*.*Purpose

This QCP establishes the procedures to be followed for requesting and documenting changes to Mercury Medical products (e.g., design, components, etc.), manufacturing processes (e.g., BOM, BR, etc.) and production equipment, packaging, labeling and quality system documentation (e.g., procedures, work instructions, inspection/test methods, etc.).

2.0Policy

A documented Engineering Change Order (ECO) process ensures products are manufactured or assembled in a consistent manner. A responsible individual representing each affected department receives notification of the ECO contents so they may respond to changes in their products and processes. The ECO also provides a means for tracking changes and/or improvements to Mercury Medical products and processes and ensuring compliance with regulatory requirements.

3.0Application/Responsibilities

Any individual may suggest a change to any Mercury Medical product or process. Changes shall be reviewed and approved by appropriate functional department personnel affected by and/or involved in the change process. Responsibilities or representative functions may include responsibilities related to, but not limited to the following:

Engineering ensures that changes are technically feasible, do not affect the safety or effectiveness of the device, and that they comply with applicable standards and regulations. Proposed changes are tested and documented prior to implementation.

Procurement secures material and components identified by Engineering and required to implement any change. Procurement obtains and reports information concerning availability, lead times, and material on order.

Marketing ensures that all applicable changes are incorporated into advertisements, catalogs, price lists, labels, and so forth. Sales personnel are informed of changes to product function or appearance and receive training, as required, for any change or new product.

Manufacturing ensures that all products are manufactured to current revision levels and that rework is conducted on “WIP” (Work In Progress) and “Finished” inventory, as required.

Quality ensures that purchased parts conform to applicable specifications and manufactured products meet company quality and performance standards. The Quality department controls and distributes the ECO package and ensures that the package is complete.

4.0Definitions

Batch Record/Work Order: A document that details the production steps for an assembly or finished device.

Bill of Material (BOM): A list of materials used in the production of an assembly or finished device.

Change History: This is the historical information for a document(s). The change history includes, at a minimum, a description of the change(s), identification of any affected documents, the signature and date of the approving individual(s), and the date the change becomes effective. The change history for documents is detailed on the Document Change Request Form. Additionally, a change history summary is included on Quality Control Procedures in the Revisions section.

Contraindication: Describes situations in which the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits.

Design History File (DHF): A compilation of, or indexed reference to, the records which describe the design history for a finished device.

Device Master Record (DMR)/Medical Device File (MDF): A compilation of records including: design formulation, specifications, completed manufacturing procedures, QA requirements, labeling of a finished product which convert device components into finished product.

Dimensional Specifications: The physical size and shape of the device. Such specifications may include the length, width, thickness, or diameter of a device, as well as the location of a part or component of the device.

Energy Type: The type of power input to or output from the device. Examples of a change in energy type or character would be a change from AC to battery power (input) or a change from ionizing radiation to ultrasound to measure a property of the body (output).

Engineering Change Order (ECO) Form: This is the document used to request and document changes to Mercury Medical products, manufacturing processes, labeling and quality system documentation.

Environmental Specifications: The (range of) acceptable levels of environmental parameters or operating conditions under which the device will perform safely and effectively. Examples of changes in environmental specifications are expanding the acceptable temperature range in which the device will operate properly or hardening the device to significantly higher levels of electromagnetic interference.

Human Factors of Patient/User Interface: The human factors of the patient or user interface refer to the way in which the device and the patient or user interact. This includes the way in which the device presents alarms to the user, the layout of the control panel, the mode of presentation of information to the user or patient, and the way in which the device physically interacts with the user and/or patient (e.g., the way in which a CPAP mask attaches to a patient’s face, or the way a surgical instrument is designed to fit in a surgeon’s hand).

Indications for Use: The disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.

Intended Use: The general purpose of the device or its function and encompasses the indications for use.

Internal User’s Manual (User’s Guide/Reference Manual): (1) (ISO) Documentation related to use of the ERP system that describes how to use a functional unit. It may include a description of the rights and responsibilities of the user, the owner, and the supplier of the unit. (2) Instructions for using the functions of the system to obtain desired results from the software system.

Material Formulation: The base formulation of a polymer, alloy, etc., plus any additives, colors, etc., used to establish a property or the stability of the material. This does not include processing aids, mold release agents, residual contaminants, or other manufacturing aids that are not intended to be a part of the material, but that could be present as impurities on the final device. An example of a change in material formulation would be a change from a series 300 stainless steel to a series 400 stainless steel. Another example of a change in material formulation would be the addition or subtraction of a chemical or compound to or from a polymer.

Material Type: The generic name of the material from which the device is manufactured. An example of a material type change would be the change from natural latex rubber to synthetic rubber.

