IEC PAS 61512-4:2007
(Main)Batch control - Part 4: Batch production records
Batch control - Part 4: Batch production records
It defines a reference model for batch production records containing information about production of batches or elements of batch production. This PAS is intended for batch processes.
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IEC/PAS 61512-4
Edition 1.0 2007-11
PUBLICLY AVAILABLE
SPECIFICATION
PRE-STANDARD
Batch control – Part 4: Batch production records
IEC/PAS 61512-4:2007(E)
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IEC/PAS 61512-4
Edition 1.0 2007-11
PUBLICLY AVAILABLE
SPECIFICATION
PRE-STANDARD
Batch control – Part 4: Batch production records
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XB
ICS 25.040.40 ISBN 2-8318-9407-7
– 2 – PAS 61512-4 © IEC:2007(E)
CONTENTS
FOREWORD.5
INTRODUCTION.7
1 Scope.8
2 Normative references .8
3 Terms and definitions.8
4 Batch production record description.9
4.1 Introduction .9
4.2 Batch production record .10
4.3 Batch production record purpose.12
4.4 Batch production record data management.14
4.5 Batch production record structure.16
4.6 Production information .18
4.7 Batch production record elements .21
5 Batch production record object model.24
5.1 Introduction .24
5.2 Modelling information .24
5.3 Batch production record object model overview .27
5.4 Batch production record .29
5.5 Batch production record entry.31
5.6 Event .31
5.7 Data set .38
5.8 Comment.42
5.9 Sample.43
5.10 Change .45
5.11 Personnel identification manifest .46
5.12 Resource qualification manifest.47
5.13 Product definition .48
5.14 Production response .48
5.15 Production request .49
5.16 Control recipe.49
5.17 Recipe element .57
5.18 Master recipe .58
6 Completeness, compliance and conformance .59
6.1 Completeness .59
6.2 Compliance .60
6.3 Conformance.60
6.4 Extending the object model .60
Annex A (informative) Data modelling technique .61
Annex B (informative) Questions and answers .63
Figure 1– Batch production record creation and use .10
Figure 2 – Batch production record component objects .16
Figure 3 – Example of a batch production record .17
PAS 61512-4 © IEC:2007(E) – 3 –
Figure 4 – Example of elements referencing another element .18
Figure 5 – Example of internal and referenced data .18
Figure 6 – Sample batch production record for a recipe element.20
Figure 7 – Batch production record with non-batch specific data .21
Figure 8 – Object reference model .27
Figure 9 – Batch production record top level model.28
Figure 10 – Batch production record object model .29
Figure 11 – Event model .32
Figure 12 – Example of event element relationships .33
Figure 13 – Data set model.38
Figure 14 – Sample time series data set .39
Figure 15 – Elements of a time series data set.39
Figure 16 – Sample correlated data set.39
Figure 17 – Elements of a correlated data set.39
Figure 18 – Sample model .43
Figure 19 – Control recipe model .50
Figure 20 – Sample batch production record with two control recipe copies .50
Figure 21 – Recipe element model.58
Figure 22 – Master recipe model.59
Table 1 – Batch production record categories .21
Table 2 – Table example.27
Table 3 – Batch production record attributes.29
Table 4 – Batch production record entry attributes .31
Table 5 – Event attributes .33
Table 6 – Alarm event attributes .34
Table 7 – Standard event types .35
Table 8 – User-defined attribute attributes .37
Table 9 – Event association attributes .38
Table 10 – Data set attributes .40
Table 11 – Time specification attributes .40
Table 12 – Tag identification attributes .41
Table 13 – Data value attributes .42
Table 14 – Time value attributes .42
Table 15 – Comment attributes .43
Table 16 – Sample attributes .44
Table 17 – Sample test attributes.45
Table 18 – Sample test result attributes .45
Table 19 – Change attributes .46
Table 20 – Personnel identification manifest attributes .47
Table 21 – Qualification manifest attributes .48
Table 22 – Control recipe attributes .51
Table 23 – Control recipe header attributes .52
– 4 – PAS 61512-4 © IEC:2007(E)
Table 24 – Equipment requirement attributes .53
Table 25 – Constraint attributes .53
Table 26 – Parameter attributes.54
Table 27 – Parameter value attributes .54
Table 28 – Link attributes .55
Table 29 – Step attributes.56
Table 30 – Transition attributes.56
Table 31 – Other information attributes .57
Table 32 – Other information value attributes.57
Table 33 – Recipe element attributes.58
Table 34 – Master recipe attributes.59
Table A.1 – UML notation .61
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