GPMG’S MODULAR ISO 13485 QUALITY MANAGEMENT SYSTEM RISK MENT DESIGN M ANAGE CONTR OL ENT DOCUM L AINT C ONTRO COMPL G H ANDLINA LOGICAL AND COST EFFECTIVE APPROACHTO OBTAIN ISO 13485 CERTIFICATION ANDFDA QSR COMPLIANCE GLOBAL PACIFIC MANUFACTURING GROUP LLC
The termmodular has been used to describe a plethora ofWhat is a modular quality system?products. Therefore, the word modular evokesa variety of thoughts and reactions. GPMG usesthe term “modular” to describe a quality systemconsisting of a series of carefully crafted interlockingprocedures that have been grouped into logicalmodules that follow the ISO 13485 sections.Organizing the procedures in modules merelyprovides us, or our clients, the ability to install anentire system following an appropriate sequence.This sequence incorporates lessons learned aftermultiple site installations around the world. Thesystem modules also enables us to rapidly extractStandard Operating Procedures (SOP’s) needed to Throughout an installation process opportunitiesaddress a “gap” identified in an existing system. for improvement will become evident. Many of those opportunities can be immediately adoptedA quality system developed piece-meal often into the system content during installation.becomes a confusing web of overlappingdocuments difficult to maintain and consumes GPMG’s approach is to understand a company’svaluable time attempting to effectively train needs and identify any compliance gaps. We thenresources. However, by applying forethought to shape our base modular system to match yourthe varying needs of companies, and the regulatory organization. Because the GPMG modular system isenvironment in which they operate, a quality straight forward, many of our clients elect tosystem can be designed to be an asset not a burden. conduct the integration effort on their own, leveraging their own resources, and rely onGPMG’s approach to an effective system installation GPMG to challenge the system post integration.has always been viewing the project from amanufacturing perspective. The main reason being A quality system is merely the sum of all itsthat if a company is not competitive in today’s global operating procedures. GPMG has carefully createdeconomy a quality system becomes a moot point. each standard operating procedure in a manner that meets the applicable compliance requirementsThe ideal system installation is one that captures while maintaining the flexibility to efficiently adoptprocesses a company may have already developed, them into a particular organizational structuredocumented or otherwise. GPMG aligns any such and the activities a company may be engagedprocesses with the applicable regulatory space. (e.g. design, manufacture, distribution, etc). MODULAR SYSTEM’S ROOTS APPLICATIONS ADVANTAGES- Developed to expedite factory - Existing manufacturers - Implementation can follow a relocation projects. - New divisions or start-ups logical cost effective sequence- A solution for a need to rapidly - Distributors - Increased control over address system “gaps” identified - Brand-only companies implementation process during GPMG or FDA audits. outsourcing manufacturing - Simplified project management- To develop the ability to support - Contract design companies and reduced installation time the quality systems needs of - Contract manufacturers start-up companies who often face - Adaptable to varying resource and cost challenges. - Contract service providers organizational structures
How does GPMG install a complete system? The For this reason our focus during the development ofprocess begins by first gaining an understanding the modular system was on creating a frameworkof your company objectives, the nature of your that captures the fundamental areas of need withinproducts and services, and the markets in which every company. Then structure each procedure in ayou currently or intend to operate within (e.g. US, manner that allows for efficient expansion on eachEurope, Canada, etc.). process. The final core content of each standard operating procedure, in most cases, will remain veryIt is also important to understand any current or similar to the baseline.future product design activity the company is orwill be engaged in and the anticipated regulatory Example: The GPMG procedures governing Designpathways needed for product approval for various Control may remain virtually the same as thecountries (e.g. PMA, 510k, CE, etc.). baseline. However, the departmental titles and approval process flow will be adopted into aWhy is this important? The GPMG modular base company’s organization structure and policies. Thesystem is all inclusive. The system considers design, design phases, review content, and required areasmanufacture, distribution, etc. After gaining insight of expertise to adequately review a specific projectto your needs we extract the applicable operating will be the same under any scenario. How a projectprocedures and align them to match a particular is originated or requirements for internal approvalsituation. of a project will vary with each organization.Every company has a varying