Operating Principle: The mode of operation or mechanism of action through which a device fulfills (or achieves) its intended use.

Performance Specifications: The performance characteristics of a device as listed in device labeling or in finished product release specifications. Some examples of performance specifications are measurement accuracy, output accuracy, energy output level, and stability criteria.

Precautions: Describes any special care to be exercised by a practitioner or patient for the safe and effective use of a device.

Quality Plan: A document setting out the specific quality practices, resources and sequence of activities relevant to a particular product, service, or contractor project.

Technical File: A compilation of technical documentation that documents that a device/device family meets the essential principles/requirements for performance and safety. The Technical File may include or refer to detailed information about the design, function, use, manufacture, claims, clinical, etc. of a medical device.

User Interface: A device user interface includes all points of interaction between the product and the user, including elements such as displays, controls, packaging, product labels, and directions for use.

Warnings: Describes serious adverse reactions and potential safety hazards that can occur in the proper use or misuse of a device, along with consequent limitations in use and mitigating steps to take if they occur.

5.0Reference Documents

QCF 02.3-1 Engineering Change Order Form

QCF 02.3-2 Engineering Change Order Log

QCF 02.3-3 Engineering Change/Project Plan

QCF 02.3-4 Equivalence Checklist

QCP 01.3 Employee Training

QCP 02.1 Design Control

QCP 02.2 Process Validation

QCP 02.4 Temporary Process Deviation Request

QCP 03.2 Document Control

QCP 03.4 CE Technical File

QCP 03.5 Clinical Evaluation

QCP 03.6 Biological Evaluation

QCP 06.1 Production and Process Controls

QCP 06.5 Manufacturing Process Rework/Rebox

QCP 06.6 Manufacturing Process Reconfigure

QCP 10.1 Labeling Generation and Approval

QCP 10.3 Medical Device Labeling Requirements

QCP 12.1 Device Master Records and Device History Records

QCP 16.1 Retention Record Storage Policies and Procedure

QCP 16.2 Electronic Media Control

QCP 21.0 Risk Management

QCP 25.0 Product Specification Sheet

QCP 29.1 Work Order / Batch Record Generation

Appendix I Engineering Change Order Flowchart

Appendix II Flowchart A – Labeling Change

Appendix III Flowchart B – Technology, Engineering or Performance Change

Appendix IV Flowchart C – Materials Change

Appendix V Flowchart D – When to File a 510(k) After Change to a Legally Marketed Device

Mercury Medical Quality Manual

FDA’s Deciding When to Submit a 510(k) for a Change to an Existing Device

6.0Procedures

Because many changes occur in the evolution of a device, changes should be evaluated for their effect on device safety and effectiveness (i.e., risk) and their impact (i.e., significance/harm) on previously cleared devices. Changes should be assessed individually and collectively with other changes to determine if a regulatory submission (e.g., Medical Device License, MDL Fax Back Form, FDA 510k, etc.) or notification (e.g., Notified Body, Authorized Representative, etc.) and/or design control project is needed, as applicable.

Any changes to a device’s design (DMR/MDF) will require an evaluation of the change to determine its significance and to determine if a regulatory submission or notification and/or a new design control project is necessary. A regulatory submission must be submitted, and a new design control project initiated when:

The device is one that the person currently has in commercial distribution or is re-introducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute examples of significant changes or modifications that may require a regulatory submission and/or new design control project:

A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

A major change or modification in the intended use of the device.

Note: Changes requiring some type of regulatory submission shall not be implemented until authorization has been given by the respective regulatory authorities.

Changes made to a device shall be verified through testing or engineering analysis to determine if the change adversely affects the safety or effectiveness of the device. Changes affecting product design are verified and/or validated as acceptable prior to implementation. Verification / validation activities shall be documented and considered as part of the device design history file.

6.1 A New Document or a Change to an Existing Document

Any employee may initiate a request for a change. Changes may include, but are not limited to, changes in:

Product design · Production equipment

Materials · Inspection & testing processes

Labeling · Quality system documentation

Suppliers · Operation of the quality management system

Production processes

6.2Initiate ECO form

The Requester of a change shall initiate the change process by completing section A of the ECO form. Copies of redlined, marked-up, or other supporting documents should be attached to the ECO form, as applicable.

The Requester of the change shall provide a complete description of the requested change(s) with a copy of the redlined document and any supporting information attached, as applicable. The reason for change shall also be clearly documented (e.g., result of market evaluation, customer request, complaint/adverse event, nonconformance, corrective action, regulatory requirement, product enhancement, process improvement, audit observation, etc.). The reason should include enough information to fully understand the rational for the change(s) and any significant risks that the ECO is addressing.

