Document Detail - Stryker Corporation · Product Lifecycle Management (PLM) system. A device software set contains one version of the Operating System Software for a specific Physio

PHYSIO-CONTROL

11811 WILLOWS ROAD NE - POST OFFICE BOX 97006

REDMOND

WASHINGTON

6/16/2018

1

Document Detail

Type: QUALITY SYSTEM DOCS

7000180[T]Document No.:

SERVICING PROCESS WORK INSTRUCTIONTitle:

SALAZJ1 Juan SalazarOwner/Modifier:

CURRENTStatus:

Effective Date: 16-Jun-2020View Expiration Date:16-Jun-2018

Document Build

No.

Access Activity Accessed By Accessed Date

Revision Notes

1 Check In 16-May-2018SALAZJ1

Note:

2 Check In 17-May-2018HOWEA1

Note: fix formatting, add training role to change description


Note: fix page breaks

4 Check In 21-May-2018SALAZJ1

Note:


Note: fix formatting

6 Check In 11-Jun-2018HOWEA1

Note: clerical corrections: updated title of 7M14 in sections 3 and 15

6/16/2018

2

Document Detail

Review

APPROVAL

Review Purpose: Initial document review and approval.

Review:

Build No.: 4 Closed Date: 5/22/2018 2:31:06PM

Review Note: SYSTEM AUTO CLOSE REVIEW

Sign-off ByActorOwner RoleLevel Sign-off Date

HOWEA1HOWEA1 Andrea HoweDOCUMENT CONTROL

DOCUMENT CONTROL

0 21-May-2018 8:26 pm

Note To Approver:

Note From Approver:Quality check complete

SALAZJ1SALAZJ1 Juan SalazarQS PROCESS OWNER QS

PROCESS OWNER

1 21-May-2018 8:31 pm

Note To Approver:

Note From Approver:Approved

SALAZJ1SALAZJ1 Juan SalazarQS SYSTEM OWNER QS SYSTEM

OWNER

1 21-May-2018 8:32 pm

Note To Approver:

Note From Approver:Approved

KDASHENKDASHEN Kim DashenQUALITY SYSTEM MANAGER

QUALITY SYSTEM MANAGER

1 22-May-2018 2:31 pm

Note To Approver:

Note From Approver:This is approved.

BELLC1BELLC1 Casey BellTRAINING PROCESS OWNER

TRAINING PROCESS OWNER

1 21-May-2018 8:46 pm

Note To Approver:

Note From Approver:Approved.

HUBERD2HUBERD2 DAVID HUBERDOCUMENT APPROVER

DOCUMENT APPROVER

1 21-May-2018 10:15 pm

Note To Approver:

Note From Approver:Reviewed and approved

Title SERVICING PROCESS WORK INSTRUCTION Page Page 1 of 18

Doc Type QUALITY SYSTEM DOCS

Process Owner SALAZJ1 Doc # 7000180

Doc State CURRENT Effective Date 6/16/2018 Doc Rev T

QS System Service Provision QS Process Field Service Depot Aftermarket

QS Parent 7000022, Servicing Quality Procedure

Confidential – Stryker Proprietary Information – Do Not Duplicate

Quality Work Instruction Template: 8000862_B PRINTED COPIES ARE UNCONTROLLED AND FOR REFERENCE ONLY

This document is electronically signed. Approvals can be obtained from the system which displays the selected approvers, their approval roles, and approval dates.

PROPRIETARY AND CONFIDENTIAL DOCUMENT FOR PHYSIO-CONTROL, INC. USE ONLY. This document is property of Physio-Control and may not be used, reproduced, published or disclosed to others without authorization from Physio-Control.

Change Description

Re-write in support of ISO 13485:2016 and MDSAP initiatives. See Redlines for additional document changes. Changes are forward looking for the implementation of ISO 13485:2016 and MDSAP and are adding requirements and definitions for going forward and a future state. Retrospective review is not required. Change is effective on the release of this work instruction. The following roles have been added at this revision: TR_ALL SERVICE All roles that are assigned training for this document are required to complete read and understand training on this revision.