amounts of resourcesand different organizational structures. As an an existing system? GPMG typically will conduct a How does GPMG address compliance “gaps” withinexample, a start up company may have limited gap assessment of a company’s current operation tointernal resources and may leverage outside identify compliance gaps. In some cases, gaps mayresources or consultants. The internal resources have been previously identified during an audit by amay wear several “hats” within the organization. notified body or the FDA. Regardless of the means inLarger companies typically have an additional which an area of need is identified, one advantage oflayer(s) of managers for each department and will GPMG’s modular system is the individual proceduresbreak up departments into separate sub-groups. are flexible enough to be installed into an existingRegardless of the size of the company the underlying system with minimal effort.fundamental roles and areas of expertise remainbasically the same for most western companies (as These situations in fact are quite typical andshown in chart below). Many Asian companies may represent a large percentage of the installation workhave the same structure but departmental authority we perform around the world. Such scenarios werewill vary. also a major consideration during development of the modular system.to understand? The GPMG modular systemWhy is the organizational structure important for usis framed around this assumed organizational Assumed Organizational Structurestructure. Standard operating procedurescontain within them certain departmentalresponsibilities and approval flow / processes.The nature of various activities will demand Management Presidentvarying levels of relevant expertise having Representative CEOinput throughout an approval process. Theorganizational structure and the products acompany produces accounts for the greatesteffort expended on integrating the modular Research and Quality Assurance / Sales andquality system. Finance Operations Development Regulatory Affairs Marketing
Specifically, How is a modular system installed? System Gap AssessmentThe first step of system development and integrationis to understand the company’s overall businessobjectives and activities, such as product design,classification of the company’s products, and typeof services the company may offer. GPMG conductsa “Gap Assessment” of current activities and systems,including understanding any undocumentedprocesses. The gaps are measured against ISO 13485and FDA QSR requirements. The organizationalstructure and activities within the facility are alsodocumented during the assessment process. Quality Manual Development QUALITY MANAGEMENT Page 1 of 18 SYSTEM MANUAL ECN #Global Pacific Manufacturing Effectivity Date: QMSM Revision: A Group, LLC A quality management system manual is created1.0 Purpose and Scope encapsulating the company activities, the regulations Standard Operating Procedure and standards the company is committing to comply This quality management system manual (QMSM) specifies requirements and designates responsibility for processes conducted and products produced at [Company Name] facilities located in [Enter Location(s)]. Page Reference to any national or international standard implies the latest revision unless otherwise stated. Statistical Techniques ECN Conformance to these requirements is directed at achieving customer satisfaction by preventing nonconformity at all stages from design to distribution. with,Global Pacific Manufacturing structure, quality policy, the documentation Effect SOP 8-07 Revision: 12.0 References The policies in this Quality Management System Manual are based on the following regulations and standards and organizational responsibilities. Group, LLC as applicable: 1.0 Purpose 21 CFR Part 820: Food and Drug Administration Quality System Regulations (QSR) Medical Devices Act The purpose of this procedure is to provide established statistical methodologies to be Canadian Medical Device Regulations (CMDR) [Company Name] Sampling Plan(s), Quality Improvement, design assurance, prob Council Directive 93/42/EEC (6/1993): Medical Device Directive (MDD) analysis, and general data analysis. ISO 13485 (7/2003): Medical devices - Quality management systems - Requirements for regulatory purposes 2.0 Scope3.0 Terms and Definitions For the purposes of this Quality Management System Manual, the definitions and vocabulary listed and defined in FDA 21 CFR Part 820.3 annotated as necessary by the definitions and vocabulary listed in current published The user should have some statistical knowledge and have access to the literat revisions to EN ISO 13485, MDD 93/42/EEC, CMDR referenced in this procedure.4.0 Quality management system (QMS) 4.1 General requirements Where sampling is to be carried out for the purpose of establishing product characteris [Company Name] has implemented a quality management system which has: the acceptability of process capability, the sampling shall be based on established statis a) Identified the processes needed for the quality management system and their