Document Detail - Stryker Corporation · actions. They provide specific, detailed instructions to...

PHYSIO-CONTROL

11811 WILLOWS ROAD NE - POST OFFICE BOX 97006

REDMOND

WASHINGTON

9/25/2018

1

Document Detail

Type: QUALITY SYSTEM DOCS

7000022[K]Document No.:

SERVICING QUALITY PROCEDURETitle:

SALAZJ1 Juan SalazarOwner/Modifier:

CURRENTStatus:

Effective Date: 25-Sep-2020View Expiration Date:25-Sep-2018

Document Build

No.

Access Activity Accessed By Accessed Date

Revision Notes

1 Check In 28-Aug-2018SALAZJ1

Note: 7000022 J to K redlines

2 Check In 28-Aug-2018SALAZJ1

Note:

3 Check In 28-Aug-2018HOWEA1

Note: fix formatting

4 Check In 30-Aug-2018HOWEA1

Note: fix doc structure, remove Stryker glossary ref

9/25/2018

2

Document Detail

Review

APPROVAL

Review Purpose: Initial document review and approval.

Review:

Build No.: 4 Closed Date: 8/31/2018 6:10:42PM

Review Note: SYSTEM AUTO CLOSE REVIEW

Sign-off ByActorOwner RoleLevel Sign-off Date

HOWEA1HOWEA1 Andrea HoweDOCUMENT CONTROL

DOCUMENT CONTROL

0 30-Aug-2018 8:53 pm

Note To Approver:

Note From Approver:Quality check complete

ERICKS2ERICKS2 SCOTT ERICKSONQUALITY SYSTEM MANAGER

QUALITY SYSTEM MANAGER

1 30-Aug-2018 9:43 pm

Note To Approver: Signing in place of Kim Dashen, Quality System Manager (see attached delegation email)

Note From Approver:I approve this quality procedure revision.

SALAZJ1SALAZJ1 Juan SalazarQS PROCESS OWNER QS

PROCESS OWNER

1 30-Aug-2018 9:30 pm

Note To Approver:

Note From Approver:Approved

SALAZJ1SALAZJ1 Juan SalazarQS SYSTEM OWNER QS SYSTEM

OWNER

1 30-Aug-2018 9:30 pm

Note To Approver:


BELLC1BELLC1 Casey BellTRAINING PROCESS OWNER

TRAINING PROCESS OWNER

1 31-Aug-2018 2:00 pm

Note To Approver:

Note From Approver:Approved.

HUBERD2HUBERD2 DAVID HUBERDOCUMENT APPROVER

DOCUMENT APPROVER

1 31-Aug-2018 6:10 pm

Note To Approver:


Title SERVICING QUALITY PROCEDURE Page Page 1 of 11

Doc Type QUALITY SYSTEM DOCS

Process Owner SALAZJ1 Doc # 7000022

Doc State CURRENT Effective Date 9/25/2018 Doc Rev K

QS System Service Provision QS Process Field Service Depot Aftermarket

QS Parent 8000000, Physio-Control Quality Manual

Confidential – Stryker Proprietary Information – Do Not Duplicate

Quality Work Instruction Template: 8000861_D 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

Updated to new template.

Update to add the Technical Support Service Work Instruction. Added to document tree structure, references, and section 7.1.

Updated section 8 to align with Stryker verbiage.

Effective upon release.

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

CH000821 J Updates for ISO 13485:2016 and MDSAP

CH000891 K Update to add 7000891 Technical Support Service Work Instruction









PURPOSE

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

SCOPE

This procedure covers service performed by Physio service representatives and service providers. The requirements within this document apply to both Physio service representatives and service providers unless specifically excluded.