Revision History

CO Revision Reason for Change

CH000789 S Updated to new template, revised references, and added requirements to address CAPA-000235

CH000821 T Updates for ISO 13485:2016 and MDSAP









PURPOSE

This document establishes the standard methods and processes used to service Physio-Control, now a part of Stryker (Physio), medical devices.

SCOPE

This procedure applies to Physio service representatives and service providers unless specifically excluded.

INTERNAL REFERENCES

Document Number

Title

3206073 Instructions for Use, Combined Service Configurator - Loader

7000014 Handling, Storage, and Distribution Quality Procedure

7000018 Inspection, Measuring, Test and Process Equipment Quality Procedure

7000022 Servicing Quality Procedure

7000024 Device Tracking Quality Procedure

7000100 Contamination and Infection Control Work Instruction

7000131 Supplier Selection Work Instruction

7000145 Electrostatic Discharge Work Instruction

7000155 Calibration Program Work Instruction

7000175 Maintenance, Control and Retention of Records Work Instruction

7000360 Scrap Control Work Instruction

7000648 Product Issue Reporting Form

7000717 Evaluation, Loaner, and Demonstration Work Instruction

7000763 Refurbished (RELI), ACLS (trainer), and Parts Salvage Quality Procedure

7000778 Device scrap notification form

7000821 Product Issue Tracking Work Instruction

7000866 Failure Analysis Center Work Instruction

8000006 Corrective and Preventive Action Quality Procedure

8000007 Complaints Quality Procedure

8000087 Complaint Handling Work Instruction

8000089 Product Hold Work Instruction

CQM-02 Stryker Corporation Quality and Regulatory Master Glossary

PC000220 Device Compliance Tool Business Process

PC000222 Technical Bulletin_ServiceMax Documentation Guide

PC000226 TB_LP12,LP15,LP20/20e,LP500,LP1000,CR PLUS,LUCAS_Software









DEFINITIONS, TERMS, AND ACRONYMS

Term Acronym Definition

Advanced Cardiac Life Support Device

ACLS

This is a device that has been previously distributed to a customer, or used in the Evaluation or Loaner pools, returned to Physio inventory and has been converted to a non-clinical Advanced Cardiac Life Support (ACLS) status for distribution as a trainer. The business may choose to use a new device to meet the needs for an ACLS device. Reference 7000763

Bloodborne Pathogens N/A Microorganisms that are present in human blood and can cause diseases in humans. These pathogens include, but are not limited to, Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV). Reference 7000100

Case N/A A record documenting a customer’s feedback, problem, or question

Combined Service Configurator/Loader

CSCL Utility required to load device software and configure device settings.

Complaint N/A

Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a Stryker device after it is released for distribution by a manufacturing site.

Reference 8000007

Device Compliance Tool DCT Utility used to verify the configuration of a device, launch the computer assisted product inspection procedure, and record device data.

Distributors N/A

A non-Stryker organization or entity that sells or introduces a product or service into commerce. The distributor is not involved in manufacturing process that changes the form, fit, or function of the product.

Reference CQM-02

Failure Analysis Center FAC

Group that analyzes/troubleshoots and manages the inventory of all material that is returned with a reported problem.

Reference 7000866

Finished Medical Device N/A

Means any device, or accessory to any device, that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Reference CQM-02

Manufacturing Configuration

N/A Factory settings within the device configured and controlled by Physio and the variant spec of the device.










Medical Device N/A

Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination (i.e., medical device system), for human beings for one or more of the specific purpose(s) of (1) diagnosis, prevention, monitoring, treatment, or alleviation of disease, (2) diagnosis, monitoring, treatment, alleviation of or compensation for an injury, (3) investigation, replacement, modification, or support of the anatomy or of a physiological process, (4) supporting or sustaining life, (5) control of contraception, (6) disinfection of medical devices, (7) providing information for medical purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.

Reference CQM-02

New Product Evaluation NPE Optional evaluation plan for new product introductions to help facilitate enhanced root cause understanding and rapid correction of potential product performance issues during initial product manufacturing and distribution.

Non-Redmond Partner Warehouse

NRPW A physical location that manages the storage and distribution of products on behalf of Physio.