application throughout the organization b) Determined the sequence and interaction of these processes 3.0 Reference Documents c) Determined criteria and methods needed to ensure that both the operation and control of these processes are effective d) Ensured the availability of resources and information necessary to support the operation and Align Departmental(e.g., Statgraphics, Minitab, etc.) 3.1 3.2 Statistical Software Responsibilities Jurans Quality Control Handbook monitoring of these processes 3.3 SOP 8-08 Non-Conforming Material System e) Monitored, measured and analyzed these processes f) Implemented actions necessary to achieve planned results and maintain the effectiveness of these 3.4 SOP 8-10 Incoming Quality Assurance (IQA) processes 3.5 SOP 7-23 Process Validation Procedure The specific requirements are established and documented. Documents that define the product 3.6 QMSM Quality Management System ManualThe base GPMG modular system has made assumptions specifications, including manufacturing and quality assurance procedures and specifications for a medical device, or noting to the location of this information is established and maintained and 4.0 Responsibility/Authorityas to the organizational structure. As the system is considered to be the Device Master Record. 4.1 New Product Developmentemployed those assumptions are aligned with theConfidential:This document contains information that is the confidential and proprietary property of GPMG. Neither this document nor the information therein may be reproduced,used or distributed to or for the benefit of any third party without the prior written consent of GPMG. New Product Development (NPD) Engineering is responsible for using statis for defining the product characteristics and leading the Project Teamspecific organizational structure and departmental development.titles, areas of responsibility, and approval flow. 4.2 Quality Assurance Quality Assurance is responsible for using statistical analysis for product cDepending on the situation some of the baseline design validation / verificationresponsibilities will be either combined or broken into 4.3 Process Engineering Process Engineering is responsible for verifying the acceptability of processadditional departmental groups or sub-groups. the process/product specification/characteristics, using statistical methodolo 4.4 Quality Engineering Quality Engineering is responsible for establishing Inspection Plans and consistent with the requirements and characteristics of the device/part. T specification(s) are met, using statistical methodologies. Confidential:This document contains information that is the confidential and proprietary property of GPMG. Neither this document nor the inform
Group, LLC 1.0 Purpose To establish the handling of device complaints by [Company Name] in compliance with the Food and Drug Specification Number Format and Linkage Administration’s (FDA) 21 CFR 820. 2.0 Scope This procedure applies to all devices manufactured and/or commercially distributed by [Company Name]. 3.0 Applicable Documents The GPMG base modular system utilizes a GPMG 1. FORM 8-05 MDR Decision Tree numbering system to identify and cross link 2. SOP 8-02 Complaint Trending procedures. When a company elects to use their 3. SOP 8-03 Recall / Advisory Notice 4. SOP 8-04 Corrective and Preventive Action System own unique numbering system GPMG will create a 5. SOP 8-06 Medical Device Reports (MDRs) temporary spreadsheet cross referencing the two Standard Operating Procedure 6. FORM 9-01 Vigilance Decision Tree: Incidents numbering systems. The next step is to simply swap Syste Complaint Handling 7. FORM 9-03 Incident Decision Tree: Canada 8. SOP 8-14 Vigilance out the numbering references in a controlled manner Global Pacific Manufacturing 9. QMSM Quality Management System Manual so the final documents remain properly linked to each Revisio Group, LLC SOP 8-01 4.0 Definitions other. 10.1 If the complaint evaluation determines that an investiga conducted by Quality Assurance and Engineering or oth 4.1 Complaint Report - Any written, electronic, or oral communication that alleges one or more documented on the investigation section of the complaint for deficiencies related to identity, quality, durability, reliability, safety, effectiveness or performance of 10.2 Quality assurance will determine if the failure of a device o one or more a device after it is released for distribution. A Complaint Report contains one or more failure constitutes a reportable eve remedial action or the Complaints or Incidents. Incident – (Same as Complaint) prevent an unreasonable risk of substantial harm to the public 10.3 If testing is required, investigations wherever possible shou 4.2 Complaint File Number - The number that uniquely identifies each individual complaint formode Effect Analysis, laboratory tests, etc analysis, failure a commercialized device. The number consists of numeric, automatically assigned by the computerized failure. A device history record review may also be inclu complaint system. specification, a determination must be documented as to t device to meet a specification must include corrective ac 4.3 Integrate Specific / Unique Process Steps Lot Number - The unique number assigned to all production. For [COMPANY NAME], the numberof the decision maker, why no c rationale, with the name action(s) will be handled through the Corrective Action Proc is coded to indicate the manufacturing date (year, month, day, and shift). 