Lonza Form/Checklist
Effective
19-Jul-2010
CMMS Technical Object and Preventative Maintenance Form
Doc.No
Replaces
USPO-2422
N/A
Version
Page
4.0
1
of
Full document title:
CMMS Technical Object and Preventative Maintenance Form
This document is intended solely for the use of Lonza Biologics Inc. employees and is not to be disseminated outside the Lonza Group. It may contain information that is
confidential and / or proprietary to Lonza Biologics Inc. or its customers. Inappropriate use of this information may result in disciplinary action.
Dieses Dokument ist einzig fr den Gebrauch innerhalb von Lonza Biologics Inc. vorgesehen und darf nicht ausserhalb von Lonza Group verwendet werden. Es kann
Informationen enthalten, die vertraulich und / oder Eigentum von Lonza Biologics Inc. oder seine Kunden sind. Unerlaubte Verwendung dieser Informationen kann zu
Disziplinrmassnahmen fhren.
Refer to USPO-8841 for instructions on filling out form.
Complete for SAP Technical Object Additions, Changes, or Deletions
Add
Change
Delete
N/A Section
GMP Relevant:
Yes
No
Description for Technical Object:
SAP Technical Object:
Superior Functional Location:
Associated Quality Document(s):
Manufacturer:
Model Number:
Serial Number:
P & ID Tag Number:
Location/Suite:
Room Number:
Main Work Center:
Cost Center:
Comments
:
See Rationale / Justification on Page 3
N/A
Working Copy information: form first saved by user on 12 Aug 10 and / or printed on 16 Aug 10
if a date above is after the documents effective date then user saved / printed the form on the date shown above
Lonza Form/Checklist
Effective
19-Jul-2010
CMMS Technical Object and Preventative Maintenance Form
Doc.No
Replaces
USPO-2422
N/A
Version
Page
4.0
2
of
Complete for Preventative Maintenance Additions, Changes, or Deletions
Add
Section
Change
Delete
N/A
Date First PM Due: N / A
Operations Work Center: SUIMAINT Suite
Maintenance
SAP Technical Object: P01-P4-AG701
Maintenance Plan Number: 561215
Task List Number: 16526
Task List Description: Quarterly Agitator Preventative Maint
PM Description: Quarterly Agitator PM AG701
Associated Quality Document(s): TW98636, TW98642
Recommended Frequency:
Manufacturers
Lonzas
PM Frequency: 3 Months
Rationale/Justification (required if deviating from Manufacturers recommendation):
Operation(s) Add rows as necessary
Operation
Number
0010
Operation Description
PERFORM INSPECTION AND
MAINTENANCE
Operation Long Text
Initial/Date 1.Perform Inspection and
maintenance of agitator assembly per USPO8680
Duration
(hrs)
Manufacturer
Recommendation
Lonza
Recommendation
Working Copy information: form first saved by user on 12 Aug 10 and / or printed on 16 Aug 10
if a date above is after the documents effective date then user saved / printed the form on the date shown above
Lonza Form/Checklist
Effective
19-Jul-2010
CMMS Technical Object and Preventative Maintenance Form
Doc.No
Replaces
USPO-2422
N/A
Version
Page
4.0
3
of
Operation(s) Add rows as necessary
Operation
Number
Operation Description
Operation Long Text
Duration
(hrs)
Manufacturer
Recommendation
Lonza
Recommendation
Rationale/Justification (required if deviating from manufacturers recommendation):
Description: Agitator, Magnetic Drive
Manufacturer: Mavag
Model: MDB 550
TWCAPA 79240 was initiated to implement a Preventative Maintenance Plan for bottom mount magnetic drive agitators. The CAPA
addresses variances from the manufacturers recommended maintenance; in the case of Mavag Magnetic Drive Agitators, variances
from recommended maintenance exist. These include motor and gear box systems which run to failure and require no preventative
maintenance. The manufacturers PM recommendations for impeller systems are consistent with the governing USPO-8680, Magnetic
Drive Agitator Maintenance. No additional preventative maintenance is required. See attached supporting documentation.
Working Copy information: form first saved by user on 12 Aug 10 and / or printed on 16 Aug 10
if a date above is after the documents effective date then user saved / printed the form on the date shown above
Lonza Form/Checklist
Effective
19-Jul-2010
CMMS Technical Object and Preventative Maintenance Form
Doc.No
Replaces
USPO-2422
N/A
Version
Page
4.0
4
of
Parts Required Add rows as necessary
N/A
SAP Part Number
06022400
Qty.
1
Part Description (Include Vendor Part Number)
Kit, Bearing, MAVAG, MDB550
Maintenance Plan Number (filled in by MPG):
Operation Number
Where Used
0010
Task List Number (filled in by MPG):
Working Copy information: form first saved by user on 12 Aug 10 and / or printed on 16 Aug 10
if a date above is after the documents effective date then user saved / printed the form on the date shown above
Lonza Form/Checklist
Effective
19-Jul-2010
CMMS Technical Object and Preventative Maintenance Form
Doc.No
Replaces
USPO-2422
N/A
Version
Page
4.0
5
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Approvals
Requestor
Print: Robert Kadlik
Signature:
Date:
Signature:
Date:
Signature:
Date:
Signature:
Date:
Signature:
Date:
Signature:
Date:
Maintenance
Print: Bob Briggs
Engineering
Print: Buster Miller
Quality Assurance
Print: Jim Nelson
MPG Supervision
Print:
SAP Data Entry and Notification to Requestor
Print:
Completed form filed by MPG in the SAP Technical Object files.
This is the last page of the document.
Remaining pages contain only version history.
Working Copy information: form first saved by user on 12 Aug 10 and / or printed on 16 Aug 10
if a date above is after the documents effective date then user saved / printed the form on the date shown above
Lonza Form/Checklist
Effective
19-Jul-2010
CMMS Technical Object and Preventative Maintenance Form
Doc.No
Replaces
USPO-2422
N/A
Version
Page
4.0
6
of
Version History
History for Version 4
Change Agent: Mike Wilson representing Engineering
Reference
in Effective
Version
Reference
in This
Version
All
All
Description of Change /
Scope of New Document
Complete re-write of form.
Reason/Justification for Change
Associated
References
(Deviation #, CC#, etc)
Edits to fields and general
reformatting required for streamlining
of form.
TW98636
TW98642
History for Version 3
Change Agent: Randall Spayd representing QA
Reference
in Effective
Version
Reference
in This
Version
All
All
Description of Change /
Scope of New Document
Re-write of document.
Reason/Justification for Change
Associated
References
(Deviation #, CC#, etc)
Additional details and clarification
needed.
FDA 483 21Apr10
History for Version 2
Change Agent: Tammy Craft representing Engineering
Reference
in Effective
Version
Reference
in This
Version
All
All
Description of Change /
Scope of New Document
Rewrite of document. Include fields for electronic data
entry.
Reason/Justification for Change
Associated
References
(Deviation #, CC#, etc)
Clarity and ease of use.
N/A
Lonza Form/Checklist
Effective
19-Jul-2010
CMMS Technical Object and Preventative Maintenance Form
Doc.No
Replaces
USPO-2422
N/A
Version
Page
4.0
7
of
History for Version 1
Change Agent: Georgette Goodman representing Engineering
Section / Step /
Page Reference
All
Description of Change /
Scope of New Document
New Document
Reason/Justification for Change
Form was not a GMP form prior to
this.
Associated References
(Deviation #, CC#, etc)
CAPK402, CAPM056
