EN 61512-4:2010

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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).
__________
- 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

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
– 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

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

– 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

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

– 6 – 61512-4 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
BATCH CONTROL –
Part 4: Batch production records

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61512-4 has been prepared by subcommittee 65A: System
aspects, of IEC technical committee 65: Industrial-process measurement, control and
automation.
This standard cancels and replaces the IEC/PAS 61512-4 published in 2007. This first edition
constitutes a technical revision.
The text of this standard is based on the following documents:
FDIS Report on voting
65A/537/FDIS 65A/546/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.

61512-4 © IEC:2009 – 7 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
A list of all parts of the IEC 61512 series, published under the general title Batch control, can
be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

– 8 – 61512-4 © IEC:2009
INTRODUCTION
IEC 61512-1 provides models and terminology applicable to batch control. Subclause 5.5
defines product information concepts, and subclause 6.4 defines production information
management activities and functions.
Clause 4 of IEC 61512-2 provides an object model of production information, and Clause 5
defines batch history exchange tables. The batch history exchange tables given in Clause 5
are one implementation for production information.
Whereas IEC 61512-1 and IEC 61512-2 provide significant information concerning batch
history and production information, they are not sufficient for use as standards for
implementing specific technologies and are lacking in scope and content.
This part of IEC 61512 provides a detailed definition for batch production records. It consists
of a description and object model of batch production record contents.
The intended use of this batch production record standard is to provide a reference model for
developing applications for the storage and/or exchange of batch production records.
Implementations based upon this standard will allow retrieval, analysis, and reporting of
selected batch production record data.
This batch production record standard is compliant with the batch data model in Clause 4 of
IEC 61512-2, as well as with IEC 61512-1.
Although this standard is intended primarily for batch processes, it may be of considerable
value for other types of processes.

61512-4 © IEC:2009 – 9 –
BATCH CONTROL –
Part 4: Batch production records

1 Scope
This part of the IEC 61512 series defines a reference model for batch production records
containing information about production of batches or elements of batch production. This
standard is intended for batch processes.
2 Normative references
The following referenced documents are indispensable for the application of this document.
For dated reference, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
IEC 61512-1:1997, Batch Control – Part 1: Models and terminology
IEC 61512-2:2001, Batch Control – Part 2: Data structures and guidelines for language
ANSI/ISA-95.00.01:2000, Enterprise-Control System Integration – Part 1: Models and
Terminology
ANSI/ISA-95.00.02:2001, Enterprise-Control System Integration – Part 2: Object Model
Attributes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE Terms and definitions given in IEC 61512-1 also apply, except where differences are explicitly stated in
this part.
3.1
batch history
all execution information collected pertaining to the production of a single batch, and may
include common (non-batch specific) information
3.2
batch production record
subset of the execution and business information that is retained based upon business
requirements identified by the batch production record specification
NOTE This information could include the recipe procedural element execution information, both specific
equipment information, operator comments, batch-related alarms, elements related to the definition of a batch
(such as control recipe, master recipe, site and/or general recipe, batch schedule information), and information
important to the batch (such as training logs, maintenance records, and environmental conditions).
3.3
batch production record report
extraction of information from one or more batch production records that is formatted for
printing, displaying, or sending to a collaborating system

– 10 – 61512-4 © IEC:2009
3.4
batch production record specification
definition of the requirements of execution business information used for generation of a
batch production record or the data to include in the batch production record and specification
if data is to be referenced or extracted
NOTE This information could include the contents, calculations, and other rules needed to identify the pertinent
information.
3.5
batch production information
execution information that is recorded during the course of batch production and the business
information relating to batch production
NOTE Batch production information can be batch specific or it can be common to several batches.
4 Batch production record description
4.1 General
This clause provides an informative overview of a batch production record as defined in
Clause 5 of this standard. This document defines a standard reference model for batch
production records. A batch production record contains batch production information and
related business information. A batch production record is created to meet a business
requirement, and the contents of a batch production record are determined by the business
requirement.
EXAMPLE
A batch production record might be created to document:
– production of a batch;
– storage and handling of a material lot or sublot;
– production-related activities of a person or group of persons or of a piece of equipment or set of equipment.
NOTE 1 IEC 61512-1 and IEC 61512-2 define production information and batch history functions, provide lists of
the types of data they encompass and provide abstract models. However, IEC 61512-1 and IEC 61512-2 do not
define a formal and precise model of production information and batch history data. This part of IEC 61512 does
not further define these terms and does not define production information or batch history system functions.
This part of IEC 61512 defines an object model, object attributes, and relationships between
object instances that can be used to implement data structures used for the exchange of a
subset of a production information and batch history data. The object model is called a batch
production record. This standard is intended to be used as a reference model for the creation
of technology-specific specifications for the data that make up batch production records.
Batch production may require the involvement of multiple control systems, related computer
systems, and manual actions. Therefore, it is possible that the information making up batch
production information may be distributed among multiple computer systems and also contain
components in paper form.
NOTE 2 “Production” implies batch production in all cases unless otherwise stated.
Standardization of batch production records is intended to enable development of solutions
that support specific interfaces and repositories that can be used and supported by multiple
operating companies and vendors. The existence of a batch production record standard may
also enable improved communication within a single company, between different companies,
and between companies and government or regulatory agencies.
Figure 1 illustrates data flows associated with creating, maintaining, and using a batch
production record. Of these functions and data items, only the batch production record is

