ISA 88 00 04-2006 Batch Control Part 4 Batch Production Records《批量控制 第4部分 生产批号记录》.pdf

1、 ANSI/ISA-88.00.04-2006 STANDARDBatch Control Part 4: Batch Production Records Approved April 25, 2006 ANSI/ISA-88.00.04-2006 Batch Control Part 4: Batch Production Records ISBN 10: 1-55617-978-2 ISBN 13: 978-1-55617-978-5 Copyright 2006 by ISA. All rights reserved. Not for resale. Printed in the Un

2、ited States 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 67 Alexander Drive P. O. Box 12

3、277 Research Triangle Park, North Carolina 27709 USA 3 ANSI/ISA-88.00.04-2006 Copyright 2006 ISA. All rights reserved. Preface This preface, as well as all footnotes and annexes, is included for information purposes and is not part of ANSI/ISA-88.00.04-2006. This standard has been prepared as part o

4、f the service of ISA toward a goal of uniformity in the field of instrumentation. 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, Stan

5、dards and Practices 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. It is the policy of ISA to encourage and welcome the participation of all concerned individuals and interests in the developm

6、ent of ISA standards, recommended practices, and technical reports. Participation in the ISA standards-making process by an individual in no way constitutes endorsement by the employer of that individual, of ISA, or of any of the standards, recommended practices, and technical reports that ISA devel

7、ops. CAUTION ISA ADHERES TO THE POLICY OF THE AMERICAN NATIONAL STANDARDS INSTITUTE WITH REGARD TO PATENTS. IF ISA IS INFORMED OF AN EXISTING PATENT THAT IS REQUIRED FOR USE OF THE STANDARD, IT WILL REQUIRE THE OWNER OF THE PATENT TO EITHER GRANT A ROYALTY-FREE LICENSE FOR USE OF THE PATENT BY USERS

8、 COMPLYING WITH THE STANDARD OR A LICENSE ON REASONABLE TERMS AND CONDITIONS THAT ARE FREE FROM UNFAIR DISCRIMINATION. EVEN IF ISA IS UNAWARE OF ANY PATENT COVERING THIS STANDARD, THE USER IS CAUTIONED THAT IMPLEMENTATION OF THE STANDARD MAY REQUIRE USE OF TECHNIQUES, PROCESSES, OR MATERIALS COVERED

9、 BY PATENT RIGHTS. ISA TAKES NO POSITION ON THE EXISTENCE OR VALIDITY OF ANY PATENT RIGHTS THAT MAY BE INVOLVED IN IMPLEMENTING THE STANDARD. ISA IS NOT RESPONSIBLE FOR IDENTIFYING ALL PATENTS THAT MAY REQUIRE A LICENSE BEFORE IMPLEMENTATION OF THE STANDARD OR FOR INVESTIGATING THE VALIDITY OR SCOPE

10、 OF ANY PATENTS BROUGHT TO ITS ATTENTION. THE USER SHOULD CAREFULLY INVESTIGATE RELEVANT PATENTS BEFORE USING THE STANDARD FOR THE USERS INTENDED APPLICATION. HOWEVER, ISA ASKS THAT ANYONE REVIEWING THIS STANDARD WHO IS AWARE OF ANY PATENTS THAT MAY IMPACT IMPLEMENTATION OF THE STANDARD NOTIFY THE I

11、SA STANDARDS AND PRACTICES DEPARTMENT OF THE PATENT AND ITS OWNER. ADDITIONALLY, THE USE OF THIS STANDARD MAY INVOLVE HAZARDOUS MATERIALS, OPERATIONS OR EQUIPMENT. THE STANDARD CANNOT ANTICIPATE ALL POSSIBLE APPLICATIONS OR ADDRESS ALL POSSIBLE SAFETY ISSUES ASSOCIATED WITH USE IN HAZARDOUS CONDITIO

12、NS. THE USER OF THIS STANDARD MUST EXERCISE SOUND PROFESSIONAL JUDGMENT CONCERNING ITS USE AND APPLICABILITY UNDER THE USERS PARTICULAR CIRCUMSTANCES. THE USER MUST ALSO CONSIDER THE APPLICABILITY OF ANY GOVERNMENTAL REGULATORY LIMITATIONS AND ESTABLISHED SAFETY AND HEALTH PRACTICES BEFORE IMPLEMENT

