Strand of Silk Interview Questions and Answers

Inprocess check failure of metal detector can be handled by following proper procedures and protocols.

• Immediately stop the production line and isolate the affected product.

• Investigate the cause of the failure and take corrective actions.

• Notify the quality control department and involve them in the investigation.

• Conduct a thorough inspection of the metal detector and ensure it is functioning properly before resuming production.

• Implement preventive measures to avoid similar inc...read more

Improving productivity in manufacturing involves optimizing processes, reducing waste, and investing in technology.

• Analyze current processes and identify areas for improvement

• Implement lean manufacturing principles to reduce waste and increase efficiency

• Invest in automation and technology to streamline production

• Provide training and development opportunities for employees to improve skills and knowledge

• Establish clear goals and metrics to track progress and identify areas for...read more

Factors affecting weight variation during compression include formulation, equipment, and process parameters.

• Formulation: particle size, shape, and density, excipient type and concentration

• Equipment: type of tablet press, tooling, and compression force

• Process parameters: compression speed, dwell time, and pre-compression force

• Example: changing the excipient concentration can affect the weight variation of tablets

• Example: using a different type of tooling can affect the weight...read more

Handling unionized manpower requires effective communication, negotiation, and collaboration.

• Establish open communication channels with union representatives

• Negotiate fair and reasonable terms for both parties

• Collaborate with union leaders to address any issues or concerns

• Ensure compliance with labor laws and regulations

• Provide opportunities for employee feedback and involvement

• Maintain a positive and respectful work environment

• Resolve conflicts in a timely and professional m...read more

21 CFR part 11 is a regulation by the FDA that defines the criteria for electronic records and signatures.

• 21 CFR part 11 applies to pharmaceutical, biotech, and medical device companies.

• It requires electronic records to be trustworthy, reliable, and secure.

• It also requires electronic signatures to be legally binding and equivalent to handwritten signatures.

• Examples of electronic records include clinical trial data, manufacturing records, and quality control data.

• Examples of e...read more

OEE stands for Overall Equipment Effectiveness and is a measure of how effectively equipment is being utilized.

• OEE takes into account three factors: availability, performance, and quality.

• Availability refers to the amount of time the equipment is available for use.

• Performance refers to how efficiently the equipment is running.

• Quality refers to the number of good units produced by the equipment.

• OEE is calculated by multiplying availability, performance, and quality percentages...read more

Operational excellence is the continuous improvement of processes and systems to achieve maximum efficiency and effectiveness.

• It involves identifying and eliminating waste and inefficiencies in processes

• It focuses on improving quality, reducing costs, and increasing productivity

• It requires a culture of continuous improvement and employee engagement

• Examples include Lean Six Sigma, Total Quality Management, and Kaizen

• Operational excellence can lead to increased customer satisfa...read more