The Requester shall document the reason code in section B of the ECO form; document the change pathway on the appropriate change flowchart(s); and sign and date the flow-chart(s). Reference the flowcharts in Appendix II-IV and FDA’s guidance document for assistance in determining the change pathway.

NOTE: The Equivalence Checklist may be used to assist in determining the significance of a change in Technology, Engineering and/or Performance as well as Material changes and justifying the ECO route rather than the need for a new design control project.

The ECO form and any attached documentation shall be forwarded to the Document Control Specialist for processing.

6.3Review and Evaluate Requested Change

In accordance with the Document Control procedure, the Document Control Specialist shall identify the minimum approving authorities and document such in section C of the ECO form.

The requested change shall then be reviewed by the designated authorities independently or via an ECO meeting to determine the significance of the change and to confirm the change pathway. Options include:

Design Control Project.

Engineering Change; or

Documentation Only.

The review and approval of more significant changes should be handled via an ECO meeting. The Requester of the change is responsible for coordinating the ECO meeting as applicable. Minor changes or those requiring only minimal action may be routed for independent review and approval.

6.4Requested Change Approved or Disapproved

Designated approving authorities shall document agreement or disagreement with the proposed change(s) by signing and dating the ECO form in section C.

If the change is rejected, the reason for rejection or condition(s) for approval shall be documented on the ECO form. If the change is rejected, the ECO shall be returned to the Requester of the change.

6.5Design Control Project

If the change requires initiation of a design control project (e.g., 510k), the ECO should be voided, and Design Control procedures shall be followed.

6.6Documentation Only

If the change is dispositioned as a change in documentation only (i.e., the change does not have any effect on product safety or effectiveness), the Document Control Specialist shall assign an ECO number to the ECO form from the ECO Log. Responsible individuals shall then identify any additional documents affected by the change, provide a brief description of the change needed to each affected document, and assign responsibility for implementation of the change. The above information shall be documented on the ECO form in sections E, F, G.

NOTE: All documentation changes will require verification – i.e., document review and approval in section F. Section H is not applicable.

Assigned personnel shall make the necessary changes to documents. When changes have been made to documents and completion dates recorded in section G, approvals shall be documented in section I of the ECO form. The Document Control Specialist shall update any required indexes, logs, ftp-sites and assign an effective date for implementation of the change in section J of the ECO form, update the ECO log and sign the form indicating that all actions have been completed.

6.7Engineering Change

The Document Control Specialist shall assign an ECO number for the change from the ECO log and document such on the ECO form.

6.7.1Engineering Change Plan

During the ECO meeting, or independently, personnel shall:

1.Identify what to do with any material/product affected by the change in section D of the ECO form.

2.Identify the actions/tasks that need to be completed as a result of the proposed change(s) in section E of the ECO form. Actions/tasks required shall take into account the risk and impact associated with the change. A risk assessment shall be documented in each ECO and a justification shall be included if there is no change to the risk management files. An FMEA review should be performed to ensure all risks associated with both internal processes as well as supplier processes are captured or updated if needed.

3.Identify verification and/or validation activities required to confirm the effectiveness of the change in section F of the ECO form and make sure to include these activities in section G of the ECO form. At a minimum, verification shall include review and approval of the document(s).

NOTE: If the change will require a number of changes to documents, verification and/or validation is needed, qualification of suppliers is needed, etc., the Engineering Change/Project Plan Form may be used to assist in managing the ECO process and identifying the tasks/actions that need to occur for input into section G of the ECO form.

4.Upon review of the questions in section E of the ECO form and any verification and/or validation activities identified in section F, complete section G of the ECO form. This will require identifying the tasks/actions required to address each “YES” answer in section E. This includes documenting the following:

Corresponding task list code number (from section E)

Output Document (i.e., affected document – e.g., QCP, WI, BR, BOM, ASL, Risk Assessment, Drawing, PPS, PSS, DFU, etc.)

Responsible personnel – i.e., whom actions/tasks have been assigned to

Action/task to be completed (i.e. action required and/or description of the change – e.g. add new component/material, update drawing, evaluate supplier, assess biocompatibility, develop performance test protocol, verify dimensions, procure new test fixture/mold and verify tooling dimensions, validate process, revise or develop procedure/work instruction, add language/symbols to labeling, assess risk and update risk analysis, create PSS, develop inspection form, notify regulatory authorities, etc.)

Revision (From/To), as applicable

When complete, a senior member of QA or designate shall review the ECO to ensure that the actions indicated as required in section E are accurate and comprehensive for the change(s) and consistent with the tasks identified and assigned in section G of the ECO form.

