Design Completion Checklist Non Electromechanical Devices Template
The Design Completion Checklist Non Electromechanical Devices Template should be completed and evaluated upon satisfactory completion of the design phase of a product. Engineering is responsible for conducting a final evaluation of prototypes and changes, modifications, or corrections prior to transferring the product to Production/Manufacturing.
Once ENG107-2 DESIGN COMPLETION CHECKLIST FOR NON-ELECTROMECHANICAL DEVICES is complete, keep in mind that the design completion phase also will encompass evaluating that the product satisfies all regulatory requirements in all markets (domestic and international) that the product will be sold. Further, applications for any and all licenses, permits or approvals required (e.g., FDA Pre-market Approval, UL, or equivalent CSA) shall be completed.
Design Completion Checklist Non Electromechanical Devices Template Details
The Development Contracts Procedure ensures that contracts are written correctly, retained, and filed in an appropriate manner. Contract documents are important and must be received, processed and verified in a correct manner to avoid misunderstandings and disputes.
The construction Development Contracts Procedure applies to all project managers, supervisors, and project administrators. Contracts should define the agreement and responsibilities of all parties to the contract. (6 pages, 900 words)
Development Contracts Responsibilities:
The Project Manager should ensure that all of the contract documents agree exactly with the documents upon which the tender for the project was based. In the event of any discrepancies in the contract documents, they should inform the Division Manager, who will then direct an appropriate course of action to be taken.
The Device Master Record Contents Template is a listing of items that may appear in a Device Master Record. Upon completion of the design phase of a device, a formal document plan will be initiated and will be called the Device Master Record. The configuration and structure of the master record is determined by the Engineering and Manufacturing managers.
After agreement, the master record will be created, document numbers assigned, status of drawings indicated and the record approved by Engineering and Manufacturing. ENG104-1 DEVICE MASTER RECORDS CONTENTS includes categories such as manufacturing information, labeling and packaging, and control procedures and activities.
Upon compilation of all documents to be included in the Master Record, a Device Master Record Index Template should be prepared to identify all items in the record and location(s) of these records. ENG104-2 DEVICE MASTER RECORD INDEX includes descriptions such as product specification and product literature.
Upon completion of the design phase of a device, a formal document plan will be initiated and will be called the Device Master Record. The configuration and structure of the master record is determined by the Engineering and Manufacturing managers. After agreement, the master record will be created, document numbers assigned, status of drawings indicated and the record approved by Engineering and Manufacturing.
The Device Master Record Procedure prescribes the responsibilities for preparing Device Master Records (DMR) and to ensure the completeness of DMR Indexes (indices).
A Device Master Record should be prepared and maintained for all devices (products) manufactured or under development. All equipment specifically including medical devices manufactured by the company are covered under the Device Master Record Procedure. (14 pages, 2,077 words)
Device Master Record Definitions:
Device Master Record (DMR) – A compilation of records containing the description, design, formulation, specifications, complete manufacturing procedures, quality assurance requirements, and labeling of a finished device. In addition to the device specifications, a DMR contains documents that cover typical manufacturing activities including procurement, assembly, labeling, testing, and inspection and packaging.
DMR Index – Table of contents for the master record of a device; can contain information on the breakdown of the device into assemblies and/or manufacturing steps. Called a “document plan” during planning and early development of a new product.
The Device Specifications Template is a sample as to how to record complete specifications of the device. ENG104-3 DEVICE SPECIFICATION (EXAMPLE) is a specific document that briefly describes and gives all important details of the external and optionally internal characteristics of a device.
Generally a product specification will contain the device’s:
product trade and common name(s);
performance characteristics and theory of operation;
environmental limitations and product stability;
important components and formula (if applicable);
manufacturing cautions; and
user safety characteristics.
A preliminary device specification should be written at the beginning of a project and updated as the device is developed or modified. Specifications are usually developed by the marketing and product development departments with review and consultation by quality assurance, manufacturing, and other departments. The contents of the final specification must agree with the other elements of the device master record and with the actual device when it is manufactured.
The Drawing Schematics Procedure lists requirements for drawings and schematics.
