1、 AMERICAN NATIONAL STANDARD ANSI/ISA88.00.012010 Batch Control Part 1: Models and Terminology Approved 6 December 2010 ANSI/ISA-88.00.01-2010 Batch Control Part 1: Models and Terminology ISBN: 978-1-936007-75-2 Copyright 2010 by ISA. All rights reserved. Not for resale. Printed in the United States
2、of America. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), without the prior written permission of the Publisher. ISA 67Alexander Drive P. O. Box 12277 Research
3、Triangle Park, North Carolina 27709 USA- 3 - ANSI/ISA-88.00.01-2010 CONTENTS 1 Scope 17 2 Normative references . 17 3 Terms, definitions and abbreviations. 18 3.1 Terms and definitions 18 3.1.1 Introduction . 18 3.2 Abbreviations 26 4 Batch processes and equipment . 27 4.1 Introduction. 27 4.2 Types
4、 of manufacturing . 27 4.2.1 Introduction . 27 4.2.2 Continuous process manufacturing 27 4.2.3 Discrete parts manufacturing . 27 4.2.4 Batch process manufacturing . 27 4.3 Process model 28 4.3.1 Introduction . 28 4.3.2 Process. 29 4.3.3 Process stage 29 4.3.4 Process operation 30 4.3.5 Process actio
5、n. 30 4.3.6 Collapsing and expanding the process model . 30 4.4 Equipment and equipment Control . 31 4.4.1 Introduction . 31 4.4.2 Physical model 31 4.4.3 Equipment entity model . 33 4.5 Process cell classification 40 4.5.1 Introduction . 40 4.5.2 Classification by number of products 40 4.5.3 Classi
6、fication by physical structure. 41 5 Structure for batch control 44 5.1 Introduction. 44 5.2 Basic control . 44 5.2.1 Introduction . 44 5.2.2 Basic control in equipment entities . 44 5.3 Procedural control. 45 5.3.1 Introduction . 45 5.3.2 Procedural control model . 46 5.3.3 Procedural control model
7、/physical model/process model relationship 49 5.3.4 Procedural control in equipment entities. 51 5.4 Coordination control 52 5.4.1 Introduction . 52 5.4.2 Allocation and arbitration . 52 5.4.3 Coordination control in equipment entities 53 ANSI/ISA-88.00.01-2010 - 4 -6 Recipes and procedural elements
8、. 55 6.1 Introduction. 55 6.2 Recipe types . 55 6.2.1 Introduction . 55 6.2.2 General recipe. 56 6.2.3 Site recipe. 56 6.2.4 Master recipe 57 6.2.5 Control recipe 57 6.3 Recipe contents 58 6.3.1 Introduction . 58 6.3.2 Header 58 6.3.3 Formula. 58 6.3.4 Equipment requirements 59 6.3.5 Procedure . 59
9、6.3.6 Other information. 59 6.4 Recipe components. 59 6.5 Recipe procedures by type of recipe 60 6.5.1 Introduction . 60 6.5.2 General recipe procedure 61 6.5.3 Site recipe procedure. 62 6.5.4 Master recipe procedure 62 6.5.5 Control recipe procedure . 64 6.6 Control recipe procedure/equipment contr
10、ol relationship 65 6.6.1 Introduction . 65 6.6.2 Linking recipe entities and equipment entities. 65 6.6.3 Linking recipe phases and equipment phases. 66 6.6.4 Linking recipe procedural elements and equipment procedural elements above the phase level 67 6.6.5 Control recipe procedure/equipment contro
11、l collapsibility 71 6.6.6 Linking recipe procedural elements and equipment procedural elements when using an expanded procedural control model. 72 7 Batch control considerations. 73 7.1 Introduction. 73 7.2 Process and control engineering tasks. 73 7.3 Modes and states 74 7.3.1 Introduction . 74 7.3
12、.2 Modes . 75 7.3.3 States . 77 7.4 Exception handling 78 7.5 Example procedural state model 80 7.5.1 Introduction . 80 7.5.2 Procedural states 80 7.5.3 Procedural commands . 82 7.6 Batch schedules 84 7.6.1 Introduction . 84 - 5 - ANSI/ISA-88.00.01-2010 7.6.2 Campaign 85 7.7 Production information 8
13、6 7.7.1 Introduction . 86 7.7.2 Batch-specific information 86 7.7.3 Common (non-batch specific) batch information . 87 7.7.4 Batch history . 87 7.7.5 Batch reports. 87 8 Activities and functions in batch control 89 8.1 Introduction. 89 8.2 Control activity model 89 8.2.1 Introduction . 89 8.2.2 Info
14、rmation handling 90 8.3 Recipe management 92 8.3.1 Introduction . 92 8.3.2 Manage general recipes. 92 8.3.3 Define general recipe procedural elements. 93 8.3.4 Manage site recipes. 94 8.3.5 Manage master recipes 94 8.3.6 Define master recipe procedural elements 94 8.4 Production planning and schedul
15、ing. 95 8.5 Production information management 96 8.5.1 Introduction . 96 8.5.2 Receiving and storing batch history information 97 8.5.3 Manipulating historical data . 100 8.5.4 Producing batch reports. 100 8.6 Process cell management 101 8.6.1 Introduction . 101 8.6.2 Manage batches 102 8.6.3 Track
16、and allocate process cell resources 104 8.6.4 Collect batch and process cell information 105 8.7 Unit supervision 106 8.7.1 Introduction . 106 8.7.2 Acquire and execute procedural elements 106 8.7.3 Manage unit resources 108 8.7.4 Collect batch and unit information 108 8.8 Process control . 109 8.8.