Assigned personnel shall complete and/or make the necessary changes to documents, perform testing, etc., as indicated in section G and provide to the Document Control Specialist when complete. The complete date shall then be added for the action item.

6.7.2Review of Verification/Validation Results

When all activities have been completed, the Document Control Specialist shall route the ECO and all affected documents to approving individuals for approval. Alternatively, an ECO meeting may be called to review and evaluate completion of tasks and approve or disapprove implementation of the change. All required documentation shall be brought to the meeting.

Designated approving authorities shall review all documentation to ensure all required tasks have been completed. Where/when appropriate, verification and/or validation results shall be reviewed to determine whether the change is effective and whether the change will have an adverse effect on the finished device. Verification/validation references, as appropriate, and results shall be documented in section H of the ECO form (e.g., Test Protocol and Report Numbers, FMEA #, etc.).

If results show the change to be effective and to have no adverse effect on the finished product, personnel shall document approval to implement the change in Section I of the ECO form. If verification and/or validation activities show that the change is not effective and/or that it has an adverse effect on the finished product, an action plan shall be identified and documented in Section H of the ECO form to document the course of action.

6.7.3 Assign Effective Date and Implement Change

Once final approval is complete, the Document Control Specialist shall assign an effective date for the change in section J of the ECO form and update the ECO log. If the change needs to be implemented not sooner than a specific date or lot number (i.e., product change), such will be indicated. The change shall be implemented as needed in accordance with the Document Control procedure – e.g., Notice of New Issue/Revision.

6.7.4 Post-Implementation Steps

Some activities may be completed post-implementation and prior to distribution. These activities shall be completed by responsible personnel within 10 working days if possible, of the ECO effective date. This includes actions such as GUDID Submission/Update, Canadian License Amendment, update of the Device Master Record Log, update of indexes, updates to Citrix, approval of artwork samples, updates to the website and update to a distributor or importer QA Agreement, etc.

Upon completion, the ECO cover sheet and flowcharts are to be scanned and stored on the network.

Training to new/revised procedures, etc. shall be performed as needed in accordance with the Employee Training procedure.

6.8 Retain Records

All completed ECO forms and supporting documentation shall be maintained in accordance with record retention procedures.

7.0Revisions

Revision Record

Rev No.

Date

ECO No.

Description

1

---

---

2

---

---

3

08/10/99

---

Reformatted document to new standard; numerous editorial changes. Purpose, Policy, and Application are restated for clarity. ECO form redesigned; designation changed to QCF 2.3-1. Instructions rewritten for clarity. New document routing form implemented, QCF 2.3-2; routing, review & comment, signature and distribution instructions rewritten. Revision section added.

4

01/3/00

--

Added Definitions to EQUIPMENT /SERIAL #:

ISO 5356 15mm Plug Gauge_

CAL DUE DATE: CAL DUE DATE

Section 4.0; revised Section 5.4 to clarify approval process. Added QCF 2.3-3 Designation of Approval Authority.

5

06/12/00

---

Added FDA and ISO references to Sec. 2.

6

10/13/00

---

All changes made are referenced in CAR #0240-00 per ISO Trial Audit dated 8/10/00.

7

04/12/01

---

Changed “Director of Operations” to “Director of Materials Management” in Sec. 5.4.2; added “posting Quality System documents in the designated electronic file” to Sec. 5.5.

8

10/24/02

---

Change Purchasing to “Procurement”. Change Sales/Marketing to Product Manager. Correct typographical errors. Update chart of Minimal Approvals to reflect changes in corporate personnel structure.

9

07/08/03

---

Removed Sr. Engineer for minimum approvals in Sec. 5.4.2.

10

10/11/03

---

Revised all references in this procedure from ISO 9001/EN46001 to ISO 13485: 1996.

11

10/31/03

---

Eliminated all reference to Homecare in this Procedure. Also added “Procurement” in Product Labeling in the table of Section 5.4.2. Changed 501(k) in Section 5.2.2 to 510(k). Added “for Canada” in Sec. 2.0. Added last sentence in Sec. 5.0

12

11/26/03

---

Added last sentence in Sec. 5.0 reading, “Where timeliness of small production lots are important, a red-line copy for special assemblies may be used in the interim of the ECO approval”.

13

12/31/03

---

Added copy “with Temporary Deviation Request (TDR) form . . .” to Section 5.0.

14

04/15/05

---

Completely revamped ECO procedure and ECO form to adequately meet FDA change control requirements.