Engineering Services will be responsible for preparing all required drawings and schematics to support product design, manufacturing, service, and maintenance and for use as illustrations in operation manuals.
The Drawing Schematics Procedure applies to all finished products and products under development. (2 pages, 284 words)
Engineering will evaluate each product and prepare the appropriate drawings and/or schematics as applicable. All drawings/schematics will be properly labeled for identification purposes.
The Electromechanical Devices Design Checklist Template should be completed and evaluated upon satisfactory completion of the design phase of a product. Engineering is responsible for conducting a final evaluation of prototypes and changes, modifications, or corrections prior to transferring the product to Production/Manufacturing.
Once ENG107-1 DESIGN COMPLETION CHECKLIST FOR ELECTROMECHANICAL DEVICES is complete, keep in mind that the design completion phase also will encompass evaluating that the product satisfies all regulatory requirements in all markets (domestic and international) that the product will be sold. Further, applications for any and all licenses, permits or approvals required (e.g., FDA Pre-market Approval, UL, or equivalent CSA) shall be completed.
Engineering Change Document Change Control Procedure
The Engineering Change Document Change Control Procedure outlines the steps and responsibilities to request changes to products or processes and the implementation of those changes to assure an orderly, controlled, and a 100% effective change to all aspects of the manufacture of a device and all related documentation.
The Control of changes to devices, processes, and the associated master records is one of the most important elements of a quality assurance system. Therefore, it is company policy that all changes must be made according to approved Engineering Change/Document Change Control Notices.
The Engineering Change Document Change Control Procedure applies to all manufacturing processes and products manufactured by the company. Specifically, Change Control applies to: components, including software; labeling and packaging; devices; processes; production equipment; manufacturing materials; and all associated documentation such as standard operating and quality assurance procedures, data forms, and product-specific documentation. These documents constitute the Device Master Record. Therefore much of the discussion herein is centered around the Device Master Record.
The procedures are to be followed from the time the master record is first released for production of a device for all changes to the in-process device or the associated manufacturing processes through implementation of changes to all appropriate documents. (8 pages, 1332 words)
Engineering Change Responsibilities:
All Personnel need to supply as much detail as they can with ENG102-1.
The Engineering Manager and the President will determine whether to schedule a management review of the proposal.
Engineering Change Document Change Control Procedure Activities
Request for Design and/or Process Changes
Engineering Change Notice and Document Change Control
Engineering Change Control Procedure References
ADM103 FILE AND RECORD MANAGEMENT
ENG101 DRAWINGS AND SCHEMATICS
Engineering Change Document Change Control Procedure Forms
Engineering Change Notice Document Change Control Template
Upon successful evaluation, design, development, testing and authorization of a change, an Engineering Change Notice Document Change Control Template will be completed to “order” the change and begin implementation.
The Engineering documentation section should have overall responsibility coordinating, scheduling, and executing documentation changes. When updating documentation the designated individuals will also be responsible for purging all originals and working copies of the obsolete documentation to avoid any confusion or misuse of the wrong document. A copy of the obsolete document will be retained and stored as appropriate for archive files.
Part I of ENG102-2 ENGINEERING CHANGE NOTICE/DOCUMENT CHANGE CONTROL will be completed, the form authorized, and a sequential ID assigned for tracking, logging, and filing purposes. To implement a change and ensure that all related documentation is updated, Part II must be completed.
Engineering Change Notice Document Change Control Template Details
A design review checklist should be constructed, as appropriate, using ENG108-1 PRODUCT DESIGN REVIEW CHECKLIST as a guide. The design review should consist of an evaluation of the design, assuring that each checklist item is adequately addressed. The design review checklist should include the following items:
Physical characteristics, constraints, and aesthetic specifications;
Compliance with regulatory requirements and national and international standards;
Labeling, including warnings, identification, and traceability, operating, and maintenance instructions;
Ease of installation, reliability, serviceability, and maintainability requirements;
Selection of materials, components, and sub-assemblies, including approved suppliers and availability; and more.
