MPR-PPC-WI-009098, Revision 32.XPage 1 of 17

Installation Qualification (IQ)

Quality System Element / Production and Process Controls
Scope / All equipment used in the manufacturing, test,and inspection of components, subassemblies, assemblies and products intended for commercial release by MPROC, or to control environmental conditions of manufacturing areas.
Qualification of utilities and facilities may also follow requirements in this work instruction.
For Category 3 (GAMP) stand-alone software packages, and equipment with Category 4 and 5 software, refer to MPR-PPC-WI-009167.
Purpose / This work instruction provides details for executing an Installation Qualification as part of the Manufacturing Process Validation lifecycle. Refer to MPR-PPC-PP-009099 for general and higher level requirements.
Reference Documents / MPR-PPC-PP-009099 – Manufacturing Process Validation
MPR-PPC-WI-009167 – Computerized System Validation Lifecycle
MPR-PPC-PP-009028 – Equipment Lifecycle
MPR-PPC-PP-009113 – Equipment Maintenance Activities
Groups or Functions Impacted / Manufacturing Engineering
Quality Engineering
New Product or Technology Transfer Engineering
Records and Maintenance
Record Description / Start of Retention Period / Record Code1
N/AMPR-PPC-FRM-009233 / N/ADate of approval / N/APRD4320
MPR-PPC-FRM-009385 / Date of approval / PRD4320
1See Corporate Retention Schedule for record code definitions and length of time to retain the record.
  1. Change Information

Reason for Change / Administrative change.Process Improvement
Background / Why is Required / Corrections, improvements and clarifications were identified during the QIP Process Validation Control PhaseReferences and additional subsection in section C deleted. Additional section is not required as per MPR-DOC-WI-8987.
Description of Change / Upper left header deleted on page 1. Revision number corrected in headers on page 2 and onward. Subsection “1.0 Procedure Matrix” in section C, deleted.E,3.0 – Gather and Evaluate Inputs
(a)3.1 - Add establishing requalification conditions as a deliverable for which gathering IQ inputs is crucial.
E,4.0 – Determine IQ Requirements
(b)Tables 3 - 6 – Updated examples.
(c)Table 2 – Added guidelines for sourcing and controls of manufacturing aides.
(d)Table 3 – Added clarification regarding “calibration” to include “certification” of non-adjustable instruments.
(e)Table 4 – Clarified plan/report requirements for Type II equipment.
(f)Table 5 – Clarified equipment suppliers may be internal or external. Added Tornos Deco 20a as an example (moved from Table 6)
(g)Table 6 – Added note to allow use of Type III IQ template on certain Type IV equipment. Removed Tornos Deco 20a as an example.
E,6.0 – IQ Plan
(h)6.2.3 – Added Functional Verification requirements to consider fault conditions and defects (negative testing), and equipment interface with MES.
E,10.0 – Change Management and Requalification
(i)10.2.2 – Clarified requalification requirements for spare parts deemed as critical.
B, Definitions and Acronyms
(j)Added MES and its definition.
E,3.0 – Gather and Evaluate IQ Inputs
(k)3.2 – Added Table Title
Records and Maintenance
(l)Added MPR-PPC-FRM-009233 and MPR-PPC-FRM-009385
Justification for Change / Changes were identified during the Control Phase and reviewed by the QIP Process Validation team.To comply with format established in MPR-DOC-TMP-008418 andguidelines defined in and MPR-DOC-WI-008987.
Process Section Affected / Sections: See Description of Changes aboveRecords and Maintenance, B, E (3.0, 4.0, 6.0 and 10.0) Section C
  1. Definitions, Abbreviations, and Acronyms

Term / Definition / Description
* / Refer to Global Policy 003 – Manufacturing Process Validation for general definitions (
Calibration / Demonstrating that a measuring device produces results within specific limits by a reference standard device over an appropriate range of measurements.
CSV / Computerized Systems/Software Validation
Equipment Event / Recorded instances of equipment intervention for the purposes of calibration, preventive maintenance, servicing, modifications and repairs. Equipment Events are tied to specific Equipment Records. Equipment Events are tracked in Equipment Support systems such as Indysoft.
Equipment Record / Compilation of equipment-specific documentation and servicing history. Equipment records are maintained for individual equipment or multiple pieces of equipment under an equipment design.
Manufacturing Aide / Standard supplied items and tools used to manipulate product or assist in manufacturing operations. Examples of manufacturing aides include tweezers, pliers, wrenches, syringes, scalpels, standard carrier bases, wipes, etc.
MES / Manufacturing Execution System
OEM / Original Equipment Manufacturer
Scheduled Equipment Activity / Calibration, maintenance or servicing activities with frequency or instance established as part of equipment IQ, and documented in a released controlled procedure.
Unscheduled Equipment Activity / Calibration, maintenance or servicing activities, or modifications to equipment that were not established as part of equipment IQ, and whose impact on existing IQ needs to be assessed.
OEM / Original Equipment Manufacturer

C.Process Flowchart

1.0Process Flow


  1. Responsibility

Role / Responsibility
* / *

*Refer to MPR-PPC-PP-009099, Manufacturing Process Validation for Roles and Responsibilities.