13、ING THIS STANDARD. THE USER OF THIS DOCUMENT SHOULD BE AWARE THAT THIS DOCUMENT MAY BE IMPACTED BY ELECTRONIC SECURITY ISSUES. THE COMMITTEE HAS NOT YET ADDRESSED THE POTENTIAL ISSUES IN THIS VERSION. ANSI/ISA-88.00.04-2006 4 Copyright 2006 ISA. All rights reserved. THE STANDARD IS STRUCTURED TO FOL

14、LOW INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) GUIDELINES. THEREFORE, THE FIRST THREE CLAUSES PRESENT THE SCOPE OF THE STANDARD, NORMATIVE REFERENCES, AND DEFINITIONS, IN THAT ORDER. CLAUSE 4 IS INFORMATIVE. IT DESCRIBES THE PURPOSE, CONTENTS, LIFECYCLE AND USE OF BATCH PRODUCTION RECORDS. CLAU

15、SE 5 IS NORMATIVE. IT DESCRIBES THE OBJECT MODEL ASSOCIATED WITH THE BATCH PRODUCTION RECORD. CLAUSE 6 IS NORMATIVE. IT STATES THE COMPLETENESS, COMPLIANCE, AND CONFORMANCE REQUIREMENTS FOR THIS STANDARD. ANNEX A IS INFORMATIVE. IT DEFINES THE DATA MODELING TECHNIQUES USED. ANNEX B IS INFORMATIVE. I

16、T PRESENTS A LIST OF FREQUENTLY ASKED QUESTIONS AND ANSWERS ABOUT THIS STANDARD AS IT IS CURRENTLY ENVISIONED. THIS STANDARD IS INTENDED FOR THOSE WHO ARE: RESPONSIBLE FOR DEFINING PRODUCT PROCESSING REQUIREMENTS RESPONSIBLE FOR DEFINING PRODUCT REPORTING REQUIREMENTS INVOLVED IN DESIGNING AND/OR OP

17、ERATING BATCH MANUFACTURING PLANTS RESPONSIBLE FOR SPECIFYING CONTROLS AND THE ASSOCIATED APPLICATION PROGRAMS FOR BATCH MANUFACTURING 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 MANUFA

18、CTURE OF PRODUCT The following individuals served as members of the ISA-SP88 Part 4 Working Group, which was responsible for 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 pro

19、duction analysis may have no formal lifecycle state. 4.5 Batch production record structure A batch production record is a container 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

20、 sample batch record that contains one of each type of component container and multiple elements within each component container. ANSI/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 co

21、ntain specific types of information, such as control recipe information containing the formula, header, and procedure information. Batch production records may also contain other batch production records. Figure 3 illustrates multiple containers using a subset of the batch production record componen

22、t elements. Batch Production RecordControl RecipesEvents Data setsChange History PersonnelIdentifications Resource Qualifications Production RequestsProduction ResponsesCommentsSamplesRecipe ElementsControl RecipeEvent MessageContinuous Trend DataChange HistoryElectronic Signature ManifestQualificat

23、ion ManifestProduction RequestProduction ResponseCommentSampleRecipe ElementControl RecipeEventData setChangePersonnel Ident. ManifestQualification ManifestProduction RequestProduction ResponseCommentSampleRecipe ElementBatch Production RecordBatch Production RecordBatch Production RecordProduct Def

24、initionsProduct DefinitionProduct DefinitionMaster RecipesControl RecipeMaster Recipe 25 ANSI/ISA-88.00.04-2006 Copyright 2006 ISA. All rights reserved. Batch Production RecordControl RecipesEventsData setsCommentsChange HistoryPersonnel IdentificationsSamplesResource QualificationsProduct Definitio

25、nsProduction RequestsProduction ResponsesMaster RecipesRecipe ElementsControl RecipeBatch Production RecordFormulaHeaderProcedureFigure 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

26、 recipe for a batch, a list of events that documented the events that occurred during the execution of the batch, continuous trend data 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

27、as a result of execution of a batch. Elements of a batch production record may reference other elements within the batch production 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

28、, and one comment that references a change history element. One personnel identification manifest identifies the person and “Done by” 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 chang