REFERENCES

3.1 Document Structure Diagram

Quality Manual

8000000

Physio-Control Quality Manual

Work Instruction

7000742

Service Support

Document

Development

Work Instruction

7000764

Refurbished (RELI),

ACLS (trainer), and

Parts Salvage

Work Instruction

7000855

EMEA RELI

Work Instruction

7000717

Evaluation, Loaner,

and Demonstration

Quality Procedure

7000763

Refurbished (RELI), ACLS

(trainer), and Parts Salvage

Work Instruction

7000891

Technical Support

Service

Quality Procedure

7000022

Servicing

Work Instruction

7000101

Returned Product

Classification and

Disposition

Work Instruction

7000180

Servicing Process

Work Instruction

7000679

Europe Returned

Material Routing

Work Instruction

7000181

Service

Communications









3.2 Internal References

Document Number Title

7000018 Inspection, Measuring, Test and Process Equipment Quality Procedure

7000101 Returned Product Classification and Disposition

7000131 Supplier Selection Work Instruction

7000145 Electrostatic Discharge Work Instruction

7000180 Servicing Process Work Instruction

7000181 Service Communications Work Instruction

7000666 Quality Management System Requirements Traceability Matrix

7000679 Europe Returned Material Routing

7000717 Evaluation, Loaner, and Demonstration

7000742 Service Support Document Development Work Instruction

7000763 Refurbished (RELI), ACLS (Trainer), and Parts Salvage

7000764 Refurbished (RELI), ACLS (Trainer), and Parts Salvage

7000855 EMEA RELI

7000866 Failure Analysis Center Work Instruction

7000891 Technical Support Service Work Instruction

8000000 Physio-Control Quality Manual

8000006 Corrective and Preventive Action Quality Procedure

8000007 Complaints Quality Procedure

DEFINITIONS, TERMS, AND ACRONYMS

4.1 Locally Defined Terms

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

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

Contractor N/A

An individual, partnership, company, corporation, association, or other organization, that provides miscellaneous goods and/or services based on either a specific need or a contractual agreement. Reference CQM-02

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

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.

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. RELI 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.

Third-Party Service Providers

N/A Third-party organizations contracted by Physio to perform service on behalf of Physio.

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.









ROLES AND RESPONSIBILITIES

Roles Responsibilities

Physio Service Operations

Provides technical training, creates Service Manuals, Technical Bulletins, and Technical Service Update documentation and distributes these Documents to Physio Service representatives

Physio Service Representatives

Ensure compliance to this procedure.

Service Providers Ensure compliance to this procedure.









PROCESS FLOW

SIPOC DIAGRAM – Servicing Quality Procedure

CUSTOMEROUTPUTPROCESSSUPPLIER INPUT

START

Request for Service or Field Action

Service Device- In the field- In a depot

Update Device Location if required

(section 10)

END

Servicing of Medical Devices

Team Members

Customers

Field Service Representatives

Service Depot Technicians

Technical Support

Customer Support

Sales

Marketing

Service Providers

Request for Service

Customer Contact

Field Action

Service Report

Complaint

Device Tracking Update

Parts/Device Return

Team Members

Complaint Team

Design Quality

CAPA

Field Action

Document Completion of work in a Service Record

(section 8)

Return parts as required

(section 19)









SIPOC DIAGRAM – Servicing Quality Procedure

CUSTOMEROUTPUTPROCESSSUPPLIER INPUT

Service Support Document Development

Field Service Representatives


Customer Support

New Product Development

Field Actions Team

Complaint Handling

Service Providers

Escalations

Documentation redlines

Change in parts or process

Need for a TSU

New business need

Collecting of additional information from the field

Service Manuals

Service Process Work Instructions

Technical Service Updates (TSU)

Technical Bulletins (TB)

Operating Instructions (OI)

Service Representatives

Service Partners


Complaints Handling

Customers/Biomeds

Technical Support

Customer Support

Field Actions Team

START

Request or Need for Service Process

Develop Service Process per 7000742

Service Support Document

Development Work Instruction

(Sec 15)

END

Deploy training to personnel(Sec 11)

SERVICES

Physio shall provide service to its customers in the form of support, repairs, upgrades, testing, and technical training.

7.1 General Support

Physio provides general support to its customers and partners in the form of phone support or in-person support. Technical support or product support shall be provided in accordance to the respective instructions for use, operating instructions, or service documentation. Reference 7000891 Technical Support Service Work Instruction for additional information.









7.2 Repair, Upgrade, and Testing

Physio provides repair, upgrade, and testing services to its customers and partners. Repair, upgrade, and testing shall be performed in accordance to the respective instructions for use, operating instructions, or service documentation.

7.3 Refurbishment and Repurposing of Product

Physio takes previously distributed product and repurposes them as a RELI device or accessory, ACLS device or accessory, or uses them for salvage of components or subassemblies.

7.4 Technical Training

Physio may provide technical training to its customers and partners on how to perform general maintenance, preventative maintenance, and repair of devices. Technical training shall be based on released processes and work instructions but can be customized to the customers’ needs if the information trained to does not conflict.

