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GB/T 19892.4-2022: Batch control - Part 4: Batch production records
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Batch control - Part 4: Batch production records
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GB/T 19892.4-2022
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Basic data | Standard ID | GB/T 19892.4-2022 (GB/T19892.4-2022) | | Description (Translated English) | Batch control - Part 4: Batch production records | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | N10 | | Classification of International Standard | 25.040 | | Word Count Estimation | 70,782 | | Date of Issue | 2022-10-12 | | Date of Implementation | 2023-05-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 19892.4-2022: Batch control - Part 4: Batch production records---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Batch control - Part 4.Batch production records
ICS 25.040
CCSN10
National Standards of People's Republic of China
Batch control part 4.batch production records
(IEC 61512-4.2009, IDT)
Released on 2022-10-12
2023-05-01 implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface VII
Introduction VIII
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Batch Production Record Instructions 2
4.1 Overview 2
4.2 Overview 3
4.2.1 Batch Production Record 3
4.2.2 Business Information 4
4.2.3 Production Execution Information 4
4.2.4 Batch Production Record Specification 4
4.2.5 Batch Production Record Report 4
4.3 Purpose of batch production records 4
4.3.1 Overview 4
4.3.2 Process and/or production analysis, optimization and reporting4
4.3.3 Compliance 5
4.3.4 Production release 5
4.3.5 Deviation management 5
4.3.6 Quality Management 5
4.3.7 Material tracking and tracing 5
4.3.8 Device Tracking and Trace 5
4.3.9 People Tracking 5
4.3.10 Compliance with contract requirements 5
4.3.11 Cost accounting 5
4.3.12 Production knowledge base 6
4.4 Batch Production Record Data Management 6
4.4.1 Data retention 6
4.4.2 Data integrity 6
4.4.3 Creating batch records 6
4.4.4 Updating batch records 7
4.4.5 Life cycle state 7
4.5 Batch Record Structure 7
4.6 Production information 10
4.6.1 Overview 10
4.6.2 Business Information 11
4.6.3 Production Execution Information 11
4.6.4 Program element data 11
4.6.5 Generic (non-batch specific) data 12
4.7 Batch record element 13
5 Batch Record Object Model 16
5.1 Overview 16
5.2 Modeling information 16
5.3 Overview of the Batch Record Object Model 19
5.4 Batch Production Records 20
5.5 Batch production record entry 22
5.6 Event 23
5.7 Datasets 30
5.7.1 Dataset object 30
5.7.2 Dataset properties 32
5.7.3 Time specification 33
5.7.4 Label specification 33
5.7.5 Ordered data 34
5.7.6 Data value 34
5.7.7 Time value 35
5.8 Note 35
5.9 Sample 36
5.9.1 Sample objects 36
5.9.2 Sample properties 36
5.9.3 Sample test 37
5.9.4 Sample test results 37
5.10 Change 38
5.11 Personnel identification checklist 39
5.12 Resource Qualification Checklist 40
5.13 Product Definition 41
5.14 Production response 41
5.15 Production Request 41
5.16 Control Prescription 42
5.16.1 Controlling prescription objects 42
5.16.2 Controlling recipe attributes 43
5.16.3 Control recipe file header 44
5.16.4 Installation requirements 45
5.16.5 Constraints 46
5.16.6 Equation 46
5.16.7 Parameter 46
5.16.8 Parameter value 47
5.16.9 Program logic 48
5.16.10 Link 48
5.16.11 Step 48
5.16.12 Conversion 49
5.16.13 Other information 49
5.16.14 Other information value 50
5.16.15 Prescription elements 50
5.17 Primary prescription 52
6 Integrity, Conformity and Consistency 53
6.1 Integrity 53
6.2 Compliance 53
6.3 Consistency 53
6.4 Extended object model 53
Appendix A (Informative) Data Modeling Techniques 54
A.1 Terms and Definitions 54
A.2 UML notation 54
Appendix B (Informative) Questions and Answers 56
B.1 Overview 56
B.2 Levels of batch production record specification 56
