ANSI ISA 88.00.04-2006 Batch Control Part 4 Batch Production Records《批量控制.第4部分 批量产品纪录》.pdf

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2、on. It may not be provided to any other person in print, electronic, or any other form. Violations of ISAs copyright will be prosecuted to the fullest extent of the law and may result in substantial civil and criminal penalties. STANDARD ISA-88.00.04-2006 Batch Control Part 4: Batch Production Recor

3、ds Approved 25 April 2006 ISA-88.00.04-2006 Batch Control Part 4: Batch Production Records ISBN: 978-1-55617-978-5 Copyright 2006 by ISA. All rights reserved. Not for resale. Printed in the United States of America. No part of this publication may be reproduced, stored in a retrieval system, or tran

4、smitted, in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), without the prior written permission of the Publisher. ISA 67 Alexander Drive P. O. Box 12277 Research Triangle Park, North Carolina 27709 USA 3 ISA-88.00.04-2006 Copyright 2006 ISA. All rights rese

5、rved. Preface This preface, as well as all footnotes and annexes, is included for information purposes and is not part of ISA-88.00.04-2006. This standard has been prepared as part of the service of ISA toward a goal of uniformity in the field of instrumentation. To be of real value, this document s

6、hould 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 Practices Board; ISA; 67 Alexander Drive; P. O. Box 12277; Research Triangle Park, NC 27709; Telephone (919)

7、 549-8411; Fax (919) 549-8288; E-mail: standardsisa.org. It is the policy of ISA to encourage and welcome the participation of all concerned individuals and interests in the development of ISA standards, recommended practices, and technical reports. Participation in the ISA standards-making process

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14、 USERS PARTICULAR CIRCUMSTANCES. THE USER MUST ALSO CONSIDER THE APPLICABILITY OF ANY GOVERNMENTAL REGULATORY LIMITATIONS AND ESTABLISHED SAFETY AND HEALTH PRACTICES BEFORE IMPLEMENTING THIS STANDARD. THE USER OF THIS DOCUMENT SHOULD BE AWARE THAT THIS DOCUMENT MAY BE IMPACTED BY ELECTRONIC SECURITY

15、 ISSUES. THE COMMITTEE HAS NOT YET ADDRESSED THE POTENTIAL ISSUES IN THIS VERSION. ISA-88.00.04-2006 4 Copyright 2006 ISA. All rights reserved. THE STANDARD IS STRUCTURED TO FOLLOW INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) GUIDELINES. THEREFORE, THE FIRST THREE CLAUSES PRESENT THE SCOPE OF THE

16、 STANDARD, NORMATIVE REFERENCES, AND DEFINITIONS, IN THAT ORDER. CLAUSE 4 IS INFORMATIVE. IT DESCRIBES THE PURPOSE, CONTENTS, LIFECYCLE AND USE OF BATCH PRODUCTION RECORDS. CLAUSE 5 IS NORMATIVE. IT DESCRIBES THE OBJECT MODEL ASSOCIATED WITH THE BATCH PRODUCTION RECORD. CLAUSE 6 IS NORMATIVE. IT STA

17、TES THE COMPLETENESS, COMPLIANCE, AND CONFORMANCE REQUIREMENTS FOR THIS STANDARD. ANNEX A IS INFORMATIVE. IT DEFINES THE DATA MODELING TECHNIQUES USED. ANNEX B IS INFORMATIVE. IT PRESENTS A LIST OF FREQUENTLY ASKED QUESTIONS AND ANSWERS ABOUT THIS STANDARD AS IT IS CURRENTLY ENVISIONED. THIS STANDAR

18、D IS INTENDED FOR THOSE WHO ARE: RESPONSIBLE FOR DEFINING PRODUCT PROCESSING REQUIREMENTS RESPONSIBLE FOR DEFINING PRODUCT REPORTING REQUIREMENTS INVOLVED IN DESIGNING AND/OR OPERATING BATCH MANUFACTURING PLANTS RESPONSIBLE FOR SPECIFYING CONTROLS AND THE ASSOCIATED APPLICATION PROGRAMS FOR BATCH MA

