Installation Qualification Equipment

Issue date

Installation Qualification Equipment

(Reference SOP: __________)

Project:
Project No:
Equipment Description:
Serial No:
Manufacturer:
Model No:
Equipment No:
Location:
Protocol:

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.

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.

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.

7.7. Computerised Systems Verification ................................ ................................ .................... 12

7.8. Spare Parts List:................................ ................................ ................................ ................. 14

8. AUXILIARY EQUIPMENT / SERVICES LIST................................ ................................ ..............14

9. CHANGE PARTS ................................ ................................ ................................ ....................... 15

10. CLEANING PROCEDURES ................................ ................................ ................................ .......15

10.1.

10.2. Cleaning Records ................................ ................................ ................................ ............... 15

11. PREVENTATIVE MAINTENANCE ................................ ................................ .............................. 15

11.1. Preventative Maintenance Program Identification: ................................ .............................. 15

12. TRAINING RECORDS ................................ ................................ ................................ ................ 16

13. ................................ ................................ ................................ ..16

13.1. Equipment Operation................................ ................................ ................................ .......... 16

13.2. Process Operation................................ ................................ ................................ ..............16

14. DISCREPANCIES................................ ................................ ................................ ....................... 16

15. SIGNATURE LOG ................................ ................................ ................................ ...................... 17

16. ATTACHMENTS ................................ ................................ ................................ ......................... 17

TEM 170 Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

1. OBJECTIVE

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2. ACCEPTANCE CRITERIA

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3. QUALIFICATION PROCEDURES

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As Built drawings and equipment specification as quoted in the protocol.

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Prepared by: Date Prepared: Revision No: Page

of 17

Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

  1. Piping
  2. Pneumatic
Drawing ID Rev. No. Description Location As Built Verified Date Verified by
Yes No
























































Drawing ID Rev. No. Description Location As Built Verified Date Verified by
Yes No
























































  1. List of Supplier Quotes & Purchase Orders for Major Components
  2. List of Equipment / Maintenance Manuals.
Component Supplier Quote Purchase Order No. Location




























Manual ID. Location










Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

6.2.2. Component Listing

Component Parts Material of Construction
Specified Actual



























6.3. Component Materials (as detailed in design spec.) not in Product Contact

Component Parts Material of Construction
Specified Actual



























6.4. Filters: This list is based on information from purchase orders and eq uipment specifications. Verify that the items have been delivered as specified

Identifying No: Size/Porosity (Micron) Location Verified Verified by



Yes No






















































Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

6.7. Spare Parts List Location:

Mechanical: Attach material/component list (attachment)

6.8. Can machine adjustment be made without potential for product contamination ? YES / NO

Write a brief description as to how machine adjustment can be done to no t effect product quality. Include any follow up activities that must occur after machine adjustment .

7. ELECTRICAL INSTALLATION

Complete a list of drawings & manuals associated with the electrical installation of the equipment /system.

Document Location of the latest versions. Verify the accuracy of those drawings which represent the system

7.1. Electrical Drawings

  1. Single Line
  2. Cables Schedules
Drawing ID Rev. No. Description Location As Built Verified Date Verified by
Yes No
























































Drawing ID Rev. No. Description Location As Built Verified Date Verified by
Yes No

























































TEM 170

Issue date
Installation Qualification for Equipment
(Reference SOP: _________)
7.4. Distribution Details
Main Switchboard:
Sub Board:
Distribution Board:
Circuit Breaker Type:
Circuit Breaker Rating:
Phases:

7.5. Instrumentation

Attach all items requiring calibration. Attach calibration reports for all critical items and non critical items requiring calibration .

  1. Critical Instrumentation
  2. Non Critical Instrumentation (Convenience)
Description Manufacturer Model No. Serial No. Equipment No Previous Maintenance No.


























































































Description Manufacturer Model No. Serial No. Equipment No Previous Maintenance No.






























Installation Qualification for Equipment

(Reference SOP: _________)

TEM 170 Issue date

Item Requirement Details/Function Sign/Date
PC Name of manufacturer Record model number Record serial number

Operating system Record type of Record version of

System configuration files Record details.(Include printout if available)

Inspection Visually inspect and confirm that unit is in good condition

Logon Confirm able to logon to PC and successfully able to call up any critical programs from desktop.

PLC s, PC s, LAN etc.

7.7.3. Computerised System Inventory List

To section should be filled out and submitted to ensure that the site Computerised System Inventory List is maintained as procedure

Information Equipment
Equipment Equipment
Proposed SAP Equipment No (EO# etc)



Description (40 char. max.)



Long Text (If needed)



Vendor



Acquisition date



Manufacturer



Manufacture Country



Construction Year



Construction. Month



Model No



Manufacturers Part No



Manufacturers Serial No



Superior Equipment



Functional Location



Technical Identification No



Submitted by
Sign
Date

Issue date

Installation Qualification for Equipment

(Reference SOP: _________)

9. CHANGE PARTS

List below all change parts, quantity, and description for each process requiring a changeover .

Item Description Quantity Specification Part No. ID No. on equipment
























10. CLEANING PROCEDURES

10.1.

system. Ensure you reference the current version.

S.O.P. No: Title Date Issued












10.2. Cleaning Records

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






2 comments:

swagatika mahalik said...


Software validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation.more information

sandip said...

In the past equipment suppliers have often been delinquent in supplying the right scope and quality of support documentation for their products. As a consequence end user companies have not always had sufficient information (especially in the form of engineering drawings and specifications) about the equipment they have purchased, to develop and put into place the quality of documentation that regulatory requirements demand. For correct and trouble free qualification it is really essential that the scope and quality of the proposed equipment documentation; is specified at the equipment procurement stage.
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