Reference 7000360

Other Potential Infectious Materials

OPIM Potential infectious material including but not limited to human body fluids or tissue.

Reference 7000100

Operating System Software

N/A A specially created set of device software files released into the Product Lifecycle Management (PLM) system. A device software set contains one version of the Operating System Software for a specific Physio device. Multiple device software sets may be distributed on CD or through an IT laptop application package.

Patient Data N/A

Information unique to an individual patient or unique to that patient’s treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device. This information may include, but is not limited to, recorded patient data, device usage/output statistics, healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures.

Performance Inspection Procedure

PIP A set of test procedures used for an operational evaluation of a device.

Product Hold Order PHO A quality record that authorizes Physio to identify, segregate, quarantine, and disposition nonconforming product.

Reference 8000089










Refurbish N/A

The process used to repair, upgrade, reconfigure, and test a device for distribution as RELI, ACLS. The device components and subassemblies are the original material used when it was manufactured plus any new items installed to support repair, upgrade, or reconfiguration. The acceptance tests are the service Performance Inspection Procedure (PIP) or the supplier’s recommended tests.

Reference 7000763

RELI Device RELI

This is a device that has been previously distributed to a customer, or used in the Evaluation or Loaner pools, returned to Physio inventory and has been refurbished and converted to a “Used” status for distribution as a “RELI” device. The business may choose to use a new device to meet the needs for a RELI device. Rely is an acronym for “Refurbished Equipment from the Lifesaving Innovators.”

Reference 7000763

Service Manual N/A

Service manuals convey customer-facing information. Examples are safety, maintenance schedules, and specifications. Additionally, for service representative and biomedical trained support staff, repair information. For example: troubleshooting, assembly/disassembly processes - which are compiled from validated manufacturing PWIs, and parts lists.

Service Process Work Instruction

PWI Service PWIs convey detailed repair processes utilizing validated manufacturing procedures compiled into a single document.

Service Provider N/A

A supplier that provides a service to Physio. Service providers do not supply physical materials, parts, components, or products. Reference 7000131

Service Representative N/A Team members or contractors that perform or provide technical support or service.

Setup Options N/A User configurable setup options within the device that remain even on power cycling of the device.

Technical Bulletin TB

Technical Bulletins convey business information and Technical information (Tech Tips) to the domestic and international Physio Service Team. Technical Bulletins may contain general or product-specific information that augments or clarifies some aspect of Physio Service Team operations.

Technical Service Update TSU A TSU is used to modify or inspect product in distribution in support of field actions. They provide specific, detailed instructions to Physio Service Teams to conduct field repairs, product updates, product inspections, or custom installation for a specific device population as required for Regulatory action, Business action, Quality Improvement Updates, Product Hold (PHO) dispositioned product, or for Clinical trials.










Update N/A A hardware or software update that brings a device up to a new revision but does not include new functions or features.

Upgrade N/A A hardware or software update that includes new functions or features.

User Settings N/A User configurable settings that are temporary and cleared on power cycling of the device.

Work Order N/A a record of service activity including but not limited to; case resolution, problem resolution, and preventative maintenance.

ROLES AND RESPONSIBILITIES

Roles Responsibilities

Customer A person or company who purchases a medical device.

Distributor A non-Stryker organization or entity that sells or introduces a product or service into commerce. The distributor is not involved in manufacturing process that changes the form, fit, or function of the product.

Device Tracking Coordinator (DTC)

A role responsible for administrating and updating the Installed Base.

Direct and Indirect Service Resources

Ensure compliance to this procedure.

End User Person or company outside of the Physio organization to whom the product has been delivered and who, to the best of our knowledge, ultimately takes possession of the Serialized Finished Device.

Service Operations Responsible for the creation, validation, and implementation of service support documentation.









PROCESS FLOW

Servicing Process Work Instruction

Tri

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erv

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ep

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tive

Activity

Customer contacts Physio-Control for

service or support:

- Direct customer contact

- Dispatch request from technical support

- General request

Initiate service record as required

Sec. 7

Provide Support as required

If a complaint has not already been captured in the service record,

initiate a complaint.Sec. 8

Notify device tracking if the

device s location has changed.

Sec. 9

Decontaminate the device as required.

