SIST EN 61512-4:2010

SLOVENSKI STANDARD
SIST EN 61512-4:2010
01-november-2010
Nadzor šarže - 4. del: Zapisi o posameznih šaržah (IEC 61512-4:2009)
Batch control - Part 4: Batch production records (IEC 61512-4:2009)
Chargenorientierte Fahrweise - Teil 4: Aufzeichnungen zur Chargenproduktion (IEC
61512-4:2009)
Contrôle-commande des processus de fabrication par lots - Partie 4: Enregistrements de
production par lots (CEI 61512-4:2009)
Ta slovenski standard je istoveten z: EN 61512-4:2010
ICS:
25.040.40 Merjenje in krmiljenje Industrial process
industrijskih postopkov measurement and control
35.240.50 Uporabniške rešitve IT v IT applications in industry
industriji
SIST EN 61512-4:2010 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61512-4:2010

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SIST EN 61512-4:2010

EUROPEAN STANDARD
EN 61512-4

NORME EUROPÉENNE
September 2010
EUROPÄISCHE NORM

ICS 25.040.40


English version


Batch control -
Part 4: Batch production records
(IEC 61512-4:2009)


Contrôle-commande des processus  Chargenorientierte Fahrweise -
de fabrication par lots - Teil 4: Aufzeichnungen
Partie 4: Enregistrements de production zur Chargenproduktion
par lots (IEC 61512-4:2009)
(CEI 61512-4:2009)




This European Standard was approved by CENELEC on 2010-09-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels


© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61512-4:2010 E

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SIST EN 61512-4:2010
EN 61512-4:2010 - 2 -
Foreword
The text of document 65A/537/FDIS, future edition 1 of IEC 61512-4, prepared by SC 65A, System
aspects, of IEC TC 65, Industrial-process measurement, control and automation, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 61512-4 on 2010-09-01.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2011-06-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2013-09-01
with the EN have to be withdrawn
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 61512-4:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 61512-3:2008 NOTE  Harmonized as EN 61512-3:2008 (not modified).
IEC 62264-1:2003 NOTE  Harmonized as EN 62264-1:2008 (not modified).
__________

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SIST EN 61512-4:2010
- 3 - EN 61512-4:2010
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Publication Year Title EN/HD Year

IEC 61512-1 1997 Batch control - EN 61512-1 1999
Part 1: Models and terminology


IEC 61512-2 2001 Batch control - EN 61512-2 2002
Part 2: Data structures and guidelines for
languages


ANSI/ISA-95.00.01 2000 Enterprise-Control System Integration - - -
Part 1: Models and Terminology


ANSI/ISA-95.00.02 2001 Enterprise-Control System Intergration - - -
Part 2: Object Model Attributes

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SIST EN 61512-4:2010

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SIST EN 61512-4:2010

IEC 61512-4
®
Edition 1.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside


Batch control –
Part 4: Batch production records

Contrôle-commande des processus de fabrication par lots –
Partie 4: Enregistrements de production par lots

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 25.040.40 ISBN 2-8318-1065-6
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 61512-4:2010
– 2 – 61512-4 © IEC:2009
CONTENTS
FOREWORD.6
INTRODUCTION.8
1 Scope.9
2 Normative references .9
3 Terms and definitions .9
4 Batch production record description.10
4.1 General .10
4.2 Overview .11
4.2.1 Batch production record.11
4.2.2 Business information .12
4.2.3 Production execution information.12
4.2.4 Batch production record specification .12
4.2.5 Batch production record reports.13
4.3 Batch production record purpose.13
4.3.1 General .13
4.3.2 Process and/or production analysis, optimization and reporting .13
4.3.3 Regulatory compliance .13
4.3.4 Production release .13
4.3.5 Deviation management .14
4.3.6 Quality management.14
4.3.7 Material tracking and tracing.14
4.3.8 Equipment tracking and tracing .14
4.3.9 Personnel tracking.14
4.3.10 Complying with contractual requirements.14
4.3.11 Costing.14
4.3.12 Production knowledge base .14
4.4 Batch production record data management.15
4.4.1 Data retention.15
4.4.2 Data integrity.15
4.4.3 Creating batch production records .15
4.4.4 Updating batch production records .16
4.4.5 Lifecycle states.16
4.5 Batch production record structure.16
4.6 Production information .19
4.6.1 General .19
4.6.2 Business information .20
4.6.3 Production execution information.20
4.6.4 Procedural element data.20
4.6.5 Common (non-batch specific) data .21
4.7 Batch production record elements .22
5 Batch production record object model.25
5.1 General .25
5.2 Modelling information .26
5.2.1 Time and date manifestation.26
5.2.2 Language .26
5.2.3 Common (non-batch specific) data .26