15

06/16/05

---

Added copy (e.g., new hose assembly) to Sec. 6.5, 4th paragraph and deleted “and completion of section D of the ECO form is not required.” In Sec. 6.7, 1st paragraph added, “is dispositioned as” also “additional” instead of “and all”.

16

03/30/06

---

Revised procedure and associated form for clarity, efficiency and effectiveness. Archived QCF 3.2-1 Document Change Request Log, QCF 3.2-2 Document Change Request Form and QCF 10.1-1 Label / Labeling Approval Form. Added appropriate charts (A, B, C and D) to eliminate need to refer to FDA Guidance Document for change disposition. Revised ECO form for clarity, to correspond with revised procedure, and added reason codes.

17

04/23/07

5108*

Changed wording of AS400 to I-Series/AS/400. Added QCP 10.3 to Section 5.0. Removed ISD (part of old ASW system) from paragraph titled Internal User’s Manual.

18

09/18/07

5256

Section 6.8, Added, “Upon completion, ECO cover sheet and flowcharts are to be scanned and stored on the network”.

19

12/05/07

5325

Changed wording of Documentation Compliance Specialist to Document Control Specialist. Changed section 6.0 to clarify regulatory submission/notification requirements. Removed “A copy of the ECO will also be retained with the design history file.” from section 6.7.

20

07/01/18

7614

QCF 02.1 Procedure: Update sections 6.5, 6.6 and 6.8 to more clearly document the change control process and align with changes made to the ECO form. The requirement to complete the flowchart(s) in Appendix II-IV has been deleted. These charts may still be used for guidance.

QCF 02.3-1 Form: The ECO form has been updated to more clearly document the assessment of adverse effect; to add more reason codes for change and the ability to select more than one box as applicable; to update the list of questions in section C to more clearly address regulatory requirements; and to add an area for the Document Specialist to document update of ECO Log and required indexes, logs, ftp-site, etc.

21

05/20/19

7826

Removed references to I-Series/AS/400 and replaced with ERP

22

06/20/20

8023

Allow administrative activities to be performed within 10 days after the effective date but prior to distribution (Reference Section 6.8).

23

08/29/20

8066

Update to address 2020 internal audit observations #98-101.

24

02/24/22

8313

Updates for ver/vel and risk management process requirements associated with 2021 audit NCRs 213****-******-N3, N4

Addition of definitions per 2017 FDA Guidance Document. Addition of 2 new forms: QCF 02.3-3 and QCF 02.3-4. Update of flowcharts. General update for clarity.

* Added ECO column.

ENGINEERING CHANGE ORDER FLOW

APPENDIX II

FLOWCHART A - IS IT A LABELING CHANGE?

Labeling Change Examples

Change: The manufacturer of a device adds a precaution stating that the device must be properly sterilized prior to use for patient safety. The modified labeling does not modify the previously validated cleaning, disinfection, or sterilization instructions.

Relevant questions:

Is it a change in the indications for use statement? No. This is not a change in the indications for use statement of the device.

Is it a change in warnings or precautions? Yes.

Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks? No. The added precaution simply emphasizes proper sterilization and does not affect the device’s risk profile.

Decision: ECO.

Change: The manufacturer adds a foreign language translation of the directions for use to a device’s labeling. The translation does not change the meaning of the instructions.

Relevant questions:

Is it a change in the indications for use statement? No. This is not a change in the indications for use statement of the device.

Could the change affect the directions for use of the device? Yes.

Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks? No. As long as the translation does not change the meaning of the instructions, this change would not affect the device’s risk profile.

Decision: ECO.

Change: The directions for use of a catheter guidewire are modified to provide instructions on how to access different types of vasculatures that were not previously addressed in the labeling.

Relevant questions:

Is it a change in the indications for use statement? No. This is not a change in the indications for use statement of the device.

Could the change affect the directions for use of the device? Yes.

Does the change describe a new disease, condition, or patient population that the device is intended for use in diagnosing, treating, preventing, curing or mitigating? No. The guidewire is intended for use in the treatment of similar patient populations with the same diseases, even if the access points differ.

Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks? Yes. The revised instructions suggest that the device can be used in new vasculature, which would be considered an expansion of the device’s indications for use. A risk-based assessment identifies that the new vasculature is more tortuous and significantly increases the risk of several device failure modes, which could significantly affect safety and effectiveness.

Decision: New Design Project.

Change: The original directions for use for a surgical laser intended to treat stones in the urinary tract only included instructions on lithotripsy modes. The instructions are modified to provide additional instructions on the existing settings for lithotripsy on the cleared device and does not modify instructions regarding compatible procedures or instruments.

Relevant questions:

Is it a change in the indications for use statement? No. This is not a change in the indications for use statement of the device.

Could

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