29、e. ANSI/ISA-88.00.04-2006 26 Copyright 2006 ISA. All rights reserved. Batch Production RecordChange HistoryControl RecipeChangeControlRecipesRecipe ElementControl RecipeFormulaHeaderProcedurePersonnelIdentificationsControl RecipePersonnel Identification ManifestCommentsControl RecipeCommentDone byCh

30、ecked byFigure 4 Example of elements referencing another elements Elements of batch production records may contain the relevant information 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 t

31、rend data, where one element contains the trend data and the other element references an external database with the data. Batch Production RecordDatabaseSamplesSampleSampleData setsContinuous Trend DataData set dataControl RecipesEventsControl RecipeEvent MessageControl RecipeEventReferenceFigure 5

32、- Example of internal and referenced data 4.6 Production information Production information is defined in the Part 1 standard. Production information is information that is collected during the course of production. It may include information collected prior to the start of production and informatio

33、n that is collected after the production of the batch. Production information may be batch specific or it may be common to several batches. Production information may also include other 27 ANSI/ISA-88.00.04-2006 Copyright 2006 ISA. All rights reserved. types of information such as: training records,

34、 discrepancy system information, and information from suppliers. Production information is made up of business information and production execution information. The determination if an information source is business information or production execution information is determined by business rules. 4.6

35、.1 Business information Business information is data from non-production business systems, such as: HR (Human Resource), CRM (Customer Relationship Management), PLM (Product Lifecycle Management), finance, and SCM (Supply Chain Management) systems. Example: Business information includes but is not l

36、imited to: General and site recipes Training data Certificate of analysis (COA) Material safety data sheets (MSDS) Customer information Cost and quality information on raw materials Maintenance history of equipment Production schedule (see ANSI/ISA-95.00.01-2000) 4.6.2 Production execution informati

37、on Production execution information is data from production resources such as equipment, material, energy, and personnel; the definition of production rules; production history; and information on the processing environment. Example: Execution information includes: Master/control recipes Recipe para

38、meters Schedule information Historical trending data Material quantity and property information Equipment status Equipment and control software configuration ANSI/ISA-88.00.04-2006 28 Copyright 2006 ISA. All rights reserved. Standard operating procedures (SOPs) Environmental conditions Alarms and ab

39、normal events Information on the physical processing equipment and its configuration(s) Work instructions used by operators 4.6.3 Procedural element data A batch production record may contain data about any recipe or equipment procedural element smaller than a complete batch, such as a unit procedur

40、e, operation, or phase. In this case the batch production record may contain a Recipe Element object that contains data on the associated procedural element. The procedural element may also contain data on any expanded procedural element hierarchy, when the standard procedural hierarchy has been ext

41、ended in the control recipe. Figure 6 shows a sample batch production record that contains a recipe element and events related to the recipe element execution. NOTE The recipe element data may be used to describe equipment procedural information if the equipment recipes follow the appropriate struct

42、ure Batch Production RecordEventsEvent MessageEventRecipeElementsRecipe ElementRecipe ElementFormulaHeaderProcedureUnit procedure, operation, phase, 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 reci

43、pe 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 production record. Non-batch specific data may be represented in a batch production record. Example 1: Non-batch specific data may include: 29 ANSI/ISA-88.00

44、.04-2006 Copyright 2006 ISA. All rights reserved. Ambient temperature and humidity History of equipment modifications and maintenance Steam system pressure (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 m

45、ultiple batches, but is not allocated to specific batches prior to its use. Therefore, each batch production record may need to include the water analysis 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

46、 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 production record, which does not include batch identification information, such as a continuous trend. Figure 7 illustrates a batch production record

47、 containing two batch production records. The top level batch production record contains common data, such as data sets of environmental trends, and the inner batch production record contains the batch-related data set data within a batch production record. Batch Production RecordData setsEvent Mess

48、ageBatch Production RecordData setControlRecipeRecipe ElementControl RecipeFormulaHeaderProcedureNon batch related informationBatch related informationData setsEvent MessageData setFigure 7 Batch production record with non-batch specific data ANSI/ISA-88.00.04-2006 30 Copyright 2006 ISA. All rights reserved. 4.7 Batch production record elements A batch production record may contain data about the following general categories of batch production information, defined in Table 1. This table relates the general categories of batch production information to the objects identified in Clause 5.