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SIST EN 61512-4:2010
61512-4 © IEC:2009 – 3 –
5.2.4 Units of measure .26
5.2.5 Referenced data .26
5.2.6 Modelling techniques.26
5.2.7 Attribute definition .26
5.2.8 Null values .27
5.2.9 Data quality .27
5.2.10 Object identification.27
5.2.11 Data types .27
5.2.12 Procedural element references .27
5.2.13 BPR internal references.28
5.2.14 Definition of examples .28
5.3 Batch production record object model overview .29
5.4 Batch production record .30
5.5 Batch production record entry.32
5.6 Event .33
5.6.1 Event object .33
5.6.2 Event attributes .34
5.6.3 Alarm event .35
5.6.4 Standard event type .36
5.6.5 User-defined attribute.38
5.6.6 Event association .39
5.7 Data set .39
5.7.1 Data set object .39
5.7.2 Data set attributes .41
5.7.3 Time specification.41
5.7.4 Tag specification .42
5.7.5 Ordered data .43
5.7.6 Data value .43
5.7.7 Time value.43
5.8 Comment.44
5.9 Sample.44
5.9.1 Sample object.44
5.9.2 Sample attributes .45
5.9.3 Sample test .46
5.9.4 Sample test result.46
5.10 Change .47
5.11 Personnel identification manifest .48
5.12 Resource qualification manifest.48
5.13 Product definition .49
5.14 Production response .49
5.15 Production request .50
5.16 Control recipe.50
5.16.1 Control recipe object .50
5.16.2 Control recipe attributes .52
5.16.3 Control recipe header.52
5.16.4 Equipment requirement .53
5.16.5 Constraint .54
5.16.6 Formula.54
5.16.7 Parameter .55

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SIST EN 61512-4:2010
– 4 – 61512-4 © IEC:2009
5.16.8 Parameter value.55
5.16.9 Procedure logic .56
5.16.10 Link .56
5.16.11 Step .56
5.16.12 Transition .57
5.16.13 Other information .57
5.16.14 Other information value .58
5.17 Recipe element .58
5.18 Master recipe .59
6 Completeness, compliance and conformance .60
6.1 Completeness .60
6.2 Compliance .61
6.3 Conformance.61
6.4 Extending the object model .61
Annex A (informative) Data modelling technique .62
Annex B (informative) Questions and answers .64
Bibliography.70

Figure 1 – Batch production record creation and use .11
Figure 2 – Batch production record component objects .17
Figure 3 – Example of a batch production record .18
Figure 4 – Example of elements referencing other elements .19
Figure 5 – Example of internal and referenced data .19
Figure 6 – Sample batch production record for a recipe element.21
Figure 7 – Batch production record with non-batch specific data .22
Figure 8 – Object reference model .28
Figure 9 – Batch production record top level model.29
Figure 10 – Batch production record object model .30
Figure 11 – Event model .33
Figure 12 – Example of event element relationships .34
Figure 13 – Data set model.39
Figure 14 – Sample time series data set .40
Figure 15 – Elements of a time series data set.40
Figure 16 – Sample correlated data set.40
Figure 17 – Elements of a correlated data set.41
Figure 18 – Sample model .45
Figure 19 – Control recipe model .51
Figure 20 – Sample batch production record with two control recipe copies .51
Figure 21 – Recipe element model.59
Figure 22 – Master recipe model.60

Table 1 – Batch production record categories .22
Table 2 – Table example.28
Table 3 – Batch production record attributes.31
Table 4 – Batch production record entry attributes .32

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SIST EN 61512-4:2010
61512-4 © IEC:2009 – 5 –
Table 5 – Event attributes .34
Table 6 – Alarm event attributes .35
Table 7 – Standard event types .36
Table 8 – User-defined attribute attributes .38
Table 9 – Event association attributes .39
Table 10 – Data set attributes .41
Table 11 – Time specification attributes .41
Table 12 – Tag identification attributes .42
Table 13 – Data value attributes .43
Table 14 – Time value attributes .44
Table 15 – Comment attributes .44
Table 16 – Sample attributes .45
Table 17 – Sample test attributes.46
Table 18 – Sample test result attributes .46
Table 19 –Change attributes .47
Table 20 – Personnel identification manifest attributes .48
Table 21 – Qualification manifest attributes .49
Table 22 – Control recipe attributes .52
Table 23 – Control recipe header attributes .52
Table 24 – Equipment requirement attributes .54
Table 25 – Constraint attributes .54
Table 26 – Parameter attributes.55
Table 27 – Parameter value attributes .55
Table 28 – Link attributes .56
Table 29 – Step attributes.57
Table 30 – Transition attributes.57
Table 31 – Other information attributes .58
Table 32 – Other information value attributes.58
Table 33 – Recipe element attributes.59
Table 34 – Master recipe attributes.60
Table A.1 – UML notation .63

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SIST EN 61512-4:2010
– 6 – 61512-4 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

BATCH CONTROL –

Part 4: Batch production records



FOREWORD
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