document detail - stryker corporation · gmp requirements for medical devices and ivds (rdc 16,...

PHYSIO-CONTROL

11811 WILLOWS ROAD NE - POST OFFICE BOX 97006

REDMOND

WASHINGTON

8/31/2018

1

Document Detail

Type: QUALITY SYSTEM DOCS

8000007[B]Document No.:

Complaints Quality ProcedureTitle:

MARSEM1 Megan MarsegliaOwner/Modifier:

CURRENTStatus:

Effective Date: 31-Aug-2020View Expiration Date:31-Aug-2018

Document Build

No.

Access Activity Accessed By Accessed Date

Revision Notes

1 Check In 03-Aug-2018MARSEM1

Note:

2 Check In 03-Aug-2018HOWEA1

Note:

Review

APPROVAL

Review Purpose: Initial document review and approval.

Review:

Build No.: 1 Closed Date: 8/6/2018 4:07:39AM

Review Note: SYSTEM AUTO CLOSE REVIEW

Sign-off ByActorOwner RoleLevel Sign-off Date

HOWEA1HOWEA1 Andrea HoweDOCUMENT CONTROL

DOCUMENT CONTROL

0 03-Aug-2018 5:55 pm

Note To Approver:

Note From Approver:Quality check complete

ERICKS2ERICKS2 SCOTT ERICKSONQS SYSTEM OWNER QS SYSTEM

OWNER

1 03-Aug-2018 7:55 pm

Note To Approver:

Note From Approver:I approve this revised Quality Procedure.

BANDYT1BANDYT1 TODD BANDYQS PROCESS OWNER QS

PROCESS OWNER

1 03-Aug-2018 7:03 pm

Note To Approver:

Note From Approver:Approved

KDASHENKDASHEN Kim DashenQUALITY SYSTEM MANAGER

QUALITY SYSTEM MANAGER

1 06-Aug-2018 4:07 am

Note To Approver:

Note From Approver:This is approved.

BELLC1BELLC1 Casey BellTRAINING PROCESS OWNER

TRAINING PROCESS OWNER

1 03-Aug-2018 6:49 pm

Note To Approver:

Note From Approver:Approved.

Title Complaints Quality Procedure Page Page 1 of 13

Doc Type QUALITY SYSTEM DOCS

Process Owner BANDYT1 Doc # 8000007

Doc State CURRENT Effective Date 8/31/2018 Doc Rev B

QS System Measurement, Analysis, & Improvement

QS Process Complaints

QS Parent 8000000, Physio-Control Quality Manual

Confidential – Stryker Proprietary Information – Do Not Duplicate

Quality Procedure 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 section 7.3 to include latest UDI requirements.

Updated references to include latest document numbering changes and added Corporate Quality Procedure, CQD-REG-006, Unique Device Identifier.

Removed references to RRFs as this is no longer a part of the CAPA process.

Updated section 7.7 to reference the updated procedure and work instructions.

No retrospective application of this Work Instruction as the additions identify information already required by the FDA and the complaint handling software already requires these items in its input fields.

Read and understand training of the Stryker Corporate Quality Procedures and Work Instructions listed in section 3.2, external references, is required for all roles assigned to this document.

Read and understand training is required for all roles assigned to this document.

Revision History

CO Revision Reason for Change

CH000771 A Complete rewrite to align with Stryker’s Complaint Handling Process; as well as for clarity and to meet MDSAP and ISO13485:2016 standards.

CH000879 B Added UDI reference and removed references to RRFs. Removed use error section. Updated procedure for tracking and trending.










PURPOSE

The purpose of this quality procedure is to define the requirements for ensuring that Complaints are received, documented, reviewed, evaluated and investigated in a consistent and timely manner by a formally designated unit.

This procedure defines the requirements for reporting to regulatory authorities.

SCOPE

2.1 This procedure applies to: All Physio-Control, now a part of Stryker (Physio) direct team members, consultants, contractors and Stryker sites acting on behalf of Physio who receive a complaint for Physio products and services.

