Installation Qualification
Prepared March 2003
Title
Heat Sealer - Installation Qualification
Products
Sterile Gizmos – Codes 12345 through 12789
Equipment To be Qualified:
Supplier Co., Model xyz, ABC Manufacturing
Equipment Register: MER 98-1248 / Heat Sealing
Process: SOP 20-12-14
Equipment Number
PPCN 98-364
Approval of the Validation Protocol
Sign here after reviewing and approving the document, standards and schedules
Title
Name
Signature
Date
Written By:
Approved By:
Validation Coordinator
Laboratory Manager
Operations Manager
Technical/ Quality Assurance
Manager
Design Engineer
19/5/06
page 1 of 11
Installation Qualification
Title: Name of item
Protocol #: IQP- xxx Ver 01
Page 2 of 11
Table of Contents
1
GENERAL INSTRUCTIONS AND PREREQUISITES .......................................................................... 3
1.1
1.2
1.3
1.4
OBJECTIVE AND SCOPE ................................................................................................................. 3
EQUIPMENT DESCRIPTION ............................................................................................................. 3
MAJOR COMPONENTS LIST ............................................................................................................ 3
TERMS AND DEFINITIONS ............................................................................................................... 4
2
RESPONSIBILITIES.............................................................................................................................. 4
3
DOCUMENTATION ............................................................................................................................... 5
3.1
3.2
4
COMPLETION OF THIS DOCUMENT .................................................................................................. 5
QUALIFICIATION DOCUMENTS LIST ................................................................................................. 5
UTILITIES , CONTACT SURFACES AND LUBRICANTS REQUIREMENTS..................................... 6
4.1
4.2
4.3
UTILITIES LIST ............................................................................................................................... 6
PRODUCT CONTACT COMPONENT MATERIAL .................................................................................. 6
LUBRICANTS.................................................................................................................................. 6
5
CALIBRATION ITEMS .......................................................................................................................... 7
6
VERIFICATION OF SOFTWARE AND CONTROL PROGRAMS........................................................ 7
7
INSTALLATION, HOOKUP, SAFETY, CLEANING AND PHYSICAL INSPECTION .......................... 8
8
PREVENTIVE MAINTENANCE AND SAFETY ASSESSMENTS ........................................................ 9
8.1
8.2
9
PREVENTATIVE MAINTENANCE ....................................................................................................... 9
SAFETY ASSESSMENT ................................................................................................................... 9
DEFICIENCY REPORT ATTACHMENTS LIST.................................................................................... 9
10
APPROVALS ................................................................................................................................... 10
10.1
10.2
11
INTERIM APPROVAL ..................................................................................................................... 10
FINAL APPROVAL ......................................................................................................................... 10
SIGNATURE RECORD.................................................................................................................... 11
19/5/06
page 2 of 11
Protocol #: IQP- xxx Ver 01
Installation Qualification
Title: Name of item
1
1.1
Page 3 of 11
General Instructions and Prerequisites
Objective and Scope
The different aspects that a normal protocol would address are:
I. Major Component List: eg motors etc. supplied with the equipment
II. Required Documents: a listing of all the documents necessary to provide a complete history of
the equipment and to ensure its correct operation, cleaning and maintenance
III. Utility Requirements
IV. Component Material: a listing of all the product contact components and their materials of
construction
V. Lubricants
VI. Calibration: instrumentation on the equipment and hence identify its criticality.
VII. Installation, Hookup, Safety, Cleaning and Physical Inspection
VIII.Preventive Maintenance Requirements
IX. Deficiency Report Attachment List: a list of the deficiency reports produced during the Installation
Qualification and their status.
X. Certification
This protocol will define the procedure to be followed for the installation qualification of the xxxxxx
Equipment No.: xxxxxxxxxxx. It is located in the Quality Control Laboratory.
1.2
Equipment Description
Required Information
Manufacturer
Purchase Order #
Model #
Equipment Identification #
Location
Drawing Number
Specification Number
1.3
As Found
Major Components List
Item #
Item Description
Speed Controller
Heating Blocks
Cooling Fan
Thermostat
Motor
19/5/06
Model/
Serial #
Manufacturer
Manual #
N/A
N/A
N/A
N/A
N/A
Product Contact
Surface
T YES
T YES
T YES
T YES
T YES
T NO
T NO
T NO
T NO
T NO
page 3 of 11
Protocol #: IQP- xxx Ver 01
Installation Qualification
Title: Name of item
1.4
Page 4 of 11
Terms and Definitions
Critical Deficiency – Validation may not be signed off until the item is closed out.
Non–Critical Deficiency – Validation may be signed off and (continued) use of the item is not impacted by
the deficiency.
Xxxxxxxx
2
Responsibilities
Activity
Prepare and approve protocol
Coordinate Validation Protocol Activitied
Execute Protocol and prepare report
Arrange laboratory testing (as required)
Prepare final report
Provide access to item
Approve Protocol
Provide contractor support and access
Approve final report
Approve Protocol
Execute Protocol
Provide laboratory testing (as required)
Approve final report
Responsible Party
Approval to Commence Execution of Protocol
Area Manager : _____________________ Date:_______________________
19/5/06
page 4 of 11
Installation Qualification
Title: Name of item
3
3.1
Protocol #: IQP- xxx Ver 01
Page 5 of 11
Documentation
Completion of this Document
This document is not to be copied. All results must be completed on the original document. The exception
to this being the Validation investigation form which can be copied as required. Each copy must be
approved, signed and dated.
