Category Archives: Quality Systems And Compliance

SOLUTION YIELD ACCOUNTABILITY IMPROVEMENTS

A pharmaceutical manufacturer contacted Dellshire to improve their raw material yield and accountability practices. The company reported an unacceptable variation in yield calculation which had resulted in CAPA’s and nonconformances which were open for an unacceptably long period of time.

The Dellshire business process improvement SMEs leveraged LEAN/Six Sigma methodologies and multiple tools throughout the project execution. Work sessions with a cross functional team were conducted to methodically investigate the contributing factors which resulting in significant learning related to causes for the current performance.

Issues relating to process equipment variation, data entry documentation and calculation errors, and inadequate specifications were identified and characterized at a detailed level. An action plan was created and implemented which included the development of a new yield worksheet with improved, simplified, calculations. Process capability studies provided additional control and benefits and also were used to establish the acceptance limits for yield calculations and reestablished process limits.

The company piloted the changes and later reported greater yield of raw material; reducing costs significantly and also superior compliance as accountability methods and accuracy were improved.

DESIGN HISTORY FILE REMEDIATION

Completion of a program to implement product design improvements prompted a major medical device manufacturer to update their DHF which did not keep pace with regulation or previous product changes. Dellshire SMEs worked with the management and technical teams to devise a product portfolio plan that would leverage required remediation work pertaining to Design Inputs. Products were then prioritized based on schedule and business impact, and work was initiated. On occasion, it was found that some requirements were needed that were not defined or understood. Dellshire led the effort to produce test samples, define and qualify inspection methods, and generate the data necessary to understand legacy product performance and define the Design Inputs.  This template was applied to all products in the product family, and once complete, the company was able to move forward and complete design verification on the improved product designs.

FDA 483 REMEDIATION: VERIFICATION AND VALIDATION

A medical device manufacturer received a FDA 483 concerning their procedures and practices regarding design verification and validation. Dellshire experts completed a deep dive to fully understand the breadth and scope of the issues and provided a comprehensive plan to address the company’s needs. Procedures for Design Controls were remediated as well as procedures for other key aspects of their business including Risk Management, CAPA, Complaint Management, and Document Control. Once all procedures were approved and implemented, training was conducted and a retrospective review and qualification of design changes was completed in accordance with these procedures. Completion of these tasks and providing this service allowed the company to address the concerns of FDA, improve the integrity of their quality system and reinforce the quality of their products in the market.

ROOT CAUSE ANALYSIS AND IMPLEMENTATION

Product complaints were being received by a medical device manufacturer and resolution of a design issue was needed to address product quality and safety issues. Dellshire engineers recommended that a root cause analysis be completed using a structured problem solving approach. After a clear and accurate problem statement was created and agreed upon, root cause analysis tools were deployed including Is-Is Not, Fault Tree Analysis, Fishbone Diagram and Contradiction Matrix to quickly identify probable root cause. A test machine was designed and built and was used to evaluate design options. The business was able to evaluate the implementation plans for the viable options and determine the appropriate course of action based on the work that Dellshire completed.

CAPA/ PROBLEM SOLVING

Focused multi-team effort was oriented around several CAPA projects.  Effectively completed root cause analyses, validation, design transfer and implementation. Structured problem solving approach was customized for medical device client and deployed to resolve open CAPAs; implementation process architected for rapid deployment and risk management of product design and manufacturing process changes.  Training program created and deployed throughout operations, quality and engineering organizations.

DESIGN CONTROL/DESIGN VERIFICATION

A major medical device manufacturer requested a recommendation for improving its ability to select statistically valid sampling plans for Design Verification activity supporting its new product in development.  An assessment determined several opportunities for improvement including clearly delineated design verification requirements; identification of risk classification; leverage of legacy acceptance criteria; new acceptance criteria with statistical rationale.  The output of this database was valuable in planning and writing the appropriate design verification protocols.

QUALITY SYSTEM DESIGN AND IMPLEMENTATION

An industrial supplier of metal components was entertaining a pharmaceutical client in need of components for a drug delivery device and was in need of a quality management system to meet the requirements of this customer.  Dellshire consultants authored and deployed a complete quality management system, customized and “right-sized” for their business scale and processes.  The supplier then was able to secure this new business and develop a new business segment for medical products.

VALIDATION PLANNING AND EXECUTION

Multiple validation projects were completed.  Tasks and deliverables included facility inventory and reviews of existing manufacturing, testing and support processes; validation needs assessments completed as input to the Master Validation Plan authored by our consultants; deployment and training of validation plan and procedures.