2.2 Applicable to all products distributed by Physio.

2.3 Reporting to regulatory authorities in accordance with:

FDA 21 CFR Part 803

Canadian Medical Device Regulations (SOR/98-282)

GMP Requirements for Medical Devices and IVDs (RDC 16, 2013)

Technovigilance Requirements for Registration Holders (RDC No. 67, 2009)

Australian Therapeutic Goods Act 1989

Taiwan Food and Drug Administration (TFDA)

MEDDEV 2.12-1 Rev 8, Guidelines on a Medical Devices Vigilance System, July 2013

MEDDEV vigilance reports to the EU Competent Authorities on behalf of Jolife AB (a wholly owned subsidiary of Physio)

Federal Aviation Administration (FAA)










REFERENCES

3.1 Document Structure Diagram

Quality Procedure

8000007

Complaints

Quality Manual

8000000

Physio-Control Quality Manual

Work Instruction

8000087

Product Complaints

Work Instruction

7000340

Technical Support

Contact Tracking

Work Instruction

7000362

Medical Device Reporting

Work Instruction

7000866

Failure Analysis Center

3.2 External References

3.3 Internal References

*Indicates reference to Stryker Corporate Procedures, which although not released on the Physio Quality System, Physio team members have access to via Stryker credentials: http://cdserver.strykercorp.com/corpDocs/.

Document Number Title

7000196 Device Tracking Work Instruction

7000340 Technical Support Contact Tracking Work Instruction

7000362 Medical Device Reporting Work Instruction

7000378 Federal Aviation Administration Requirements Work Instruction

7000508 24 Hour FAA Report Form

7000509 Clinical Review for Potential Adverse Event Report Form

7000510 Clinical Review of Verified Malfunction Form


21 CFR Part 820.198 Complaint Files

Form 3500A MedWatch Form

ISO 13485 Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes

MEDDEV 2.12-1 Guidance on Medical Device Vigilance System

http://cdserver.strykercorp.com/corpDocs/











7000648 Complaint Intake Form

7000866 Failure Analysis Center Work Instruction

8000006 Corrective and Preventive Action Quality Procedure

8000035 Management Review Work Instruction

8000036 Product Review Board Work Instruction

8000084 Nonconformance Work Instruction

8000087 Product Complaints Work Instructions

8000090 Field Action Work Instruction

*CQM-02 Stryker Corporate Glossary

*CQD-REG-006 Stryker Corporate Quality Procedure-Unique Device Identifier

*CQP-PMS-001 Stryker Corporate Quality Procedure-Complaint Handling Process

*CQP-PMS-005 Stryker Corporate Quality Procedure-Service Report Handling

*CQI-PMS-001-03 Stryker Corporate Quality Work Instruction-Complaint Intake Center (CIC)

*CQI-PMS-001-04 Stryker Corporate Quality Work Instruction-Complaint Management Center (CMC)

*CQI-PMS-001-07 Stryker Corporate Quality Work Instruction-Product Assessment Center (PAC)

PC000550 Complaint Owner-Complaint Record Task, SmartSolve Complaint Training Materials

DEFINITIONS, TERMS, AND ACRONYMS

4.1 Terminology

Refer to CQM-02, Stryker Corporation Quality and Regulatory Master Glossary, for definitions of the following key terms used within this document (http://oneplm.strykercorp.com/corpDocs/).

Adverse Event

Awareness Date

Become Aware

Business Day

Cause

Caused or Contributed

Complaint

Contractors/Consultants

Calendar Days

Corrective Action

Corrective and Preventative Action

Distribution OEM Owners

Electronic Record

Electronic Signature

Failure

Failure Mode

Harm

Hazard

Hazardous Situation

Health Care Practitioner

Health Care Professional

Health Hazard Evaluation

Immediately

Incident

Information Reasonably Known

Initial Reporter

Investigator

Malfunction

Manufacturer

Medical Device

Medical Device Reporting Reportable Event

Medical Device Vigilance Report

Nonconformance

OEM Product

Originator

Product(s)

Product Inquiry

Publication

Reasonably Suggests

Record

Regulatory Agency

http://oneplm.strykercorp.com/corpDocs/










Reporter

Risk

Risk Analysis

Root Cause

Serious Injury

Service Report

Service Request

Social Media

Unique Device Identifier

User Error

Working Days

4.2 Locally Defined Terms

Term Acronym Definition

Adverse Event per ANVISA

N/A Any undesired effect in humans coming from the use of products under sanitary surveillance.