E.Instructions

1.0Introduction

1.1These instructions are organized by major activity blocks as depicted in the Process Flow section. The process flow assumes equipment is either new, or transferred from another facility.

1.2Refer to MPR-PPC-PP-009099, Manufacturing Process Validation for an overview of the entire manufacturing process validation lifecycle, and applicable requirements across validation elements.

1.3Refer to MPR-PPC-JTS-009361for applicable site governing procedures and forms that support IQ activities.

1.4Installation qualification of Type IV equipment (configurable/custom computerized systems) is addressed byMPR-PPC-WI-009167, Computerized Systems/Software Validation. See Section 4 belowfor equipment types.

1.5Manufacturing aides do not require Installation Qualification activities. Follow governing Production & Process Controls and Purchasing Controls procedures for ordering, receiving and handling manufacturing aides.

2.0Equipment Registration and Identification

2.1All new manufacturing equipment or major components of a manufacturing system must be registered in Gage InSite and identified with a unique identifier for equipment support purposes. Refer to MPR-PPC-PP-009113, Equipment Maintenance Activities.

2.2Equipment must be identified with applicable Equipment Status Tag until all qualification activities are complete.

3.0Gather and Evaluate IQ Inputs

3.1IQ inputs are used to develop the IQ Plan. Gathering and evaluating IQ inputs is a crucial step to:

  • properly categorize equipment type,
  • identify or create required documentation to sustain equipment,and
  • define adequate testing of equipment installation, safety, function and performance, and
  • establish conditions that require requalification

3.2The following are typical IQ input examples:

Table 1: Typical IQ inputs

Input / Description / Document / Status
Process Risk Assessment (recommended) / Identifies process and equipment risks and identifies mitigations /
  • PFMEA
/
  • Draft

Functional and Performance Requirements / Functions and outputs that could affect process capability and product conformance to specifications /
  • Process operating description
/
  • Draft (new), Controlled (existing)

  • Manufacturer’s Documentation
/
  • Controlled

  • Similar equipment validations
/
  • Approved

Installation/Operation Conditions / Specifications for proper equipment operation /
  • Manufacturer’s Documentation
/
  • Controlled

  • Drawings & schematics
/
  • Controlled

Spare parts list / Recommended spare components and specifications for continuous operation /
  • Manufacturer’s Documentation
/
  • Controlled

  • Equipment history
/
  • Gage Insite

Sustaining requirements / Calibration, maintenance and repair procedures for sustained operation /
  • Calibration, Maintenance or Setup procedures
/
  • Controlled

EHS Requirements / Attributes and functions to protect the environment, health and safety of users /
  • Equipment EHS Assessment Form
/
  • Controlled

4.0Determine IQ Requirements

4.1The extent of equipment IQ activities is proportional to the complexity and risk of the equipment. Equipment may be classified in one of the following types:

Table 2: Manufacturing Aides Guidelines

Type / Characteristics / Examples
Manufacuturing Aide /
  • Standard supplied items and tools used to manipulate product or assist in manufacturing operations
  • These might be supplied externally, or by another Medtronic facility, and subject to Incoming Inspection or Purchasing controls.
/
  • Tweezers
  • Allen wrenches
  • Pliers
  • Scalpel
  • Delrin probe
  • Standard carrier base

IQ is not required. Refer to governing Production & Process Control and Purchasing Control procedures.

Table 3: Type I Equipment Guidelines

Type / Characteristics / Examples
I – Standard/Calibrated Instruments /
  • Stand-alone functional unit
  • Does not affect form, fit or function; typically used for verification or inspection activities.
  • Calibration* is the only requirement to meet intended use
  • No utility connections are required or only requires a standard 120V/60Hz power source(instrument is not sensitive to voltage fluctuations)
  • No requirements for equipment leveling
  • Firmware is embedded (black box) and cannot be adjusted or configured differently across products
/
  • Micrometers
  • Calipers
  • Ruler
  • Go/NoGo Gage Pinss
  • Ionizer
  • Microscope
  • Multimeter
  • Scale
  • Oscilloscope
  • Temperature/humidity chart recorders
  • Templates, overlays

For Type I equipment, the IQ consists of equipment calibration per a released calibration procedure and documented as an equipment event in the equipment record. IQ plan and report are not required.

* Calibration also refers to certification of instruments whose outputs/attributes are not adjustable (e.g. rulers, gage pins).