61512-4 © IEC:2009 – 11 –
defined in this standard. The other functions and data items are shown to illustrate the
environment batch production records are used in. Not all sources of data, functions
performed on or uses of batch production records are illustrated in this figure.

General/site recipe,
training data, certificates of
Batch production records may reference or
analysis, safety, etc. include data from other, existing, batch
production records
EExxisistintingg B baatctch h
Batch production
Proprodducucttiioonn
Batch production
record
Rerecocord(rd(ss) )
record report
create/update
request create request(s)
Business
Batch
information Batch production records contain
references or extracted data from
production
execution and business information
record report
(information
Create/update Create batch
BatcBatch h
formatted for
batch production production
Proprodducucttiioonn
printing or
record(s) record report(s)
Rerecocord(rd(ss))
displaying)
Production
Provides data references or captures
One or more
execution extracted data from batch execution
reports may be
Batch production
and batch business information for data
information
created from
record report
as required in the batch production
batch production
specification
record specification or business rules
records (a report
may contain
Defines the format and data to
information from
include in the batch production
multiple batch
Batch production
report
production
Data from production,
record
records)
master/control recipe, the
specification
Defines what data to include in the
batch execution definition, batch
production record and may specify if data
production history, and the
is to be referenced or extracted
processing environment
IEC  2003/09
Figure 1 – Batch production record creation and use
4.2 Overview
4.2.1 Batch production record
A batch production record is a subset of the production execution and business information
that is retained based upon pre-defined business requirements identified by the batch
production record specification. The structure of the batch production record is based on the
logical object model defined in Clause 5.
A batch production record consists of data about the manufacture of the product plus all
supporting data required to meet the business requirements of the record. The data may
come from multiple sources and may be either extracted (captured into the record) or
referenced in the source system.
EXAMPLE 1 The business need could be a record of production quality.
EXAMPLE 2 The business need could be a record of equipment maintenance such as cleaning or sterilization.
Each batch production record is created to satisfy the specific business requirements as defined by a unique batch
production record specification.
EXAMPLE 3 The system could create a batch production record for the operational execution of an element of
batch production.
EXAMPLE 4 The system could create a batch production record for the personnel efficiency of an element of batch
production.
An element of batch production might be a batch, lot, campaign or other batch activity such as
pre-weigh.
– 12 – 61512-4 © IEC:2009
A batch production record can reference other batch production records.
EXAMPLE 5 A batch production record can reference the records for intermediate materials.
EXAMPLE 6 A batch production record can include the records received with purchased ingredients.
EXAMPLE 7 A batch production record can be the union of all batch production records for all processing segments
that create a final product.
Individual batch production records can be combined into a larger batch production record.
Multiple batch production records can be created for a single element of production.
Multiple batch production records can contain the same and/or mutually exclusive data.
EXAMPLE 8 A control system can create a batch production record for the execution of an element of batch
production and an MES (Manufacturing Execution System)/ERP (Enterprise Resource Planning) system can create
another batch production record for the same element of batch production that includes some of the same data
included in the control system record and additional data known only to the MES/ERP system.
A key factor that differentiates batch production records from traditional time-based plant
history records is that batch production records are stored and retrieved on an element of
batch production basis, such as on batch basis or on a control recipe’s unit procedure,
operation or phase basis.
4.2.2 Business information
Business information is data from non-production business systems.
EXAMPLE Business information might include material, training or safety data.
4.2.3 Production execution information
Production execution information is data about production resources (equipment, materials,
and personnel), recipe execution, and information from the processing environment.
EXAMPLE 1 Production execution information might include equipment status, material consumption, the definition
of production rules, or production history.
EXAMPLE 2 Production execution information might include environmental monitoring, utilities status or other
information on the processing environment.
4.2.4 Batch production record specification
A batch production record specification is the information that is intended to be used to define
a batch production record. The content and format for batch production record specifications
are not defined in this part of IEC 61512.
There can be any number of batch production record specifications per element of batch
production.
Each batch production record is based upon a single batch production record specification.
The same batch production record specification may be used to produce batch production
records for multiple batches, multiple executions of similar elements of batch production,
different material lots/sublots, equipment or personnel use.
EXAMP
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