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 PROCEDURE Title: SALAZJ1 Juan Salazar Owner/Modifier: CURRENT Status: Effective Date: 25-Sep-2020 View Expiration Date: 25-Sep-2018 Document Build No. Access Activity Accessed By Accessed Date Revision Notes 1 Check In 28-Aug-2018 SALAZJ1 Note: 7000022 J to K redlines 2 Check In 28-Aug-2018 SALAZJ1 Note: 3 Check In 28-Aug-2018 HOWEA1 Note: fix formatting 4 Check In 30-Aug-2018 HOWEA1 Note: fix doc structure, remove Stryker glossary ref
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Document Detail - Stryker Corporation · actions. They provide specific, detailed instructions to Physio Service Teams to conduct field repairs, product updates, product inspections,
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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:
Note From Approver:Approved
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:
Note From Approver:Approved
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
Title SERVICING QUALITY PROCEDURE Page Page 2 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
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
Title SERVICING QUALITY PROCEDURE Page Page 3 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
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
Title SERVICING QUALITY PROCEDURE Page Page 4 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
Term Acronym Definition
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
Title SERVICING QUALITY PROCEDURE Page Page 5 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
Term Acronym Definition
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.
Title SERVICING QUALITY PROCEDURE Page Page 6 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
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.
Title SERVICING QUALITY PROCEDURE Page Page 7 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
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)
Title SERVICING QUALITY PROCEDURE Page Page 8 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
SIPOC DIAGRAM – Servicing Quality Procedure
CUSTOMEROUTPUTPROCESSSUPPLIER INPUT
Service Support Document Development
Field Service Representatives
Service Depot Technicians
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
Service Depot Technicians
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.
Title SERVICING QUALITY PROCEDURE Page Page 9 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
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
Title SERVICING QUALITY PROCEDURE Page Page 10 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
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.
Title SERVICING QUALITY PROCEDURE Page Page 11 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
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