Quality Management System Services

Our hands-on methodology bridges the gap between complex global regulations and pragmatic, cost effective implementation. We specialize in creating scalable quality management systems to ensure efficiency, precision and excellence at every stage of the operation. We don't just know what to do, but also how to do it effectively.

Services Include:

General Services

Interim Organization Leadership
Project Management and Program Leadership
Organization Assessment
Assistance with interviewing and hiring of personnel
Provision of interim experienced Quality and Regulatory staff

Creation of a phase-appropriate Quality Management System (QMS) suitable for the size and complexity of your organization
Document and Record Control processes
Assistance with the selection and implementation of an eQMS system
Creation of processes, policies and procedures
Data Integrity
Part 11 Compliance for Electronic Records and Signatures
Integration, harmonization and optimization of QMS processes
Establishment of training programs including identification of training requirements, and evidence of comprehension / learning
Provision of comprehensive GMP training & annual refresher training
In-depth QMS process and procedure training

Quality Management Systems

Design and Development

Design and Development Planning
Documenting Intended Uses and User Needs
Design Inputs, including regulatory requirements as inputs and the use of Common Specifications and Harmonized Standards
Design Outputs with linkage to Design Transfer
Design Verification plans, protocols, execution & reports
Design Validation plans, protocols, execution & reports
Design Review
Design Transfer (joint activities in R&D and Manufacturing)
Design and Development Documentation, formerly called Design History File (DHF)

Risk Management

Requirements and expectations aligned with US FDA QMSR, EU MDR / IVDR and ISO standards
Risk Management processes throughout the product lifecycle
Risk Management Tools such as Risk Management Plans, Clinical Hazards List, Hazard Analysis, Failure Modes and Effects Analysis (FMEA), and others
Advisory Services for Risk - Benefit Analysis and the Risk Management Report, working in conjunction with your Medical Director
Risk Management Review process and use of the Risk Management File throughout the product lifecycle
Use of Risk Management for QMS risk-based approach decision making and cost savings

Note: J Michener Whipple & Partners LLC does not provide product Design Engineering services, and will not create product specifications or drawings.

Design Transfer

Best practices in Design Transfer planning, execution and documentation, including:
- Manufacturing and resource plans (In-source, Outsource)
- Product markets to be served and Labeling requirements
- Facilities, Utilities and Equipment requirements
- Comprehensive Product Master File / Product Specification File / Device Master Record / Medical Device File (Design Outputs)
- Risk Management
- Initial Supplier Evaluation and Qualification
- Process Characterization, Qualification and Validation
- Test Methods and Test Method Validation
- First Article Inspection
- Employee Training and Competence
- Manufacturing and Distribution readiness
- Commercialization readiness including Servicing and Customer Training, as required
- Post-Market readiness
- Pilot production

Regulatory Services

Determination of required licenses an registrations
Documented Regulatory processes for the entire product lifecycle
Linkage of regulatory processes to Clinical Investigation, Design and Development, Change Control, and Post-Market activities
Determination of global product pathways, submission requirements and potential timelines
Global strategies in alignment with marketing plans, product reimbursement rates, population needs and market authorization requirements
Assistance with determining predicate devices
Assistance with creation and submission of documents via eSTAR (electronic Submission Template And Resource) for pre-market approvals and supplemental updates

Supply Chain Processes

Outsourcing and Purchasing Controls

Production and Process Controls
- Optimized Process Flow and Material Controls
- Incoming Inspection, Work-In-Process, Final Acceptance and Product Release processes
- Statistical Process Controls and Statistical Techniques
- Cleanroom Operations
- Sterilization processes
- Production ramp-up, volume increases and optimization
- Re-validation of processes
- Production performance metrics and key performance indicators (KPI) for Management Review
Facilities and Equipment Calibration and Maintenance
- Environmental Controls
- Contamination Controls
- Calibration processes
- Out of Tolerance and Out of Specification
- Re-validation of facilities and equipment
Packaging and Labeling processes
Deviations & Nonconforming Materials, including returned goods
Production Cost Savings:
- Use of Risk Management to drive cost savings
- Lean, Six Sigma and Kaizen Events
Logistics Operations
- Warehousing and storage processes
- Product receipt and distribution processes
- Packaging, labeling and product preservation
- Transit studies and validation of transportation methods
- Product Tracking and Distribution records
Servicing processes and product acceptance after servicing
- Field Service Product Maintenance
- Emergency Service Calls with linkage to Customer Complaints

Supplier evaluation and selection
Supplier Audits and Supplier Qualification with linkage to Risk Management
Supplier Agreements
Roles and responsibilities between the Registered Manufacturer and suppliers, CDMO, CMO, Distributors, etc.
Maintaining the Approved Supplier List (ASL) and ensuring its use in Purchasing
Approved, preferred, and conditional suppliers
Supplier approval and material / component approval
Supplier performance monitoring and metrics
Oversight of OEMs, CMOs, Distributors, Authorized Rep, etc.
Required Purchasing documentation
Required receiving and inspection documentation
Supplier Files

Change Control

Design Changes during the Design and Development process
Product changes or enhancements after product launch
Production process or test method changes
Facilities or equipment changes
Supplier changes
Changes made by suppliers
Deviations or temporary changes
Evaluation of cumulative change and Regulatory submissions
The role of Risk Management in Change Control
Roles and responsibilities of individuals and functions during Change Control

Post-Market Activities

Measurement, Analysis and Improvement
Corrective and Preventive Action (CAPA)
- CAPA process, governance, timing and metrics
- CAPA backlog remediation
- CAPA Owner and CAPA Review Board Training
Customer Feedback, Complaint Management and Reporting
- Complaint intake and investigation process
- Remediation of complaint backlog
- Use of Risk Management and IMDRF codes for adverse event reporting
Field Safety Corrective Actions
Reports of Corrections and Removals
Product Tracking and Recall
Complaint Trending
Post-Market Surveillance
- Linkage of Post-Market Surveillance to Risk Management and Post-Market Clinical Follow-up

Management Responsibility

Management Responsibility processes including appointment of a Management Representative and a Management Rep Deputy
Training of Management and provision of advisory services
Management Review process optimization
Identification of appropriate QMS metrics and key performance indicators (KPI)
Internal audit programs including scheduling, auditor qualification, execution, audit records and closure
Performance of audits and assessments
Continuous Process Improvement ensuring the QMS is effective, efficient, and sustainable
QMS alignment with global regulatory requirements where products are marketed, specializing in USA, Canada, European Union, United Kingdom, Japan, Brazil, Australia and other ROW requirements as needed

Specializing in Medical Devices, In-Vitro Diagnostics and Combination Products

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