Installation Qualification Equipment sample

[Pages:5]Project:

Equipment Description: Manufacturer: Location:

Installation Qualification Equipment

(Reference SOP: __________)

Project No: Serial No:

Model No: Protocol:

TEM-170 Issue date

Equipment No:

PROGRAM INDEX

1. OBJECTIVE..................................................................................................................................3 2. ACCEPTANCE CRITERIA............................................................................................................3 3. QUALIFICATION PROCEDURES ................................................................................................3 4. DEMAND SPECIFICATIONS........................................................................................................4 5. EQUIPMENT - MECHANICAL ......................................................................................................4

5.1. List of drawings.....................................................................................................................4 5.2. List of Supplier Quotes & Purchase Orders for Major Components.......................................5 5.3. List of Equipment / Maintenance Manuals. ...........................................................................5 6. EQUIPMENT FEATURES.............................................................................................................6 6.1. Manufacturer's Specifications...............................................................................................6 6.2. Component Materials in Product Contact..............................................................................6 6.3. Component Materials (as detailed in design spec.) not in Product Contact...........................7 6.4. Filters: ..................................................................................................................................7 6.5. Lubricants.............................................................................................................................8 6.6. Equipment SOP's .................................................................................................................8 6.7. Spare Parts List Location: ..................................................................................................9 6.8. Can machine adjustment be made without potential for product contamination? ..................9 7. ELECTRICAL INSTALLATION......................................................................................................9 7.1. Electrical Drawings ...............................................................................................................9 7.2. Equipment Rating ...............................................................................................................10 7.3. Supply Wiring .....................................................................................................................10 7.4. Distribution Details..............................................................................................................11 7.5. Instrumentation...................................................................................................................11 7.6. Calibration SOP's ...............................................................................................................12 7.7. Computerised Systems Verification ....................................................................................12 7.8. Spare Parts List:.................................................................................................................14 8. AUXILIARY EQUIPMENT / SERVICES LIST..............................................................................15 9. CHANGE PARTS .......................................................................................................................15 10. CLEANING PROCEDURES .......................................................................................................15 10.1. SOP's .................................................................................................................................15 10.2. Cleaning Records ...............................................................................................................16 11. PREVENTATIVE MAINTENANCE..............................................................................................16 11.1. Preventative Maintenance Program Identification: ..............................................................16 12. TRAINING RECORDS................................................................................................................16 13. COMMISSIONING OVERVIEW ..................................................................................................16 13.1. Equipment Operation..........................................................................................................16 13.2. Process Operation..............................................................................................................16 14. DISCREPANCIES.......................................................................................................................17 15. SIGNATURE LOG ......................................................................................................................17 16. ATTACHMENTS.........................................................................................................................17

Prepared by:

Date Prepared:

Revision No: Page 1 of 17

Installation Qualification Equipment

(Reference SOP: __________)

TEM-170 Issue date

4. DEMAND SPECIFICATIONS

The list below indicates the Demand Specifications that have been applied to this project. All Demand Specifications will be filed away with this Installation Report.

Demand Specifications Available

1. Equipment Functional Demand Specification 2. Mechanical / Design Specification 3. Electrical Demand Specification 4. Instrumentation Demand Specification 5. Operator's Control Panel Specification 6. SCADA Demand Specification 7. Technical Documentation Specification 8. Safety Requirements * = Please attach if Yes

Used in this Project* Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No

Yes/No

5. EQUIPMENT - MECHANICAL Complete a list of drawings, P&I's, specifications, purchase orders & manuals associated with the equipment/system. Document Location of the latest versions. Verify the accuracy of those drawings which represent the system "as built".

5.1. List of drawings.

5.1.1. Equipment

Drawing ID Rev. No.

Description

Location

As Built Verified Yes No

Date

Verified by

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Date Prepared:

Revision No: Page 4 of 17

Installation Qualification for Equipment

(Reference SOP: _________)

TEM-170 Issue date

6.5. Lubricants Use this list to verify that the lubricants used in the system conform to the equipment manufacturer's specification or those specified by the company.

6.5.1. List Lubricants in Product Contact:

Lubricant Name

Description

Used For

Verified Verified by: Yes No

6.5.2. List Lubricants (as detailed in design spec.) NOT in Product Contact:

List only those Lubricants detailed in the Design Specification.

Lubricant Name

Description

Used For

Verified Verified by: Yes No

6.6. Equipment SOP's List all SOP's currently available or requiring to be written pertinent to the proper operation of the unit. Ensure you reference the current version.

S.O.P. No:

Title

Date Issued

Prepared by:

Date Prepared:

Revision No: Page 8 of 17

Installation Qualification for Equipment

(Reference SOP: _________)

TEM-170 Issue date

7.6. Calibration SOP's List all SOP's pertinent to the calibration of the unit.

Ensure you reference the current version.

S.O.P. No:

Title

Date Issued

7.7. Computerised Systems Verification

7.7.1. Software

Check the microprocessors for functionality, program description and logic flow for all intended programs. Input and output checks, contactor state and indicator lights operation are to be checked. Installation verification

Software/Equipment:

Check

Applications program on hand and annotated to describe process or function ? User Requirement Specification. Logic flow diagram or program description chart available and reviewed ? Functional Specification. Loaded programs approved. Confirm that software is installed as per vendor instructions. Software Version Installed Ensure archiving and backup procedures followed Source code availability

Location

Verified Yes No

Verified by

N/A

Date

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Date Prepared:

Revision No: Page 12 of 17

Installation Qualification for Equipment

(Reference SOP: _________)

10.2. Cleaning Records

TEM-170 Issue date

Record in what form cleaning records are to be kept and where e.g. log book, as a part of batch documents.

11. PREVENTATIVE MAINTENANCE

11.1. Preventative Maintenance Program Identification: Program identification and records. For each piece of equipment list the maintenance Task Number and maintenance period:

Equipment

Task No.

Maintenance Period

12. TRAINING RECORDS

Personnel

Type of Training

State SOP/ Training Signed by Trainee Module delivered

13. COMMISSIONING OVERVIEW

13.1. Equipment Operation

Equipment

Equipment Date run

No.

Operation/s & duration

Report Operated

Doc. No.

by:

13.2. Process Operation

Process

Date run

Operation/s & duration

OK Yes No

Report Operated

Doc. No.

by:

Prepared by:

Date Prepared:

Revision No: Page 16 of 17

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