Adverse Event Report

AER N/A

ANVISA N/A Brazilian Regulatory Agency

NA APAC Asia-Pacific region, including but not limited to Japan, China, Hong Kong, Australia and New Zealand.

Case N/A The CHS record that contains the initial event information in SFDC.

Complaint Handling System

CHS Complaint management system that is used to document and manage product complaints.

Customer Quality Assurance Engineer

CQA Engineer

A member of the Product Analysis Center who is assigned the following roles:

Investigator

Approver

NA EMEA Europe, Middle East and Africa region.

Failure Analysis Technician

FAC Technician

A member of the Failure Analysis Center who is responsible for the following:

Analyze/test devices, subassemblies, and components to identify the failed component or area of reported and observed failures.

Document findings in the service application.

Formally Designated Unit

N/A Individual or team that establishes and maintains procedures for receiving, reviewing, and evaluating complaints to ensure:

Processing in uniform and timely manner

Documentation of oral complaints upon receipt

Evaluation to determine if failure investigation and/or a medical device report (MDR) is required

Health Canada N/A The medical device regulatory body in Canada

Medsafe N/A Medical device regulatory body in New Zealand

Ministry of Health Labor and Welfare

MHLW Ministry of Health Labor and Welfare – Japan

Non-Severe Adverse Event per ANVISA

N/A Any other adverse event that is not included in the severe adverse event criteria.

Pharmaceuticals and Medical Devices Association

PMDA Pharmaceuticals and Medical Devices Association – Japan










Term Acronym Definition

Quality Regulatory Affairs Coordinator

QRA Coordinator

A member of the Complaint Management Center who is assigned one or more of the following roles:

Reviewer

Coordinator

Originator

Quality Regulatory Affairs Specialist

QRA Specialist

A member of the Complaint Management Center who is assigned one or more of the following roles:

Reviewer

Coordinator

Regulatory Representative

Approver

Remedial Action Exemption

RAE An exemption that is granted in the event of a field corrective action by a governing regulatory body which allows for specific product events to no longer require reporting as a reportable complaint.

Review Request Form

RRF Review Request Form, which is used to document preliminary investigations in order to facilitate a decision as to whether further investigation under a CAPA is required for an observed event.

SalesForce.com SFDC Web-based Service Management system used to document product issues and complaints

Severe Adverse Event per ANVISA

N/A Adverse event that is fitted in at least one of the following situations: (a) causes death; (b) causes permanent disability or harm to a body structure; (c) requires medical or surgical intervention in order to prevent a permanent compromise of a body function or structure; (d) requires hospitalization or prolongation of hospitalization for a patient; and (e) causes fetal disturbance or risk, fetal death, or congenital anomaly.

SmartSolve System

N/A One of the complaint management systems that is used to document and manage product complaints. This system is used to facilitate the Medical Device Reporting (MDR) for events that meet the regulatory requirements.

Technical Support Specialist

N/A A member of the Complaint Intake Center who is responsible for the following: Receives information, enters data into SalesForce.com, asks quality screening questions, and obtains as much information as possible on first contact. Supports CMC and PAC to gather additional complaint information.

Therapeutic Goods Administration

TGA Therapeutic Goods Administration, medical device regulatory body in Australia

TrackWise N/A One of the complaint management systems that is used to document and manage product complaints. This system is used to facilitate the Medical Device Reporting (MDR) for events that meet the regulatory requirements.










ROLES AND RESPONSIBILITIES

5.1 CHS uses several user roles to complete the complaint handling process. Stryker entities shall identify staff to fulfill roles and responsibilities listed below:

5.1.1 A user may fulfill multiple responsibilities within CHS. Roles and responsibilities listed below are an overview of major roles and responsibilities and may be fulfilled by multiple Centers.

Center Roles Responsibilities

N/A Physio team members and contract employees

Any Physio team member or person acting on behalf of Stryker who becomes aware by email, phone, fax, mail, verbally, or other means of a possible complaint shall submit/forward complaint information to a CIC immediately. The targeted timeframe is one (1) business day.