7.5 Service Resources

Service shall be provided by qualified and trained service personnel. Physio uses service representatives and service providers:

Service Representatives:

o Physio Team Members- The use of direct Physio Team Members for providing service in the field, depot, or over the phone (or other medium).

o Contracted Resources- The use of contracted resources for providing service in the field, depot, or over the phone (or other medium). Contracted resources report to and work for Physio. Contracted resources may be directly contracted, or contracted through a staffing company.

Service Providers:

o Third-party- The use of third-party organizations for providing service in the field, in a depot, or over the phone (or other medium). Third-party service providers work independent of Physio. Third-Party service providers shall be on the approved vendors list as required per 7000131 Supplier Selection Work Instruction.

o Distributors- The use of distributors for providing service in the field, in a depot, or over the phone (or other medium). Distributors work independent of Physio. A distributor agreement must be in place as required per the company policy, Distributor and Sales Agent Appointment, Contracting and Management Policy.

SERVICE RECORDS

Service representatives and service providers shall document all service performed on medical device in a service record.

Service records shall contain or have access to the following when available:

The name of the device serviced

Device identification(s) and control number(s)

The individual servicing the device

The service performed

The test and inspection data









COMPLAINTS

Service representatives and service providers shall adhere to the general requirements outlined for complaint handling per 8000007 Complaints Quality Procedure.

DEVICE TRACKING UPDATES

Service representatives and service providers shall update customer device location when made aware of a change.

Excludes devices in transit, or devices sent into a depot for repair.

TRAINING

Service representatives and service providers shall be trained prior to, repairing, upgrading, testing, or performing routine maintenance on products.

Service representatives and service providers shall be trained on Physio quality process requirements prior to repairing, upgrading, testing, or performing maintenance on products.

WORK ENVIRONMENT

12.1 Measuring Equipment

Service representatives and service providers shall use calibrated equipment as required. Reference 7000180 Servicing Process Work Instruction for additional information.

12.2 Electrostatic Discharge (ESD) Protections

Service representatives and service providers shall take precautions and establish an electrostatic discharge (ESD) safe work area.

12.3 Contamination Control

Service representatives and service providers shall take precautions to minimize the risk of exposure to infectious agents when receiving or handling product.

CUSTOMER PROPERTY

Service representatives and service providers shall maintain control of 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. They shall assure that any device received that is in a failed state, or that does not conform to product requirements is identified and segregated from conforming product.

PATIENT DATA PRIVACY

Service representatives and service providers shall take precautions to assure patient data privacy.

SERVICE PROCESSES

The servicing of a device shall only be performed according to approved and released processes. Service processes shall be created and validated per 7000742 Service Support Document Development Work Instruction.









SERVICE TOOLS

Service representatives and service providers shall use tools as required and documented within service processes.

CUSTOMER DEVICE CONFIGURATION

Service representatives and service providers shall not make changes to a devices’ manufacturing configuration unless purchased or requested by the customer. Service representatives and service providers shall not make changes to setup options unless requested by the customer.

SERVICE INVENTORY

Service representatives and service providers are responsible for inventory management of their service parts and to assure prompt return or disposal of any material removed from a repaired device.

Non-conforming parts or inventory shall be controlled.

FAILURE ANALYSIS CENTER RETURNS (APPLIES TO SERVICE REPRESENTATIVES ONLY)

Service representatives shall return non-conforming parts or devices to the Failure Analysis Center (FAC) for analysis as required in 7000180 Servicing Process Work Instruction.

REFURBISHING OR REPURPOSING OF PRODUCT (APPLIES TO SERVICE REPRESENTATIVES ONLY)

Product to be refurbished or repurposed shall meet all requirements for eligibility, regulatory, drawing, configuration, age, condition, testing, and relabeling as outlined within 7000763 Refurbished (RELI), ACLS (trainer), and Parts Salvage Quality Procedure. Refurbishment or repurposing shall follow the processes outlined within 7000764 Refurbished (RELI), ACLS (trainer), and Parts Salvage Work Instruction for the US, and 7000855 EMEA RELI Work Instruction for Europe, Middle East, and Africa region.

CUSTOMER FEEDBACK

Service representatives and service providers shall submit customer feedback as required and if not already captured in a complaint or service record.

CONTROL OF RECORDS

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

Document Detail - Stryker Corporation · actions. They provide specific, detailed instructions to...

Documents

Transcript of Document Detail - Stryker Corporation · actions. They provide specific, detailed instructions to...