19、NUFACTURING PLANTS INVOLVED IN THE DESIGN AND MARKETING OF PRODUCTS IN THE AREA OF BATCH CONTROL USE PRODUCT INFORMATION FOR THE PURPOSES OF MANUFACTURING OR MANAGING THE MANUFACTURE OF PRODUCT The following individuals served as members of the ISA-SP88 Part 4 Working Group, which was responsible fo

20、r preparing this standard: NAME AFFILIATION K. Waters, Working Group Chair Genentech Inc D. Brandl, ISA-SP88 Chair BR while a batch production record designed to meet ad-hoc production analysis may have no formal lifecycle state. 4.5 Batch production record structure A batch production record is a c

21、ontainer for specific types of batch production information. A batch container may contain zero or more elements which are defined as objects in Clause 5. Figure 2 illustrates a sample batch record that contains one of each type of component container and multiple elements within each component cont

22、ainer. ISA-88.00.04-2006 24 Copyright 2006 ISA. All rights reserved. Figure 2 Batch production record component objects Some types of information are also containers and contain specific types of information, such as control recipe information containing the formula, header, and procedure informatio

23、n. Batch production records may also contain other batch production records. Figure 3 illustrates multiple containers using a subset of the batch production record component elements. Batch Production RecordControl RecipesEvents Data setsChange History PersonnelIdentifications Resource Qualification

24、s Production RequestsProduction ResponsesCommentsSamplesRecipe ElementsControl RecipeEvent MessageContinuous Trend DataChange HistoryElectronic Signature ManifestQualification ManifestProduction RequestProduction ResponseCommentSampleRecipe ElementControl RecipeEventData setChangePersonnel Ident. Ma

25、nifestQualification ManifestProduction RequestProduction ResponseCommentSampleRecipe ElementBatch Production Record Batch Production RecordBatch Production RecordProduct DefinitionsProduct DefinitionProduct DefinitionMaster RecipesControl RecipeMaster Recipe 25 ISA-88.00.04-2006 Copyright 2006 ISA.

26、All rights reserved. Batch Production RecordControl RecipesEventsData setsCommentsChange HistoryPersonnel IdentificationsSamplesResource QualificationsProduct DefinitionsProduction RequestsProduction ResponsesMaster RecipesRecipe ElementsControl RecipeBatch Production RecordFormulaHeaderProcedureFig

27、ure 3 Example of a batch production record Example: While a batch production record may contain any information, a typical use would be to contain a copy of the control recipe for a batch, a list of events that documented the events that occurred during the execution of the batch, continuous trend d

28、ata collected during the execution of the batch, and a production response to define the personnel and equipment used, the material consumed, and the material produced as a result of execution of a batch. Elements of a batch production record may reference other elements within the batch production

29、record, as illustrated in Figure 4. It shows an example with one change history that references a changed control recipe formula, two personnel identification manifests, and one comment that references a change history element. One personnel identification manifest identifies the person and “Done by

30、” action on the change history. The second identifies the person and “Checked by” action on the change history. The comment contains a comment associated with the change. ISA-88.00.04-2006 26 Copyright 2006 ISA. All rights reserved. Batch Production RecordChange HistoryControl RecipeChangeControlRec

31、ipesRecipe ElementControl RecipeFormulaHeaderProcedurePersonnelIdentificationsControl RecipePersonnel Identification ManifestCommentsControl RecipeCommentDone byChecked byFigure 4 Example of elements referencing another elements Elements of batch production records may contain the relevant informati

32、on or they may reference, or point to, the information in other data stores, such as databases as illustrated in Figure 5. It illustrates two cases of continuous trend data, where one element contains the trend data and the other element references an external database with the data. Batch Productio

33、n RecordDatabaseSamplesSampleSampleData setsContinuous Trend DataData set dataControl RecipesEventsControl RecipeEvent MessageControl RecipeEventReferenceFigure 5 - Example of internal and referenced data 4.6 Production information Production information is defined in the Part 1 standard. Production