Consultants and contractors are considered to be Stryker employees or employees acting on behalf of Stryker.

N/A Physio Clinical Representative/Clinical Affairs Specialist

A representative from Clinical Affairs who reviews certain events to determine if the patient outcome of the event was the result of a Physio product.

Complaint Intake Center (CIC)

Originator Reviewer Regulatory Representative Approver

The Stryker entity or location that enters event information into CHS. Receives information, enters data into CHS, asks quality screening questions, and obtains as much information as possible on first contact. Supports CMC and PAC to gather additional complaint information. Reviews newly released Product Inquiries (PIs) generated from web/mobile applications for completeness. Coordinates and escalates requests for additional information. Reviews and submits the PI for final closure. Coordinates customer feedback.










Complaint Management Center (CMC)

Reviewer Coordinator Regulatory Representative Approver

Manages the complaint handling process from complaint receipt to closure, maintains complaint related files, evaluates complaints, ensures appropriate action is taken for designated products/product families, and reviews issues for adverse event reporting. Coordinates initial activities necessary for the investigation of a complaint and escalates requests for information and ensures request acknowledged by the originator. Evaluates the complaint for reportability and/or generates the required regulatory submission forms. Evaluates investigations and entire complaint records for completeness, consistency, and compliance. Coordinates closure of the record family to ensure PI is ready for final approval by the CIC. Approves or rejects investigations and may re-open complaint records. Approves reportability decision, content of completed regulatory forms and submission. Flags complaint records with investigation results requiring re-evaluation of regulatory reporting decision. CMC is the division or business unit associated with the product reported in the event. The international distribution division may be considered the CMC when it is identified as the legal manufacturer of an OEM product.

Product Assessment Center (PAC)/Failure Analysis Center (FAC)

Investigator Approver

Conducts and documents complaint investigations. Evaluates investigations requiring additional technical approval for completeness, consistency, and compliance. Approves or rejects these investigations and may reopen complaint records. PAC is the site that performs the investigation regardless of the Stryker entity type.










SUPPLIERS-INPUTS-PROCESS-OUTPUTS-CUSTOMERS

SIPOC DIAGRAMComplaint Handling

CUSTOMEROUTPUTPROCESSSUPPLIER INPUT

START

Receive Information that possibly meets

criteria for a complaint

Complaint Intake (Section 7.2)

Complaint Management (Section 7.3)

Product Analysis (Section 7.4)

Close Complaint (Section 7.6)

END

Regulators Team Members Complaint

Team Tech Support Field Service

Reps Customers Service Depot Marketing Clinical FAC

Service data Complaint data Literature

Reviews; Published (scientific, medical, social media or other)

Clinical Review data

Regulators Team Members Complaint

Team Clinical Regulatory Design Quality CAPA Field Action

Complaint Record

Regulatory Reports

Complete regulatory reporting as

required (Section 7.5)










REQUIREMENTS

7.1 General Requirements

7.1.1 All Physio team members shall adhere to the general requirements outlined for complaint handling per Stryker Corporate Procedure, CQP-PMS-001.

7.1.2 All Physio team members may submit possible Complaint information by calling the CIC for direct entry; by submitting a paper based Complaint Intake form to the local CIC, 7000648; or by completing the required information in the web form or mobile application form at: www.stryker.com/productexperience

7.2 Complaint Intake

7.2.1 Once a Reporter/Complainant has contacted the CIC, the Originator shall enter the information to complete the required fields initiating a PI in accordance with Stryker Corporate Quality Work Instruction CQI-PMS-001-03, Complaint Intake Center (CIC).

7.2.2 Once a Reporter/Complainant has contacted Physio Technical Support department, a Technical Support Specialist or designee shall enter the information to complete the required fields initiating a Case in accordance with Physio Quality Work Instruction 7000340, Technical Support Contact Tracking.

7.2.3 Once a Reporter/Complainant has contacted a Physio Field Service Representative or designee, that representative shall enter the information to complete the required fields initiating a Case.

7.2.4 Other potential sources of complaints, such as published literature, shall be monitored by Physio marketing department. Records identified as complaints and not previously reported shall be processed in accordance with the complaint handling process.