Sec. 10.4

Verify equipment calibration as

required.Sec. 10.3

Is this in person service (onsite or in depot) or

support, or over the phone/email?

Perform service as required to the

device using required processes

or procedures.Sec. 12

Does any material need to be collected and

returned for further analysis?

Return material as required.

Sec. 15.2.1

Complete service recordSec. 7

Phone/Email

In Person

Yes

Scrap material

SERVICE RECORDS

A service record describes a service activity performed on a Physio medical device. Service records are entered into a computer system database or are a paper record. The service record is a document designed to allow standard processing of all service related information.

Service representatives are required to document detailed information in the service record regarding all servicing activities.

Service providers shall have established service record management processes that meet the established processes for their organization. Converted physical records shall comply with the Maintenance, Control and Retention of Records Work Instruction 7000175 (reference section on conversion of physical records to electronic records).









7.1 Information Required in a Service Record

7.1.1 Name or model of the device being serviced

Service records shall include the model number or name of the device being serviced.

7.1.2 Device Identification(s)

Service records shall include the following device identification(s)

Serial Number of the device being serviced

If exists, the Unique Device Identifier (UDI) of the device being serviced US UDI Requirements: Service representatives and service providers shall check for whether the finished device or accessory is labeled with a UDI. If the device has a UDI label, it shall be scanned or entered on the case or work order. See UDI label examples below. Outside the US UDI Requirements: Service representatives and service providers outside of the US shall follow local requirements for the capture and documentation of the UDI. See UDI label examples below.

7.1.3 Individual Servicing the Device

Service records shall include the name of the person servicing the device.

7.1.4 Service Performed

Service records shall include a summary of the service performed.

7.1.5 Test and Inspection Data

Service records shall include the following test and inspection data.

Performance Inspection Procedure results

Data Download and Configuration Assurance









7.1.5.1 Performance Inspection Procedure Results

Any time a medical device is given to a service representative or service provider for a service activity, a performance inspection shall be performed before the device is returned to the customer to assure the device is in working order. Exceptions: A PIP is not required for the following service activity

Software update or upgrade that is being performed using a LIFENET System product

Performing a software update only under the direction of a TSU where functionality can be confirmed by the TSU or tools provided as part of the TSU.

Customer declines a billable repair.

7.1.5.2 Computer Assisted Performance Inspection Procedure (CAPIP)

Where available, a CAPIP may be used to perform the inspection and testing of a device. CAPIP results shall be attached to the service record. In the case that the CAPIP isn’t available, or the person is unable to perform or attach the results to the service record, a manual PIP shall be performed and the results shall be attached to a service record.

7.1.5.3 Manual Performance Inspection Procedure

Manual Performance Inspection procedure is used where a CAPIP is not available. Service representatives and service providers shall perform the PIP and document the results on the forms. The forms shall be attached to a service record. Converted physical records shall comply with the Maintenance, Control and Retention of Records Work Instruction 7000175 (reference section on conversion of physical records to electronic records).

COMPLAINT REPORTING

Service representatives and service providers shall report to the Product Complaints Department when they become aware of any information that meets the definition of a complaint for a medical device manufactured or distributed by Physio per 8000007 Complaints Quality Procedure. This includes but is not limited to Physio devices (ex. LP12 or LP15), accessories (ex. SPO2 cables), and distributed devices (ex. Lucas and Laryngoscope). Service representative’s cases and work orders within Salesforce are considered complaints as specified per 8000007 Complaints Quality Procedure and do not require any additional notification to the complaints department. Service representatives and service providers who do not log cases and work orders in Salesforce shall submit a Product Issue Reporting form as required per 8000007 Complaints Quality Procedure. If a service representative or service provider receives a complaint that is not documented within a case or work order, the person shall inform the complaints group of the complaint as required within 8000007 Complaints Quality Procedure.

DEVICE TRACKING UPDATES

Service representatives and service providers shall update a device’s location when made aware of a change to the end-users location, or address, by following the Device Tracking Quality Procedure 7000024.









US service representatives may make changes by following the instructions within the Technical Bulletin ServiceMax Documentation Guide PC000222. When scrapping a customer owned device at a NRPW, service representatives shall complete the process per the Scrap Control Work Instruction 7000360.