Table 4: Type II Equipment Guidelines

Type / Characteristics / Examples
II – Custom Tooling & Fixtures /
  • Typically used on a workbench, or as part of a larger piece of equipment
  • Dimensional and construct/assembly specifications are typicallydefined by a mechanical drawing
  • Initial verification of functionality or conformance to print assures fit for its application
  • May require periodic maintenance for sustained performance
/
  • Custom fixtures
  • Cutting fixtures
  • Welding fixtures
  • Molds & Dies
  • Pin blocks
  • Carrier insert
  • Product Label Printer
  • EFD Manual Dispensers

For Type II equipment, the IQ consists of an initial verification of functionality and/or conformance to critical equipment dimensional specifications or attributes. If calibration and/or preventive maintenance are required, the equipment must undergo such processes per released procedures and documented as an equipment event in the equipment record. A plan is not required, only completion of the Equipment Verification Form (refer to Section 5.0).

Table 5: Type III Equipment Guidelines

Type / Characteristics / Examples
III – Standard Equipment /
  • Requires utility connections other than standard 120V/60Hz power source, or sensitive to voltage fluctuations
  • May require calibration and/or preventive maintenance.
  • May require leveling
  • Fully functional as offered by internal or external supplier, with none or minor modifications
Equipment with simplefirmware, COTS, or standard software package for which configuration is limited to establishing the run time environment of the equipment (software GAMP category 3 per 009167) /
  • Resistance Welder Power Supply
  • Resistance Welder Head & Head Controller
  • Ultrasonic Welder
  • Instron, Chatillon pull testers
  • EFD & I&J Automatic Dispensers (e.g. EFD Ultra TT, I&J Fisnar)
  • Ultrasonic Cleaners
  • Pouch Sealer, Blister Sealer
  • Pressure Decay/LeakTester
  • Ovens
  • Tornos Deco 20a CNC Swiss Lathe
  • PLC-controlled Dry Boxes

For Type III equipment, the IQ must be established in a plan, and closed in a report. Software/firmware component qualification, if applicable, is met through functional verification in the IQ. If calibration and/or preventive maintenance are required, the equipment must undergo such processes per released procedures and documented as an equipment event in the equipment record prior to conducting functional and/or performance verification testing in the IQ.

Table 6: Type IV Equipment Guidelines

Type / Characteristics / Examples
IV – Configurable and Custom Equipment /
  • Requires utility connections other than simple power source, or sensitive to voltage fluctuations
  • May require calibration and/or preventive maintenance
  • May require leveling
  • Custom designed for Medtronic’s applicaton, or Type III equipment with major modifications
  • Contains custom software (GAMP 4 & 5)
/
  • Custom Automated, Computerized Systems
  • Custom Laser Welder
  • Swiss-type CNC latheIndex CNC Mill-Turn Center G200
  • Tornos TB-Deco Software
  • HPLC Systems
  • HVAC Control Systems
  • RAM, TAM, PAD (Reservoirs)
  • Basal Controller

Type IV equipment requires CSV. Follow MPR-PPC-WI-009167 for qualification of Type IV equipment.
Note: Validation of custom equipment may be performed following Type III documentation provided configuration is limited to run time parameters (e.g. pressure, temperature) and software backup/restore is not applicable.

5.0Equipment Verification (Type II Equipment Only)

5.1This section applies to Type II equipment, as defined above. Use formMPR-PPC-FRM-009385to document Equipment Verification.

5.2Equipment Verification consists of two types of test, as applicable:

5.2.1Dimensional/Attribute Verification test

  • This test is intended to confirm that critical equipment dimensionsor attributes (e.g. materials, coatings) meet drawing specifications.
  • The process/equipment owner defines critical dimensions/attributes for the intended application, if they are not specified in the drawing.
  1. Functional Verification test
  2. This test is intended to confirm that equipment meets functionality requirements for the process or equipment it is used on. Functionality examples include movement, mating, or holding.
  3. The process/equipment owner defines functional requirements to be tested and provides detailed test instructions.
  1. Dimensional and/or functional verification might be fulfilled with certification from vendor when such equipment is supplied externally. Vendor certification must be attached to Equipment Verification form.
  2. A section is provided for the qualification of Product Label Printers within the Equipment Verification form.

6.0IQ Plan

6.1This section applies to Type III equipment, as defined above. Use form MPR-PPC-FRM-009233to generate the IQ Plan.

