgri

~~

;;s;M;

'f

rrte

·

;

~

c

~

-·

~~

i

~

·

~

·

i

~Q~r4

~

~

·

~

:·

~

P~

~A:J

-

O:dt~tatl~

·

~

~

tO

allo~

:~~ti

ne

actMti~·

to

be;'~·;;;/:>

.... .... '"{f' ••••• : ":';. ;: ... - - ·-~~_, ~ •"""-·" • • • •· •• • ' ... , , .• ••• ·, • • .. . . -·.;·..- •• ,•. ·.: <;:~oiine:'!_Q9~s.tentl)' and Ita~,

tl

je

).j~!OJX

'\f

~~·~~··).S~Illl?.rli"il "?"'Jiil~g!a1\0flisboo1cl ·~~Y,.!\"~"1;st&H

to" ,

[

~~l

~

~

~

;

~

~

~!~

:tk

-I~it~~~~~.;~:~~rq:?~

.

i~#~~~t~~Yt-:re.;~H~;;~~i~~~:·~J~~~:nt~~~~;~~E}~ti.i~f-~,:,~f~~·~-~

Sub-Practic

e1:

Procedu(OS

Operation and maintenance activities should have written procedures to ensure that actl~ are repeatedly performed ag-ains.t an approved method. Prooedures sl1ou!d fOllow thO pcactlc& defined in equipment manuals. The

level of detail should allow appropriately quc'IJified and tmlnod staff to undefsland the actions required. Sub·Practic& 2: RKOrds

Operation and engineering records should be maintained. Records should ba kept current

!

O

maintain a state of compliance and approvaL Procedures shoukS a!low the use of red lin& matte ups with poAodlc updlltes for maintenance reference purposes.

tSPE Good P~ Guide. Good Etlglnoo!lng Pr..,t;co

Sub..PraetJee 3: Record Availability

E.nglnooring f9COI'ds Shedd be readily aval&ble

to

support statr and roullnely Inspected for accuracy, completeness.

3.4.2 Englnooring Manuals and Records

A roguloted oompany shook! ha"" a dolned molhod of crea1ing and malntolnl!lg englnoering manuals and records relll\l11g 1o ra.iilies. equipment. and product$.

Sub-PractJce 1: Assessment and Revtew

Rego • .,.., com;>a11ies sho<;ld ho~ mo1hcdo lot d<tte<miniolg wt;ch - "'" noqulrod. and 1lle nm1 eifec:Vve format f-ew storing and maintain.ng those

recxwdl.

Records should be revieWed b)' staff ac::cording

to

th& level ot risk irW<llvod.

Sub.PractJco 2~ Maintenance of Recorda

Sys·tems shouki be established to ensure that stofBd reootds are current, and l:s6uod on request. with obsolete vetslons of ~r1ier releases retainod and luuod only when specifically r&quested. There should be a system for ver$Jon control with hl&ory.

S<Jb-Proctic<t l: Revlslon Concrol

Thoro ahould be on eslall6sllod syo~em 10 no4ofy potSOOOel who need to " ' -ol any changes lo a specilic reconl wt11ch may be in their posses!;iOn.. RGcrieYal or destruction of Stlperseded documents sfloUd be a part or this system. Sub-Practice 4: Aecos.s

Englnooriog manuals should be reed~y evfdlablct to maintenance persoonel. Consldorallon shOOkt be given to s\orage of manus!~ adjacent to relevant equlpmenl. This should be balanced egain:st tho nood to control too documents and keep them oomplele, acx::urata and current.

3.4.3 Roullne Maintenance

-lvo

-

(PM)p!O¥!clos

-and

procedures formutine ac:tiVIIioo sud> as~.

c!N~Wlg. modifyW!g. mointaining. and~ O<JJipmen\ 10 assure c:cnlinuod performance, In aoooldanco

wah specilications. OperaOOns end rnlllr\Wnanoo methods and resourcesli'8 arrangod to maxkni:ze business ber\orots. mnrrize the consequences

or

fllnctlonal faiure to p<oduct and buolness actlvflies, and deliver tha quanty a&suranee espects

ot.

the process to ar1 organization.

Sub-Practice 1: Aues.smcnt

EQUipment should be assessed for polontlol fallur9 modes before being put !Mo produetlvo u!lo to determif!o the potential &o affect prodll(:l, quality and pfOCiuctlvlty. Risk assessments should be u * Lo dot«mine the initial frequency

ot

ma.ntenance for feilure mitigation, and should be periodically reviewed a.ga1nSilho res.tits obmined.

Sub.Prac:tlc:e 2: Maintsnance Interval

The maintenance inle<Yal shcMd take Into aoc:oun1 manuladur.,. reoornmanoaoono. ""' u&e<'s experiooce with tho typo of O<julpmerl. and its inherot~t dMlgn. Typically. O<juipment v.ill have some m""'IQ<lanc:e t1s1< based crilicalfty

lovel a .. lgne<l basad oo EHS. GxP, p<oduct Impact "'operational criliC8Ii\y. Molntonanoo should be perlormad aga$nst manufacturer's prooed!Kes mocUtiQd on the basis cf experience and user requltemerlts. Data review and chango management raDrxlale shOukl be used to adjust maintenance intervalS-.