7.2.5 Physio QRA Coordinator or designee shall review Service Reports for accuracy in accordance with Stryker Corporate Quality Procedure CQP-PMS-005, Service Report Handling. Physio QRA Coordinator or designee shall initiate a PI in accordance with Stryker Corporate Quality Work Instruction CQI-PMS-001-03, Complaint Intake Center (CIC) when a service report requires further investigation.

7.2.6 CMC shall review and submit the Complaint Record in accordance with Stryker Corporate Quality Work Instruction CQI-PMS-001-04, Complaint Management Center (CMC).

7.3 Complaint Management

7.3.1 Physio-designated CMCs shall manage complaints in accordance to Physio Quality Work Instruction 8000087, Complaint Handling, in conjunction with Stryker Corporate Quality Work Instruction, CQI-PMS-001-04, Complaint Management Center (CMC), and Stryker Corporate Quality Procedure, CQD-REG-006, Unique Device Identifier.

7.3.1.1 Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

7.3.2 Product Returns

7.3.2.1 Product return requirements are defined in CQP-PMS-001.

7.3.2.2 Where applicable, the complaint investigation includes a product analysis by FAC, if and when the product is made available by the customer. For products returned to Physio Failure Analysis Center (FAC): FAC shall maintain control, identification and proper disposition including investigation reporting of Material (Product, Assemblies and/or components) returned from the field to FAC in support of

http://www.stryker.com/productexperience










complaint investigations, field action, retention, and evaluation of potential emerging quality issues to determine if further action is required in accordance with Failure Analysis Center Work Instruction, 7000866.

7.3.2.3 For any other changes to the status or location of a device, reference Device Tracking Work Instruction 7000196. Examples include, but are not limited to, devices which are identified as, lost, stolen, permanently disposed of, traded in or permanently removed from service. Notification to Device Tracking shall be documented in the complaint record.

7.3.3 Clinical Reviews

7.3.3.1 The QRA Specialist or designee shall initiate Clinical Reviews investigations in accordance with Physio Quality Work Instruction 8000087, Complaint Handling.

7.3.3.1.1 When a Clinical Review concludes that the use of the device may have caused or contributed to a death or serious injury, a representative from the CMC shall provide notification to the Adverse Event Group within 10 working days from the completion of the Clinical Review. The QRA Specialist or designee shall attach the notification to the complaint record.

7.3.3.1.2 A Clinical review shall be initiated when the following occur:

If the QRA Specialist or designee deems that a device malfunction or use error may have caused or contributed to a death or serious injury/serious illness

If the QRA Specialist or designee is unable to determine if a verified malfunction is reportable

A representative from Jolife’s Quality/Regulatory Department or designee sends a clinical review in the form of a memo to the QRA Specialist or designee that owns the complaint

7.4 Product Analysis

7.4.1 The Physio PAC investigator or designee shall complete investigations in accordance with Physio Quality Work Instruction 8000087, Complaint Handling in conjunction with Stryker Corporate Quality Work Instruction, CQI-PMS-001-07, Product Assessment Center (PAC).

7.4.1.1 All customer complaints should be utilized as an input to the tracking and trending process within the Nonconformance Work Instruction, 8000084, for further evaluation to determine if additional investigation is required within the CAPA process.

7.4.2 Device Non-Conformance History Review

7.4.2.1 The CQA Engineer or designee shall complete a device non-conformance history review for reportable complaints in accordance with Physio Quality Work Instruction 8000087, Complaint Handling.

7.4.2.2 A Device Non-Conformance History Review should be completed when a non-reportable complaint is entered into TrackWise.

7.4.3 Failure Analysis Center

7.4.3.1 Where applicable, the complaint investigation may include a product analysis by FAC, if and when the product is made available by the customer. Refer to Physio Quality System Work Instruction, 7000866, Failure Analysis Center. When product analysis is performed, the CQA Engineer shall include the appropriate analysis details in the complaint record.

7.4.4 Justification shall be documented when any complaint is not investigated.










7.4.5 Relevant information shall be exchanged between Physio and the external party when an investigation determines activities outside the organization contributed to the complaint.