17、1 Introduction . 109 8.8.2 Execute procedural control 109 8.8.3 Execute basic control. 110 8.8.4 Collect data . 111 8.9 Personnel and environmental protection 111 9 Completeness, compliance and conformance 112 9.1 Completeness . 112 9.2 Compliance. 112 ANSI/ISA-88.00.01-2010 - 6 -9.3 Conformance 112
18、 Annex A (informative) Model philosophy 115 Annex B (informative) Overview of Part 1 Update . 117 Annex C (informative) Frequently asked questions . 139 C.1 Conformance and compliance 139 C.2 Multiple batches through units . 139 C.3 Further description of basic control 140 C.4 Further description of
19、 equipment modules 141 C.5 Batch manufacturing roles . 142 Product Responsibility Role. 142 Manufacturing Responsibility Role . 142 Automation Design Responsibility Role 143 C.6 Recipe building blocks. 143 C.7 Processing a recipe. 144 C.8 Exception handling details. 144 Annex D (informative) Referen
20、ce Procedural State Model. 145 D.1 Introduction . 145 D.2 Procedural States 146 D.3 Procedural Commands. 149 D.4 Using Collapsed or Expanded Versions of the Reference Procedural State Model. 152 Annex E (informative) Bibliography of safety references . 155 - 7 - ANSI/ISA-88.00.01-2010 Figures Figure
21、 1 Parts of this standard 15 Figure 2 Process model (instance diagram) when not collapsed or expanded 29 Figure 3 Physical model 32 Figure 4 Equipment entity model . 34 Figure 5 Equipment entity model examples 40 Figure 6 Single-path structure 41 Figure 7 Multiple-path structure 42 Figure 8 Network
22、structure . 43 Figure 9 Procedural control model (instance diagram) when not collapsed or expanded. 47 Figure 10 Typical process/procedure/equipment mapping to achieve process functionality 50 Figure 11 Recipe types model 55 Figure 12- Master recipe component encapsulation. 60 Figure 13 General reci
23、pe procedure model. 62 Figure 14 Master recipe procedure model 63 Figure 15 - Information flow from general recipe to equipment entity 66 Figure 16 Control recipe procedure referencing equipment procedural elements at the phase level. 67 Figure 17 Control recipe defined without phase level recipe pr
24、ocedural elements 69 Figure 18 Control recipe defined without operation level recipe procedural elements. 69 Figure 19 Control recipe defined without unit procedure level recipe procedural elements 70 Figure 20 Referencing equipment procedural elements at different levels within the same recipe proc
25、edure . 71 Figure 21 Control recipe procedure/equipment procedure collapsibility examples 72 Figure 22 Simultaneous definition/selection of procedural elements and equipment entities . 74 Figure 23 State transition diagram for example states for procedural elements 84 Figure 24 Control activity mode
26、l . 90 Figure 25 Recipe management . 93 Figure 26 Process cell management . 103 Figure 27 Unit supervision 107 Figure 28 Process control. 110 Figure 29 State transition diagram for the reference procedural state model 151 ANSI/ISA-88.00.01-2010 - 8 -Tables Table 1 Example modes . 77 Table 2 State de
27、scriptions in the example procedural state model . 81 Table 3 State transition matrix for example states for procedural elements 83 Table 4 State descriptions in the example full reference procedural state model 146 Table 5 State transition matrix for the reference procedural state model 150 - 9 - A
28、NSI/ISA-88.00.01-2010 Batch Control Part 1: Models and terminology FOREWORD This foreword, as well as all footnotes and annexes, is included for information purposes and is not part of ANSI/ISA-88.00.01-2010. This document has been prepared as part of the service of ISA, The International Society of
29、 Automation, toward a goal of uniformity in the field of automation. To be of real value, this document should not be static but should be subject to periodic review. Toward this end, the Society welcomes all comments and criticisms and asks that they be addressed to the Secretary, Standards and Pra
30、ctices Board; ISA; 67 Alexander Drive; P. O. Box 12277; Research Triangle Park, NC 27709; Telephone (919) 549-8411; Fax (919) 549-8288; E-mail: standardsisa.org. The ISA Standards and Practices Department/ endeavours to introduce SI-acceptable metric units in all new and revised standards, recommend
31、ed practices, and technical reports to the greatest extent possible. Standard for Use of the International System of Units (SI): The Modern Metric System, published by the American Society for Testing visit www.isa.org/standards) This revised Part 1 replaces ISA-88.01-1995. The major changes made to
32、 this standard from the previous version are: 1. Models and text are modified to provide more detail and clarity. Key clarifications are: a. All recipe-aware equipment modules contain procedural control b. Execution of all procedural control contained directly in units is part of the unit supervisio
33、n activity. c. The relationships between types of recipes, recipe components, and equipment control are more fully described and illustrated. d. Entity relationship diagrams have been replaced with more intuitive UML instance diagrams. e. The transition diagram for the procedural states example has