B.3 Contents of batch production record specification 56
B.4 Format of batch production record specification56
B.5 Format of personal and computer identification in batch production records56
B.6 Reasons for recording data in the batch production record 56
B.7 How many audit trails are there for the same batch of production records 57
B.8 Recording discrete events 57
B.9 Production schedule and schedule changes 57
B.10 Material Safety Data Sheets 57
B.11 Label scanning 57
B.12 Production information 57
B.13 Device History 57
B.14 Regulated industries? 58
B.15 GB/T 19892.4 batch production records and ANSI/ISA95 standard 58
B.16 GB/T 19892.4 and ISA-95 Terminology 58
B.17 GB/T 19892.4 batch production records and ISA-95 production performance 59
B.18 What format is used for data citations? 59
B.19 Personnel conduct 59
References 60
Figure 1 Generation and use of batch production records 3
Figure 2 Batch production record component object 8
Figure 3 Batch Production Record Example 9
Figure 4 An example of an element referencing another element 10
Figure 5 Internal and Reference Data Example 10
Figure 6 Example of batch production records for recipe elements12
Fig. 7 Batch record with non-batch-specific data 13
Figure 8 Object Reference Model 18
Figure 9 Batch production record top-level model 19
Figure 10 Batch Production Record Object Model 20
Figure 11 Event Model 23
Figure 12 Example of event element relationship 24
Figure 13 Dataset model 31
Figure 14 Time series dataset example 31
Figure 15 Elements of Time Series Dataset 31
Figure 16 Cross-correlation dataset example 32
Figure 17 Element 32 of a cross-correlation dataset
Figure 18 Sample model 36
Figure 19 Control Prescription Model 42
Figure 20 Sample batch production record 43 with two copies of the control recipe
Figure 21 Prescription element model 51
Figure 22 Master prescription model 52
Table 1 Classification of batch production records13
Table 2 Table Example 19
Table 3 Batch Production Record Attributes 20
Table 4 Batch production record entry attribute 22
Table 5 Event attributes 24
Table 6 Alarm event attributes 26
Table 7 Standard event types 26
Table 8 Attributes of user-defined attributes 29
Table 9 Event Correlation Attributes 30
Table 10 Dataset properties 32
Table 11 Time specification attributes 33
Table 12 Label identification attribute 33
Table 13 Data value attribute 35
Table 14 time value attribute 35
Table 15 Annotation attributes 35
Table 16 Sample properties 36
Table 17 Sample Test Properties 37
Table 18 Sample Test Result Attributes 38
Table 19 Change properties 39
Table 20 Person ID list attribute 39
Table 21 Qualification Checklist Attribute 40
Table 22 Control recipe attributes 43
Table 23 Control Prescription Header Attributes 44
Table 24 Device Requirements Attributes 45
Table 25 Constraint properties 46
Table 26 Parameter properties 47
Table 27 Parameter value attribute 47
Table 28 Link properties 48
Table 29 Step properties 49
Table 30 Conversion properties 49
Table 31 Other Information Attributes 50
Table 32 Other information value attribute 50
Table 33 Prescription element attributes 51
Table 34 Main prescription attributes 52
Table A.1 UML notation 54
foreword
This document is in accordance with GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents" and
GB/T 1.2-2020 "Guidelines for Standardization Work Part 2.Rules for Drafting Standardization Documents Based on ISO /IEC Standardization Documents"
regulations drafted.
This document is part 4 of GB/T 19892 "Batch Control". GB/T 19892 has issued the following parts.
--- Part 1.Models and terminology;
--- Part 2.Data structure and language guidelines;
--- Part 3.General and field prescription models and representations;
--- Part 4.Batch production records.
This document is equivalent to IEC 61512-4.2008 "Batch Control Part 4.Batch Production Records".
This document is proposed by China Machinery Industry Federation.