Review results from the Engineering Product Design Review Checklist Template should be documented and signed by designated individuals as complete and accurate. All changes made as a result of review findings should be documented. Reports should include conclusions and recommended follow-up and should be disseminated in a timely manner to appropriate organizational functions, including Top Management.
The Environmental Management Action Plan Template keeps track of the item, actions to be taken and specific steps, persons assigned, and completion date. Environmental Management involves proper hazardous waste management procedures. If the company does generate hazardous waste, detailed EPA and State regulations for hazardous waste management should be incorporated.
Any compliance concerns should be documented on the checklist and added to the ENV102-4 ENVIRONMENTAL MANAGEMENT ACTION PLAN. The Environmental Coordinator shall meet with department managers and the company’s officers to review compliance concerns and implement a plan to address or resolve each issue.
Environmental Management Action Plan Template Details
The protection and preservation of the environment is a fundamental concern to your company. It is important to maintain compliance with Environmental Protection Agency (EPA), State, and local environmental regulations and implement voluntary programs to minimize waste.
The Environmental Protection Procedure will provide methods for the evaluation and prevention of pollution in the workplace. It applies to all employees and departments of the company. (4 pages, 1068 words)
Environmental Protection Definitions:
Chlorofluorocarbons (CFCs) – A family of chemicals used in refrigerants and air conditioning and in consumer products. When released into the air, CFCs drift into the upper atmosphere where their chlorine components destroy ozone.
Waste minimization – Reduction of solid waste amounts through the use of techniques such as reusing items, minimizing the use of products that contain hazardous substances, using only what is required, etc.
The Construction Equipment Control Procedure provides for the purchase of necessary construction equipment and tools and to minimize the use and cost of rented equipment.
Construction equipment requirements should be planned, scheduled and controlled with the same consideration that is given to other aspects of the construction development process, such as labor. Use of construction company-owned equipment should be standard, and any outside equipment rentals should be controlled to ensure the use of and rental period for such equipment is kept to a minimum.
The Construction Equipment Control Procedure applies to all construction project managers, supervisors, and project administrators. (2 pages, 335 words)
Construction Equipment Control Responsibilities:
The construction Project Manager and Project Superintendent are jointly responsible for preparing a construction equipment list, a small tools list and an expendable tools list and for forwarding these lists to the construction Purchasing Department for action.
Construction Equipment Control Procedure Activities
Construction Company Owned Equipment and Small Tools
Responsible company officials who are in positions of authority in regulated firms have a primary legal duty to implement whatever measures are necessary to ensure that their products, facilities and operations are in compliance with the law. The law presumes these individuals are fully aware of their responsibilities.
As such, your company will not only ensure compliance with GMP but will plan and prepare for factory inspections by FDA auditors and will assist and coordinate the investigation to provide a smooth, timely process that accurately portrays your company’s operations.
The FDA Inspections Procedure outlines an inspection plan for FDA GMP audits of our factory.This statement applies to all factory inspections by the FDA and affects all employees involved with the inspection process. (16 pages, 3726 words)
FDA Inspections Definitions:
GMP – Good Manufacturing Practice.
Good Manufacturing Practices (GMP) regulation – Requires that manufacturers of medical devices intended for commercial distribution in the USA establish and follow a quality assurance program. See FD&C Act, section 520; also see 21 CFR 360j (f).
FDA Two-Track GMP Inspection Strategy Compliance Program Template
The FDA Two-Track GMP Inspection Strategy Compliance Program Template includes information regarding mandatory points to be evaluated, Track I and Track II inspections, and instructions for reviewing records. During the inspection, the investigator will record observations of areas inspected on form FDA 483. The areas to be inspected will depend on the circumstances of the investigation. For Class I devices, complaint files and MDR will usually be all that is investigated unless major problems are discovered.
The Two Track strategy requires a comprehensive GMP inspection (i.e., a complete systems audit of the quality assurance program) every four years and a limited GMP inspection at the intervening two year mark if, and only if, the firm at the two year mark meets the conditions specified in this Compliance Program.
FDA Two-Track GMP Inspection Strategy Compliance Program Template Details