10.4 A complaint investigation must include the following eleme 4.4 Device History Record - A compilation of records containing the production history ofConducted Testing a finished device. Testing Results and ConclusionsGPMG aligns the modular standard operatingfrom its original place of manufacturing, and makescomplaint is confirmed 4.5 Distributor - Furthers the marketing of a device Determination if the 11.0 Procedure: Closing the Complaintprocedures with final delivery or sale to the ultimate user such as a hospital, clinic or physician the specific details of how a 11.1 A complaint file may be closed when the complaint hasparticular process is executed within of acompany. 4.6 Evaluate - The careful analysis a device and related documents to confirm a reported complaint and, corrective action(s) have been initiated. The complaint su investigation. If a corrective action has been initiated, the CEvery company will have a unique methods of whenever possible, determine root cause and corrective action(s). referenced in the complaint summary. Minimum required do MDR Decision Tree, Investigation record and when appcarrying out a specific task. The modular system is Confidential:This document contains information that is the confidential and proprietary property of GPMG. Neither this document nor the information therein may be reproduced, Decision tree, Medwatch Form, Baseline and IFU. Any oth used or distributed to or for the benefit of any third party without the prior written consent of GPMG. also be included.structured to accommodate these modifications with 11.2 Complaint status shall be updated and completed in theminimal effort. complaint was closed will be entered in the data base. 11.3 A closed complaint file is retained per the Record Retention 12.0 Procedure: Reviewing the Complaint 12.1 The review shall be done in a timely manner after the clos days). 12.2 The review must be performed by a person with adequate cli 12.3 The purpose of the review is to determine if there is agree MDR, Vigilance decision trees, investigation, conclusion and 12.4 If the review is successful, the reviewer shall sign and date th 12.5 If any issues are found in the complaint file during the revi additional information shall be added to the complaint file. Facility and Process Considerations 12.6 When the review is completed, the computer database shall as ‘reviewed’. This may be done by entering the date that the 13.0 Procedure: Management Review Each facility will have unique considerations to Confidential:This document contains information that is the confidential and proprietary property of GPMG. Neither th used or distributed to or for the benefit of any third party without the prior written consent of GPMG. incorporate into the quality management system such as environmental controls for clean rooms, controls for internal laboratories, and unique controls for various types of process equipment. GPMG has a broad range of procedures in addition to the baseline modular system that can be easily integrated with the quality management system.
Project Management GPMG has applied the lessons learned from multiple global quality system installations to develop an optimal approach to system installation. The installation sequence and priorities, resource training and development, and the transition from installation to utilization are measured and documented. All activities, action items, resource requirements, milestones, and time lines are controlled via detailed project charts. Project team(s) meet weekly to discuss pressing action items. Team members and management stay informed through meeting minutes published weekly. Quality System Modules ISO 13485 Sections: 4.0, 5.0, and 6.0 Module # 2 Quality Management System Manual Documentation Requirements, Management Module #1 Responsibility, and Resource Management ISO 13485 Section 7.0 ISO 13485 Section 8 Module # 3 Module # 4 Product Realization Measurement, Analysis, and Improvement Base System Contents Key System Elements 1 - Quality System Manual Document Control Module # 1 Record Retention #1Module Device Master Records Management Responsibility 10 - Standard Operating Procedures Module # 2 Resource Management 4 - Related FormsModule #2 Design Control Risk Management Design and Process Validation 29 - Standard Operating Procedures Module # 3 Product Labeling and Identification 14 - Related Forms #3 Complaint HandlingModule Medical Device Reporting Statistical Analysis 12 - Standard Operating Procedures Corrective and Preventative Action Module # 4 8 - Related Forms Non-Conforming MaterialsModule #4 Process Controls Supplier Approval Process Global Pacific Manufacturing Group LLC www.gpacmfg.com tel. 202.380.9380