Quality Assurance and Control organizations face a multitude of demands, including reduced cycle-time, increased efficiency, improved right-first-time levels, and better schedule adherence. They are always under pressure to control cost, quality, reliability and speed, whilst always complying with regulatory requirements.
Through a holistic approach that includes people, procedures, processes and systems, we help to produce a quality culture that can overcome all the above demands.
Dahlia Consulting has extensive experience around the globe in quality improvement projects, and holds vast knowledge of QA & QC operations in the life-sciences and manufacturing sectors, including:
- Productivity Improvement; we help QA and QC operations to reduce the cost of operation through streamlining processes, improving flow and increasing operational speed, ultimately delivering the same output with less required resource.
- Evaluating and stream-lining written procedures and standard operating procedures
- Helping to interpret regulations in concert with industry standards
- Developing laboratory quality, analytical methods, methods validations, and product component specifications
- Creating a program to meet current FDA expectations for GLP Compliance
- Lab resource planning and scheduling; support labs by implementing planning processes with innovative planning & scheduling tools to optimize lab operations and service levels.
- Performing trend analysis
- Providing corporate oversight programs and enhancement — including good governance practices; corporate quality/compliance functions and oversight practices; and independent advice to CEOs, senior managers, and board members
- Implementing site oversight programs, including internal audits and performance metrics
- Reviewing and enhancing management controls
- Reviewing and enhancing organizational structures — including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality units
- Delivery reliability improvement we support our clients to identify root causes for not meeting service levels, and lead them through the implementation process for cycle time reduction and service level enhancement.