7.5 Regulatory Reporting Review

7.5.1 All complaints shall be reviewed for reportability by a Physio QRA Specialist or designee in accordance with Physio Quality Work Instruction 7000362, Medical Device Reporting in conjunction with Stryker Corporate Work Instruction, CQI-PMS-001-04.

7.5.1.1 In countries for which Physio is not the license holder for the product that is being distributed, reporting of complaints to the regulating body in that country is the responsibility of the license holder. Physio shall maintain compliant records for these complaints, and shall include any reports that are produced by the license holder within the complaint record.

7.5.1.2 The assessment shall be completed in accordance to the countries reporting regulations.

7.5.1.3 Per quality agreement requirements, Physio shall submit MEDDEV vigilance reports to the EU Competent Authorities on behalf of Jolife AB (a wholly owned subsidiary of Physio).

7.5.1.3.1 +A copy of MEDDEV vigilance reports submitted by Physio on behalf of Jolife AB shall be submitted to the Jolife AB Notified Body (GL Nemko Presafe AS).+

7.5.2 Federal Aviation Administration (FAA)

7.5.2.1 All FAA, Physio Technical Standard Order (TSO) approved products shall be reviewed for reportability and documented within the complaint record by the QRA Specialist or designee.

7.5.2.2 An event shall be reported to the FAA as described in the Federal Aviation Administration Requirements Work Instruction, 7000378 when a Physio Technical Standard Order (TSO) approved product failed, malfunctioned or is defective and is determined to be:

responsible for a fire

responsible for the accumulation or circulation of toxic or noxious gasses in an airplane crew compartment or passenger cabin

7.5.3 Field Actions

7.5.3.1 The CMC and PAC shall adhere to Physio Quality System Work Instruction, 8000087, Product Complaints, in regards to Field Action Reports.

7.6 Closure

7.6.1 Investigation Record Closure

7.6.1.1 The Investigation Approver shall review the Investigation Record for approval to close the record per CQI-PMS-001-04, Complaint Management Center (CMC).

7.6.1.2 The Investigation Approver shall not be the same person as the Investigator.

7.6.2 Complaint Record Closure

7.6.2.1 Once associated Investigation Records, AER and associated Action Required Records are closed, the Complaint Record shall be reviewed and processed per CQI-PMS-001-04, Complaint Management Center (CMC). +Target for complaint record closure timeliness shall be 1 year or less. Complaints remaining open greater than 1 year shall have a documented rationale.+










7.6.3 Product Inquiry Closure

7.6.3.1 PI shall be reviewed and processed by the Reviewer to determine if customer feedback or product return was requested.

7.6.3.1.1 Once associated Complaint records, applicable Product Return Records and associated Action required Records are closed, the PI shall be closed by the QRA Specialist, or designee.

7.6.3.1.2 Refer to CQI-PMS-001-03, Complaint Intake Center (CIC).

7.6.4 Re-opening a Record

7.6.4.1 Refer to CQI-PMS-001-04, Complaint Management Center (CMC) for how to re-open records.

7.6.4.1.1 The complaint shall be entered in the TrackWise CHS system in accordance with this procedure, with all the relevant attachments and the legacy copy of the complaint attached to the CHS record, when the following requirements are met:

Legacy SmartSolve no longer allows CMC or PAC to re-open and update complaints.

A complaint or investigation, entered and recorded in legacy SmartSolve needs to be re-opened due to new or additional information that becomes available.

7.6.4.1.2 A Physio CIC, CMC representative, or designee shall re-open a complaint record/case when the following requirements in Stryker Corporate Complaint Handling Procedure are met:

New information is received (e.g., medical records, device return).

An error is identified.

Clarification is needed.

Upon request from a regulatory agency

Clerical updates

7.7 Data Monitoring, Analysis, and Evaluation

7.7.1 Complaints data shall be reviewed in accordance to the Corrective and Preventive Action Quality Procedure, 8000006 and Management Review Work Instruction, 8000035.

7.7.2 Sites managing complaints shall maintain metrics and monitor for trends in accordance with Physio Quality System Work Instruction, 8000087, Product Complaints Work Instruction.

document detail - stryker corporation · gmp requirements for medical devices and ivds (rdc 16,...

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