34、 information is information that is collected during the course of production. It may include information collected prior to the start of production and information that is collected after the production of the batch. Production information may be batch specific or it may be common to several batche

35、s. Production information may also include other 27 ISA-88.00.04-2006 Copyright 2006 ISA. All rights reserved. types of information such as: training records, discrepancy system information, and information from suppliers. Production information is made up of business information and production exec

36、ution information. The determination if an information source is business information or production execution information is determined by business rules. 4.6.1 Business information Business information is data from non-production business systems, such as: HR (Human Resource), CRM (Customer Relatio

37、nship Management), PLM (Product Lifecycle Management), finance, and SCM (Supply Chain Management) systems. Example: Business information includes but is not limited to: General and site recipes Training data Certificate of analysis (COA) Material safety data sheets (MSDS) Customer information Cost a

38、nd quality information on raw materials Maintenance history of equipment Production schedule (see ANSI/ISA-95.00.01-2000) 4.6.2 Production execution information Production execution information is data from production resources such as equipment, material, energy, and personnel; the definition of pr

39、oduction rules; production history; and information on the processing environment. Example: Execution information includes: Master/control recipes Recipe parameters Schedule information Historical trending data Material quantity and property information Equipment status Equipment and control softwar

40、e configuration ISA-88.00.04-2006 28 Copyright 2006 ISA. All rights reserved. Standard operating procedures (SOPs) Environmental conditions Alarms and abnormal events Information on the physical processing equipment and its configuration(s) Work instructions used by operators 4.6.3 Procedural elemen

41、t data A batch production record may contain data about any recipe or equipment procedural element smaller than a complete batch, such as a unit procedure, operation, or phase. In this case the batch production record may contain a Recipe Element object that contains data on the associated procedura

42、l element. The procedural element may also contain data on any expanded procedural element hierarchy, when the standard procedural hierarchy has been extended in the control recipe. Figure 6 shows a sample batch production record that contains a recipe element and events related to the recipe elemen

43、t execution. NOTE The recipe element data may be used to describe equipment procedural information if the equipment recipes follow the appropriate structure Batch Production RecordEventsEvent MessageEventRecipeElementsRecipe ElementRecipe ElementFormulaHeaderProcedureUnit procedure, operation, phase

44、, or any expanded procedural element.Events in procedural element such as start of phase, end of phase.Figure 6 Sample batch production record for a recipe element 4.6.4 Common (non-batch specific) data Over the lifecycle of a batch there may be non-batch specific data that is stored in a batch prod

45、uction record. Non-batch specific data may be represented in a batch production record. Example 1: Non-batch specific data may include: 29 ISA-88.00.04-2006 Copyright 2006 ISA. All rights reserved. Ambient temperature and humidity History of equipment modifications and maintenance Steam system press

46、ure (trend or high/low exceptions) Example 2: A water analysis sample may be taken prior to the start of a batch. The water sampled may be used in multiple batches, but is not allocated to specific batches prior to its use. Therefore, each batch production record may need to include the water analys

47、is results for the sample taken prior to its use from the water source used. Example 3: Storage and handling data for a lot of intermediate material produced in a single batch that will be used as a raw material in multiple batches. Example 4: Non-batch specific data may be represented in a batch pr

48、oduction record, which does not include batch identification information, such as a continuous trend. Figure 7 illustrates a batch production record containing two batch production records. The top level batch production record contains common data, such as data sets of environmental trends, and the

49、 inner batch production record contains the batch-related data set data within a batch production record. Batch Production RecordData setsEvent MessageBatch Production RecordData setControlRecipeRecipe ElementControl RecipeFormulaHeaderProcedureNon batch related informationBatch related informationData setsEvent MessageData setFigure 7 Batch production record with non-batch specific data ISA-88.00.04-2006 30 Copyright 2006 ISA. All rights reserved. 4.7 Batch