1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBatch controlPart 4: Batch production recordsBS EN 61512-4:2010National forewordThis British Standard is the UK implementation of EN 61512-4:2010. It isidentical to IEC 61512-4:2
2、009. It supersedes DD IEC/PAS 61512-4:2007 whichis withdrawn.The UK participation in its preparation was entrusted by Technical CommitteeGEL/65, Measurement and control, to Subcommittee GEL/65/1, System considerations.A list of organizations represented on this committee can be obtained onrequest to
3、 its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2010 ISBN 978 0 580 64460 3 ICS 25.040.40; 35.240.50Compliance with a British Standard cannot confer immunity from legal obligations.This Brit
4、ish Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2010.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 61512-4:2010EUROPEAN STANDARD EN 61512-4 NORME EUROPENNE EUROPISCHE NORM September 2010 CENELEC Europe
5、an Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr 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 CENE
6、LEC members. Ref. No. EN 61512-4:2010 E ICS 25.040.40 English version Batch control - Part 4: Batch production records (IEC 61512-4:2009) Contrle-commande des processus de fabrication par lots - Partie 4: Enregistrements de production par lots (CEI 61512-4:2009) Chargenorientierte Fahrweise - Teil 4
7、: Aufzeichnungen zur Chargenproduktion (IEC 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 wit
8、hout 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 langu
9、age 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 Repu
10、blic, 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. BS EN 61512-4:2010EN 61512-4:2010 - 2 - Forewor
11、d 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 t
12、o 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 public
13、ation of an identical national standard or by endorsement (dop) 2011-06-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2013-09-01 Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 61512-4:2009 was ap
14、proved 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
15、 modified). _ BS 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 editi
16、on 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
17、1997 Batch control - Part 1: Models and terminology EN 61512-1 1999 IEC 61512-2 2001 Batch control - Part 2: Data structures and guidelines for languages EN 61512-2 2002 ANSI/ISA-95.00.01 2000 Enterprise-Control System Integration - Part 1: Models and Terminology - - ANSI/ISA-95.00.02 2001 Enterpris
18、e-Control System Intergration - Part 2: Object Model Attributes - - BS EN 61512-4:2010 2 61512-4 IEC:2009 CONTENTS INTRODUCTION.8 1 Scope.9 2 Normative references .9 3 Terms and definitions .9 4 Batch production record description10 4.1 General .10 4.2 Overview .11 4.2.1 Batch production record.11 4
19、.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 Regu
20、latory compliance 13 4.3.4 Production release 13 4.3.5 Deviation management 14 4.3.6 Quality management14 4.3.7 Material tracking and tracing14 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 Costing14 4.3.12 Production kn
21、owledge base.14 4.4 Batch production record data management15 4.4.1 Data retention15 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 states16 4.5 Batch production record structure16 4.6 Production information 19 4.6.1 Gen
22、eral .19 4.6.2 Business information .20 4.6.3 Production execution information.20 4.6.4 Procedural element data20 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 d
23、ate manifestation26 5.2.2 Language 26 5.2.3 Common (non-batch specific) data 26 BS EN 61512-4:201061512-4 IEC:2009 3 5.2.4 Units of measure .26 5.2.5 Referenced data26 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 identificatio
24、n.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 entry32 5.6 Event 33 5.6.1 Event object 33 5.6.2 Event
25、 attributes .34 5.6.3 Alarm event .35 5.6.4 Standard event type 36 5.6.5 User-defined attribute38 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 specification41 5.7.4 Tag specification .42 5.7.5 Ordered data .43 5.7.6 Data value.43 5.7.7
26、Time value.43 5.8 Comment.44 5.9 Sample44 5.9.1 Sample object44 5.9.2 Sample attributes 45 5.9.3 Sample test .46 5.9.4 Sample test result46 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
27、Production request 50 5.16 Control recipe50 5.16.1 Control recipe object .50 5.16.2 Control recipe attributes 52 5.16.3 Control recipe header52 5.16.4 Equipment requirement .53 5.16.5 Constraint .54 5.16.6 Formula.54 5.16.7 Parameter .55 BS EN 61512-4:2010 4 61512-4 IEC:2009 5.16.8 Parameter value55
28、 5.16.9 Procedure logic .56 5.16.10 Link.56 5.16.11 Step 56 5.16.12 Transition57 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.
29、4 Extending the object model .61 Annex A (informative) Data modelling technique 62 Annex B (informative) Questions and answers .64 Bibliography70 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
30、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 model28 Figure 9 Batch produc
31、tion 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 set40 Figure 16 Sample correla
32、ted 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 model59 Figure 22 Master recipe model.60 Table 1 Batch production record cate
33、gories .22 Table 2 Table example.28 Table 3 Batch production record attributes.31 Table 4 Batch production record entry attributes 32 BS EN 61512-4:201061512-4 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 att
34、ributes 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 T
35、able 17 Sample test attributes46 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
36、 Equipment requirement attributes54 Table 25 Constraint attributes 54 Table 26 Parameter attributes55 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
37、 value attributes58 Table 33 Recipe element attributes59 Table 34 Master recipe attributes.60 Table A.1 UML notation .63 BS EN 61512-4:2010 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
38、 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
39、 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
40、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 record
41、s. 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
42、 primarily for batch processes, it may be of considerable value for other types of processes. BS EN 61512-4:201061512-4 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 ab
43、out 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
44、 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: Mode
45、ls 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
46、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 b
47、usiness 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 c
48、ontrol 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 rec
49、ords that is formatted for printing, displaying, or sending to a collaborating system BS EN 61512-4:2010 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