SERVICE PERSONNEL

10.1 Training

Service representatives shall be trained in accordance to 7000003, Training Quality Procedure, and 7000045, Training Work Instruction prior to providing or performing service. Service provider training shall be managed by the respective organizations. Service providers shall assure personnel are qualified and trained prior to providing or performing service. Service providers shall maintain training records for service personnel for the terms outlined in 7000175, Maintenance, Control, and Retention Work Instruction.

10.2 Work Site

Service representatives and service providers shall establish a safe, adequately controlled work environment. The person performing service selects and establishes a controlled work site prior to starting any service activity. At a minimum, the work site:

Has adequate space to safely perform the required task(s)

Has adequate lighting to safely perform the required task (s)

Provides the ability to deploy ESD controls and after deployment, the work site passes resistance testing (Refer to requirements identified in the Electrostatic Discharge Work Instruction, 7000145)

Affords reasonable protection from interruption and extremes of temperature and weather

10.3 Measurement and Test Equipment

Service representatives calibrated field service tools shall comply to 7000018 Inspection, Measuring, Test and Process Equipment Quality Procedure (IMTPE) and 7000155 Calibration Program Work Instruction. Prior to performing service, the service representative shall:

Determine prior to use that Inspection, Measuring, Test and Process Equipment (IMTPE) has not exceeded the calibration due date, if applicable

Complete required verification at intervals prescribed on applicable tools

Maintain appropriate accessories in order to accomplish specified acceptance and test activities. In the event a piece of controlled or calibrated piece of equipment becomes inoperative, the service representative shall take the following steps:

Identify the item, listing its unique identifier and the observed malfunction

Segregate the item to prevent inadvertent use

Notify the designated maintenance entity to obtain replacement

Return the inoperative item to a designated maintenance entity Service providers shall have established inspection, measuring, test and process equipment procedures and maintain equipment and records.









10.4 Decontamination of devices (products)

Service representatives are responsible for knowledge and practice of decontamination techniques to reduce the potential for occupational exposure to blood-borne pathogens or Other Potential Infectious Materials (OPIM). Service representatives shall be trained to the Infection Control Procedure for Occupational Exposure to Blood Borne Pathogens defined in the 7000100, Contamination and Infection Control Work Instruction. Service providers shall have established processes for reducing the potential for occupational exposure to blood-borne pathogens and OPIMs. Service representatives and service providers shall use only approved cleaning solutions or processes to decontaminate devices (reference the device service manual or operating instructions). References:

Document ID Document Title

Chapter 296-823 Washington Industrial Safety and Health Administration (WISHA) Bloodborne Pathogens Standard Washington Administrative Code (WAC)

29 CFR 1910.1030 Occupational Safety and Health Administration (OSHA Bloodborne Pathogens Standard

Title 10, Section 10.08.051 King County Solid Waste Regulations

21 CFR 820 Food and Drug Administration (FDA) Department of Health and Human Services Subchapter H--Medical Devices part 820 Quality System Regulation

Directive 2000/54/EC Biological Agents at Work

Working Conditions Act Netherlands

CUSTOMER PROPERTY

Service representatives and service providers shall maintain control and safeguard customer’s property. If any customer property is lost, damaged, or otherwise found to be unsuitable for use, it must be reported to the customer and any discrepancies resolved. If a device given to a service representative or service provider is unsuitable for use, it may be returned to the customer along with a written communication indicating the device is unsuitable for service and should be removed from service. A copy of the communication should be attached to the service record.

11.1 Identification of device not matching as-built (manufactured) or upgraded configuration (Applies to service representatives only)

If a customer-owned device is suspected to not match its manufacturing configuration or upgraded configuration, discontinue servicing of the device immediately and contact your local leadership. The Service Representative and Leadership should work with the appropriate support members to resolve the issue. Examples of how device may not match its as-built or upgraded configuration:

Device configuration does not match Physio installed base record

Device labeling is inconsistent with configured device options

Installed configured options were not purchased through Physio

Installed parts were not sourced through Physio Examples of possible resolutions when a device doesn’t match as built or upgraded configuration:









Email device tracking to request an update to the installed base record. Reference 7000024 Device Tracking Work Instruction

Refuse to provide service and provide the customer with a written communication of the refusal rationale

Return the device to the as-built configuration

11.2 Patient Data Privacy

Service representatives and service providers shall take precautions to assure patient data privacy. Service personnel shall treat all patient data received as confidential, protected under the health the Health Insurance Portability and Accountability Act (HIPAA), or other related regulations. This information shall not be transmitted or disclosed except within the context and per requirements for product analysis and regulatory reporting.