This document is under the jurisdiction of the National Industrial Process Measurement Control and Automation Standardization Technical Committee (SAC/TC124).
This document is drafted by. Harbin Institute of Technology Special Robot Co., Ltd., Machinery Industry Instrumentation Comprehensive Technical and Economic Research Institute, Fujian
Shangrun Precision Instrument Co., Ltd., Qingdao Haier Industrial Intelligence Research Institute Co., Ltd., General Electric Power Planning Institute Co., Ltd., Shenyang Chinese Academy of Sciences
Automation Research Institute, Chongqing University of Posts and Telecommunications, Rockwell (China) Co., Ltd., Yokogawa Electric (China) Co., Ltd., Shanghai Industrial Automation Instrument
Watch Research Institute, Harbin Institute of Technology Robotics (Yueyang) Military-civilian Integration Research Institute, Beijing Institute of Technology, Shanghai Automation Instrument Co., Ltd., Phoenix
(Nanjing) Intelligent Manufacturing Technology Engineering Co., Ltd., Hangzhou Dianzi University, Wuxi Internet of Things Innovation Center Co., Ltd.
The main drafters of this document. Tang Xiaohan, Lu Tielin, Liu Xiaojing, Ge Jian, Sun Ming, Zhang Jinbin, Zhang Hualiang, Huang Qingqing, Gao Jingmei, Guan Qi,
Li Minghua, Sui Guofa, Kong Lingqin, Ye Bingjin, Zhang Long, Shen Jing, Xing Hao, Zhuang Baosen, Dong Jielian, Wang Yong, Liu Heyan.
Introduction
GB/T 19892 is a standard for batch process and guidance for batch control, consisting of four parts.
--- Part 1.Models and terminology. The purpose is to establish the model and terminology to be followed for batch control.
--- Part 2.Data Structures and Language Guidelines. The purpose is to illustrate the language's data structures and guidelines.
--- Part 3.General and field prescription models and representations. The purpose is to define additional information for generic and field prescriptions.
--- Part 4.Batch production records. The purpose is to provide a reference model for developing applications for storing and/or exchanging batch production records.
This document is further implemented to allow retrieval, analysis and reporting of selected batch record data, and to provide
Defined in detail, it consists of an object model that describes and batches the contents of records. Batch production record standards comply with GB/T 19892.2-2007
The batch data model in Chapter 4 and GB/T 19892.1.
Although this document is primarily directed to batch processes, it can also be referenced for other types of processes.
Batch control part 4.batch production records
1 Scope
This document defines a reference model for batch records containing information about batches or batch elements.
This document is suitable for batch processing.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 19892.1-2005 Batch Control Part 1.Models and Terminology (IEC 61512-1.1997, IDT)
GB/T 19892.2-2007 Batch Control Part 2.Data Structure and Language Guidelines (IEC 61512-2.2001, IDT)
ANSI/ISA-95.00.01-2000 Enterprise Control System Integration Part 1.Models and Terminology (Enterprise-controlsystem
ANSI/ISA-95.00.02-2001 Enterprise control system integration Part 1.Object model attributes (Enterprise-controlsys-
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
batch history batchhistory
Collect all execution information related to individual batches, which may include common (non-batch-specific) information.
3.2
A subset of executive and business information retained based on business requirements, identified in accordance with a batch production record specification.
NOTE. This information can include prescription program element execution information, device-specific information, operator notes, batch-related alarms, batch-definition-related elements such as
Control recipes, master recipes, field and/or generic recipes, batch scheduling information) and critical batch information (such as training logs, maintenance records, and environmental conditions).
3.3
Formatted information extracted from one or more batch records for printing, displaying, or sending to a collaborative system.
3.4
Data used for the generation of batch production records or contained in batch production records and specifications (if the data are used for reference or extraction)
Completed execution business information requirements definition.
NOTE. This information may include content, calculations, and other rules that require identifying relevant information.
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