6.2The IQ plan covers the following test stages, which must be conducted in the order listed:

6.2.1Documentation and Installation Verification

  • Confirmation of the equipment configuration being qualified, proper equipment identification and controlled equipment documentation.
  • Confirmation that all required utilityconnections and environmental conditions meet equipment specifications, equipment starts up as expected, calibration and maintenance procedures are established, spare parts are identified and ordered, and procedures exist for equipment operation.
  1. EHS Assessment and Safety Functions Verification
  2. Confirmation that equipment meets applicable EHS requirements, safety features and alarms work adequately, and all cautionary labels are in place.
  3. Functional Verification
  4. Confirmation that all equipment functions (e.g. screens, actuation, indicators) perform as expected, i.e. the equipment does what it is supposed to do, when it is supposed to do it.
  5. Where applicable, negative testing must be conducted to challenge equipment capability to detect fault conditions or defects (e.g. incorrect fixture used; operators cannot access equipment parameters).
  6. For equipment that interfaces with the MES (e.g. Factory Works), functional verification should be conducted such that the interface and information exchange between equipment and MES is challenged, including fault conditions.

6.2.4

6.2.4Performance Verification

  • Confirmation that equipment performance is repeatable under anticipated conditions and range of operation. A minimum of ten (10) replicates at each condition tested are required to demonstrate repeatability.
  • Anticipated conditions refer not only to equipment parameters, but also environmental and operational conditions (e.g. simultaneous loading, shared facilities, frequency of use, etc).
  1. A single IQ Plan may combine multiple pieces of equipment of the same model, provided all test requirements are appliedindividually and documentation clearly tied to an individual piece of equipment.
  2. Refer to MPR-PPC-PP-009099 for general, documentation and approval requirements.

7.0IQ Execution

7.1Execute and document all tests following an approved plan.

7.2Equipment must be calibrated and maintenance activitieskept current per released procedures before conducting Functional Verification or Performance Verification. Refer to MPR-PPC-PP-009113, Equipment Maintenance Activities

7.3Refer to MPR-PPC-PP-009099 for general, documentation and data collection requirements, and for handling deviations.

8.0IQ Report

8.1Use formMPR-PPC-FRM-009233to generate the IQ Report.

8.2Refer to MPR-PPC-PP-009099 for general, documentation and approval requirements.

8.3Once the IQ Report is approved, subsequent validation activities (TMQ, OQ Run, PQ) or production may proceed as applicable.

9.0Sustain & Monitor Equipment

9.1Once Equipment IQ is complete, the qualified state is maintained through scheduledand unscheduled equipment activities, or as part of verification activities established in equipment operating procedures.

9.2Refer to MPR-PPC-PP-009113 for managing equipment activities.

10.0Change Management and Requalification

10.1Unscheduled equipment activities such as maintenance, servicing, modification or repair must be assessed to determine whether they impact the qualified state of the equipment.Unscheduled activities usually arise as a result of equipment alarms, malfunction, improvement or relocation.

10.2The following are typical unscheduled activity scenarios:

10.2.1Minor Replacement and Service parts (like-for-like)

  • These are simple stand-alone mechanical or electrical components or non-critical spare parts such as filters, actuators, valves, sensors or circuitry, often provided by third-party vendors via catalog or through an OEM.
  • Like-for-like includes equivalent service parts with the same specifications and function as original parts.
  • Replacement/repair activities can be easily conducted, typically in a relatively short period of time, and require none or minimal troubleshooting.
  • Equipment functionality can be easily confirmed through verification of equipment output (e.g. motion, activation, readings).
  • Requalification is not required. The replacement activity and corresponding equipment verification is documented as an equipment event in the equipment record.
  1. Major Replacement/repairs
  2. These often involve disassembling equipment, or repair/replacement of critical spare parts such asmajor or multiple functional components, subsystems or software in critical or highly sensitive equipment functions. Spare parts designated as critical require equipment requalification when replaced.
  3. Replacement/repair activities typically take a moderate to considerable period of time to conduct, and may require iterative or complex troubleshooting.
  4. Requalification is required for certain IQ aspects that might have been impacted by the repair/replacement activity.
  5. Modifications or Additions
  6. These include upgrading or improving validated hardware/software, or incorporating new hardware/software to add equipment functions.
  7. Requalification is required for all upgraded or new functions, or functions which interface and could be indirectly affected.
  8. Relocation
  9. All equipment moves which result in equipment displacement from its original location, new utility connectionsor reconnections (unless quick-connects to same utility line) must be considered relocation.
  10. Relocation does not include transfers from plant to plant, i.e. equipment leaves a Medtronic facility. Equipment transfers require a full IQ.
  11. Requalification is required for all relocations, unless equipment is deemed Movable, as described below:
  12. Portable design (e.g. sturdy construction, rollers in frame)
  13. There are no utility connections, other than simple power source (120V/60Hz)or equipment is installed onto a qualified fixed station.
  14. Equipment does not require disassembly as part of the relocation process.
  15. None of the safety features of the equipment (e.g. guards, light curtains) are removed or changed as part of relocation.
  16. Equipment calibration or functions are not sensitive to alignment, imbalance, vibration or certain environmental conditions.
  17. The determination to deem equipment Movable is documented in the IQ Report.

10.2.5Prolonged Shutdown