SERVICE DOCUMENTATION AND PROCESSES

Service representatives and service providers shall only use released service processes or instructions when servicing, installing, deploying, or training on a device. Documentation is classified into several groups including but not limited to:

Service Manuals

Service Process Work Instructions

Technical Service Updates (TSU)

Technical Bulletins (TB)

Operating Instructions (OI) Service representatives:

Shall determine service documentation or procedures required to complete service on any devices to be serviced.

Shall use the latest revision of the service documentation or procedures to service devices.

Shall verify they have completed training on the use of any service documentation or procedures to be used to service devices before performing service.

SERVICE TOOLS

Physio provides software and hardware service tools. Service tools are documented within the service processes.

13.1 Software Tools

Physio provides software tools for use by service and customers. Distributed software or software tools shall be directly acquired from the business system and/or distribution shall be coordinated through Physio resources.

13.1.1 Customer Service Combined Loader (CSCL 3206213-XXX)

The customer service combined loader software shall only available to Physio service representatives and service providers and shall not to be shared with anyone else without the written approval from Leadership.

13.1.2 LIFENET

The LIFENET service tool is available to service and customers. Customers must have a LIFENET account to get access to the tools available within LIFENET.

13.2 Hardware Tools

Unless otherwise specified, tools used to perform service are commercial off the shelf tools. In the case where proprietary tools are required; Physio may provide service providers with the tools, or direction on how to source









the tools. Service to devices shall only be performed with appropriate tools, unless limited or specifically excluded by a procedure.

13.3 Device Software

The installation of system software is treated the same as an installation of a component. This activity is documented on a service record and the software part number or software upgrade kit number is shown as an installed component.

Older versions of software are not used to replace a newer version of software, such as downgrading a device to a previous software version, unless otherwise authorized in a Technical Services Update (TSU) (note: this refers to the overall system software and not the individual component software).

Service Representatives shall install the most current required software in a device after a repair or during contract maintenance. Required updates shall be identified by reviewing PC000226. The software should not add features or options to a device, except when a software update and software upgrade are in the same software package and cannot be separated. If damage to the device precludes determination of its original configuration, contact Physio Technical Support for assistance.

13.3.1 Update Operating System Software to Correct Performance Issues

Operating System Software is a traceable medical device component. Installation of Operating System Software is to be performed in accordance with Physio procedures that control product configuration management and device tracking. Software installed as part of a repair action is used to restore a device to its “original” configuration of features and options. System software that changes or adds features and options will constitute a software upgrade and must be documented as such.

13.3.2 Upgrading Operating System Software to Add Features

When installing a Printed Circuit Board (PCB) as part of a device feature upgrade, system software shall be installed at the most current required level. Required levels can be identified by reviewing PC000226. Software shall be installed after all hardware installation activities are complete. Device feature upgrades may be added to specific products via the upgrade process.

Device features shall not be removed from a product, unless directed by a TSU or an upgrade process.

CUSTOMER DEVICE CONFIGURATION ASSURANCE

Service representatives and service providers shall not make changes to a device’s manufacturing configuration unless purchased or requested by the customer. Service representatives and service providers should not make changes to setup options unless requested by the customer. Any changes or deviations to this should be noted in the service record along with the requestor of the changes.