All spaces provided in the OQ document must be completed. If a result is not applicable or not required
this should be stated in the space provided. If a number of spaces are not required, a diagnol line through
all spaces with a Not Applicable sign may be used.
This document must be completed in black or blue pen only.
3.2
Qualificiation Documents List
Document Type
Required?
(Yes/No)
Available?
(Yes/No)
Sign
Ref #
User Requirements
Functional Specification
Supplier Specification
Drawings
Fabrication Audit Report
Factory Acceptance Testing Report (FAT)
Suppliers Manual
Procedures for Maintenance
Procedures for Cleaning
Procedures for Set-up and Use
Other PCPs(list)
19/5/06
Verified by:
__________________
Date:
__________________
page 5 of 11
Protocol #: IQP- xxx Ver 01
Installation Qualification
Title: Name of item
4
Page 6 of 11
Utilities , Contact Surfaces and Lubricants Requirements
4.1
Utilities List
Utility
Requirements
As Measured
Acceptable? (Yes/No)
Sign
Electricity
Vacuum
Other
Verified by:
4.2
__________________
__________________
Product Contact Component Material
Product Contact Component
Verified by:
4.3
Date:
Material of Construction
__________________
Date:
Acceptable? (Yes/No)
Sign
__________________
Lubricants
Type
Verified by:
19/5/06
Manufacturer
Where is it
being used
__________________
Product Contact?
(Yes/ No)
Date:
Acceptable? (Yes/No)
Sign
__________________
page 6 of 11
Installation Qualification
Title: Name of item
5
Protocol #: IQP- xxx Ver 01
Page 7 of 11
Calibration Items
List all instrument and measuring devices – categorise into critical (under calibration) or not criticla for
indication only)s
Item #
Item Description
Critical
(Yes/No)
Verified by: __________________
6
Operating Range
Date:
Tolerance
Recalbration
Period
__________________
Verification of Software and Control Programs
Item Name
Software description
Class of
Software
(1/2/3/4/5/)
Verified by: __________________
19/5/06
Validation
Required ?
Date:
Serial
Number
Version
Number
(software)
Verified Present
and Acceptable by:
(signature and
date)
__________________
page 7 of 11
Protocol #: IQP- xxx Ver 01
Installation Qualification
Title: Name of item
7
Page 8 of 11
Installation, Hookup, Safety, Cleaning and Physical Inspection
Item
Equipment supplied as per
design specification?
List Requirements Here
Drawings of equipment
matched that of the
machine
Inspection Satisfactory
T Yes
T No T N/A
Safety Inspections
Verified that the item has
been earthed
Heating blocks made
aware to user that it is
dangerous / protective
cover
Emergency stop operates /
where to off the machine
immediately in times of
emergency
T Yes
T No
T N/A
T Yes
T No
T N/A
T Yes
T No
T N/A
Verify that the item has
been cleaned
Inspect the item for
cleanliness
T Yes
T No
T N/A
T Yes
T No
T N/A
Final Cleaning Inspection
Verified by:
19/5/06
__________________
Date:
Checked by
__________________
page 8 of 11
Protocol #: IQP- xxx Ver 01
Installation Qualification
Title: Name of item
8
8.1
Page 9 of 11
Preventive Maintenance and Safety Assessments
Preventative Maintenance
Verify that the Preventive Maintenance program has been logged in to the PM system.
T Verified
T Not Applicable
Verified by: ___________________________
8.2
Date: ________________
Safety Assessment
Verify that a Safety assessment is required and if so has been conducted
9
T Required
T Not required
T Completed (if required)
T Report Available
Conducted by: ___________________________
Date: ________________
Verified by: ___________________________
Date: ________________
Deficiency Report Attachments List
List deficiency reports produced during the Installation Qualification and their status. Refer to
attached detailed reports.
Deficiency
Report #
Deficiency Description Summary
Classification
Close out
Checked
Date
by
Critical
Non – Critical
Critical
Non – Critical
Critical
Non – Critical
19/5/06
page 9 of 11
Installation Qualification
Title: Name of item
Protocol #: IQP- xxx Ver 01
Page 10 of 11
10 Approvals
10.1 Interim Approval
If there are no outstanding Critical Validation Deficiency Investigations go to final approval. It there are
critical deficiencies withhold approvals. If the deficiencies are non-critical provide interim approval but not
final approval.
Title
Name
Signature
Date
Engineer
QA Manager
Production Manager
10.2
Final Approval
Provide final approval when ALL deficiencies are resolved and closed out.
Title
Name
Signature
Date
Engineer
QA Manager
Production Manager
Include Sheet of signatures of those involved with the validation activity
19/5/06
page 10 of 11
Installation Qualification
Title: Name of item
Protocol #: IQP- xxx Ver 01
Page 11 of 11
11 Signature Record
All personnel involved in this qualification must complete the table below to provide
identification of all the signatures/initials used in this document.
Company
19/5/06
Title
Name & Signature
Initials &
Date
page 11 of 11