34、been updated with a more intuitive and complete UML state diagram. f. References to other standards in the series and to the ANSI/ISA-95 and IEC 62264-1 are included to provide direction for further clarification of selected topics. 2. Previous Clauses 4 through 6 (now 4 through 8) were rearranged t
35、o provide a clearer top down organization of the document. Key changes are: a. Simultaneous characterization of the physical and equipment entity model levels at and below the process cell to eliminate redundancy and clarify that the control in these entities is the basis for partitioning this part
36、of the physical model (see 4.3). - 11 - ANSI/ISA-88.00.01-2010 b. Combining the descriptions of basic, procedural, and coordination control with their usage in each type of equipment entity, providing a single consolidated discussion of each type of control (see Clause 5) c. Additional consideration
37、s to support application of the models have been grouped in Clause 7 to clarify their supporting relationship to the core models. 3. Clause 9 was added to define completeness, compliance, and conformance in relation to this standard. 4. Annex B was added to more fully describe the changes in this do
38、cument compared with the superseded 1995 version. 5. Annex C was added to clarify a number of points concerning the models, their application, and the new clause on conformance and compliance. 6. Annex D was added to provide a more expansive procedural state reference model. The model found in Claus
39、e 7 may be considered a collapsed version of this more general model. ANSI/ISA-88.00.01-2010 - 12 - The following served as active members of the ISA88 Part 1 Update Working Group: Name AffiliationPaul Nowicki, WG Chairman/Editor World Food Trace, Inc. / Heat and Control, Inc. Randy Dwiggins, WG Sec
40、retary and ISA88 Chair NNE Pharmaplan Mark Albano Honeywell Shawn Baker NNE Pharmaplan Cindy Benedict Siemens Dennis Brandl BR ANSI/ISA-88.00.01-2010 - 14 - responsible for specifying controls and the associated application programs for batch manufacturing plants; or involved in the design and marke
41、ting of products in the area of batch control. This standard provides standard models and terminology for defining the control requirements for batch manufacturing plants. The models and terminology defined in this standard: emphasize good practices for the design and operation of batch manufacturin
42、g plants; can be used to improve control of batch manufacturing plants; and can be applied regardless of the degree of automation. This standard provides standard terminology and a consistent set of concepts and models for batch manufacturing plants and batch control that are intended to improve com
43、munications between all parties involved, and to: reduce the users time to reach full production levels for new products; enable vendors to supply appropriate tools for implementing batch control; enable users to better identify their needs; make recipe development straightforward enough to be accom
44、plished without the services of a control systems engineer; reduce the cost of automating batch processes; and reduce life-cycle engineering efforts. It is important to note that although Clause 3 of this part of the standard provides definitions, the entire document constitutes the models and termi
45、nology of batch control. The user should consider Clause 3 as a short glossary of terms with brief descriptions and not rely on Clause 3 for a full understanding of the concepts. The full context of the terms will be found in the body of this standard. It is not the intent of this standard to sugges
46、t that there is only one way to implement or apply batch control; force users to abandon their current way of dealing with their batch processes; or restrict development in the area of batch control. The key concepts defined in this standard are: identification of structure and format for recipes an
47、d procedures; definition of levels of recipes and procedures; recognition of product specific recipes and procedures that are separate from process oriented equipment and its direct control; identification of a hierarchy of manufacturing equipment and its dedicated control; recognition of equipment
48、capabilities that are utilized during recipe and procedure driven production; and recognition of the need for modular and re-usable control functionality. The models presented in this standard are presumed to be complete as indicated. However, they may be collapsed and expanded as described in the e
49、xplanation of each model. The series of batch control standards has several parts, as shown in Figure 1. This Part 1 standard focuses on the definitions of process cells and units, master and control recipes, recipe - 15 - ANSI/ISA-88.00.01-2010 coordination control, and recipe procedural control. Other parts of the series have different focus areas which cover other aspects of batch manufacturing, from the product definitions at enterprises and sites to equipment control within units