14.1 Device Compliance Tool (DCT)

Where available, the Device Compliance Tool (DCT) can be used to perform several functions (Ref. PC000220) including:

Verification of the devices manufacturing configuration before and after service

Verification of the user setup options of the device before and after service

Launching the computer assisted performance inspection procedure (PIP)









Automatically generating and attaching the results of the above items in the ServiceMax work order. For configurable medical devices, in order to verify that devices are properly configured to specification, the Service Representative:

Shall perform a pre-work download of device data

Shall perform a post-work download of device data

Shall confirm after the completion of work that the device conforms to the specified configuration prior to release to the customer

If the pre-work download, or post-work download is unavailable, or the device does not conform to the specified configuration, the reason should be noted in the WO.

INVENTORY AND MATERIAL MANAGEMENT

Service representatives are responsible for maintaining material in their inventory per the requirements in 7000014, Handling, Storage, and Distribution Quality Procedure. Service providers shall have established processes for inventory and material management for:

Control of Conforming Material

Control of Nonconforming Material

Methods to collect and report nonconforming material

Requirements for returning material

Requirements for scrapping material

15.1 Control of Conforming Material (Applies to service representatives only)

Product received shall be inspected for damage, correct item, and quantity. If issues are detected, the material shall be returned or scrapped and new material re-ordered. Material shall be marked and segregated from other material until it is dispositioned. The service representative should, at a minimum, maintain inventory in its original shipping container or, if necessary, with its unique identifier attached. Items that are date sensitive or lot controlled should be consumed on a first-in-first-out basis. Product shall be stored in such a manner that provides segregation and prevents damage, deterioration contamination, or other adverse effects. Conforming and nonconforming material shall be segregated.

15.2 Control of Nonconforming Material identified during service (Applies to service representatives only)

When nonconforming material is detected, the material shall be identified with the item number and status, and segregated. If an item or device is covered by a New Product Evaluation Plan (NPE), follow the NPE plan for direction.









15.2.1 Collection and return of nonconforming material identified during service (Applies to service representatives only)

If an item or part contributed to the failure of a medical device and is replaced or repaired, the replaced item shall be collected and returned as required for possible further analysis. If it is material removed from a device or is associated with a customer call for service/repair, the item shall also be identified with the service record associated with the repair and collected as required. Exceptions to this are:

Failures that are due to abuse

Items that have expected wear and tear such as: o Device Cases o Bumpers o Guards o Lens protectors o Storage Bags o Handles o Covers

Parts that are in a working condition but being replaced as part of preventative maintenance and not a repair

Exceptions apply only if the part in question did not contribute to a device failure. If the part contributed to a device failure, it shall be collected and returned as required for possible further analysis. If an OEM accessory is replaced or repaired alongside a device failure, the replaced OEM accessory shall be collected and returned as required for possible further analysis along with the other items. If it is material removed from a device or is associated with a customer call for service/repair, the item shall also be identified with the service record associated with the repair. If an OEM accessory is replaced or repaired under warranty, the replaced item shall be collected and returned as required for possible further analysis. If it is material removed from a device or is associated with a customer call for service/repair, the item shall also be identified with the service record associated with the repair. Additional items or OEM accessories may be collected as required or directed. Items in the US shall be routed to the failure analysis center (FAC) in Redmond for disposition, while items outside the US shall be routed to the responsible non-Redmond partner warehouse for disposition.









15.3 Methods to Collect and Report Nonconforming Material (Applies to service representatives only)

Nonconforming material is collected and documented utilizing one or more of the following methods:

Return Material Authorization (RMA) – an identification number assigned to control the return of materials. The RMA also documents the return of customer-owned products

Service Record – a document used to record the action taken to return nonconforming product to a state of conformance with established requirements including, but not limited to, items below:

o Removal and installation of material o Accessory Replacement

Complete the service record using the device information the accessory was used with. If the device the accessory was used with cannot be determined, it is acceptable to document the accessory on the service record

o Nonconforming items replaced during a repair Documented as removed material on a service record

o Service kits Kits are not to be documented as removed material. Document the item number and

tracking information (serial number, lot or date code) of the assembly that was the cause for the reported issue.

15.4 Requirements for Returning Nonconforming Material (Applies to service representatives only)

Nonconforming material, unless specifically exempt as outlined below, is returned as follows:

Returned material is shipped to Physio Redmond or the local Non Redmond Partner Warehouse (NRPW) within 14 days of removal of the material, unless otherwise specified in a TSU, Technical Bulletin, or work instruction. It is permissible to consolidate material for return, provided the requirements to prevent damage, deterioration or misidentification during handling and shipment are met.

Returned material should reference the RMA number, applicable case, work order or service record number, item number and status. This information may be put into the shipping return label.

If the Service Representative uses the original shipping container, the service representative should line out the original part number/serial or lot number label on the box.

Returned Electrostatic Discharge (ESD) sensitive material MUST be packed and shipped in ESD safe packaging. The ESD packaging that the replacement part was contained in can be reused as packaging to ship returned material.

o ESD packaging shall NOT be sealed with any type of metallic fastener (for example metal staples). To prevent component damage, printed circuit boards MUST not use rubber bands.

In the US, it is required that all nonconforming parts (including accessories) removed during servicing be returned to Physio Redmond on an RMA for further analysis.

OUS Service Representatives shall follow local processes for return of nonconforming items replaced during a repair.

Return of material due to a Product Hold Order (PHO) shall be shipped separate from repair material. PHO material is new material only. If the Service Representative has opened the material box or bag, the RMA MUST indicate that the material is “NEW” and indicate the PHO number.

15.5 Exemptions from Returning Nonconforming Material (Applies to service representatives only)

Certain items of nonconforming material are exempt from return for analysis as follows:

Items replaced as part of a Technical Service Update (TSU), or other service process, unless the TSU instructions specify the return of removed material.

Exceptions documented within released service processes.









15.6 Requirements for Returning Conforming Material (Applies to service representatives only)

Excess inventory should be returned in its own packaging and separate from any other types of returns. Excess inventory is new material only. If the Service Representative has opened the material box or bag, the RMA MUST indicate that the material is “new”.

Returned material must have a reference on the outside of each shipping box. This information may be documented on the shipping return label.

o RMA - an open RMA number is written on the outside of the box o Refused Shipment - the Sales or T order number written on the outside of the box

15.7 Exemptions from Returning Conforming Material (Applies to service representatives only)

Certain items of conforming material are exempt from return as follows:

Conforming items replaced as part of the repair that had to be removed to facilitate the repair of the unit. Examples are: using new case screws after opening the unit, removing tie- wraps to repair a harness, and replacing labels while replacing the case.

Conforming items replaced as part of an upgrade to add a new feature unless the upgrade instructions specify the return of removed material.

Conforming items replaced as part of regularly scheduled maintenance. This conforming material once removed shall not be reused; it is to be scrapped locally.

15.8 Scrapping New Material in Inventory in the Field (Applies to service representatives only)

Items can be scrapped in the field if directed by the factory or if the item is being rejected, is un-usable, expired, or obsolete. Field service representatives shall follow the requirements in 7000360, Scrap Control Work Instruction, when items are to be scrapped in the field.

LOANER INVENTORY CONTROL (APPLIES TO SERVICE REPRESENTATIVES ONLY)

The Service Representative shall:

Track loaner devices assigned to them

Complete a service record showing the device is on loan

Clear the device of any patient-related data

Assure a PIP is performed on a device before it’s sent to a customer and the results are included in a service record

If a loaner device or serialized device needs to be scrapped, the service representative shall follow the Scrap Control Work Instruction 7000360.

CUSTOMER FEEDBACK (APPLIES TO SERVICE REPRESENTATIVES ONLY)

Information and data within a customer complaint or service record is considered customer feedback. Feedback not already captured within a customer complaint or service record, may be submitted to the internal designee for submission per 7000821 Product Issue Tracking Work Instruction.

MAINTENANCE, CONTROL, AND RETENTION OF RECORDS

Service records shall be maintained, controlled, and retained as required per 7000175 Maintenance, Control, and Retention of Records Work Instruction.









Indirect resource providers shall keep and maintain records for the lengths required per 7000175 Maintenance, Control, and Retention of Records Work Instruction unless otherwise stated in an agreement or contract with Physio or Stryker. Indirect service providers shall be able to produce or present requested records within 36 business hours of a request being made.

APPENDICES

N/A

Documents

Document Detail - Stryker Corporation · Product Lifecycle Management (PLM) system. A device software set contains one version of the Operating System Software for a specific Physio