19 Nov Vaccine Manufacturer
Batch Record Redesign & Simplification
Client Situation
- High percentage of Batch Record errors and missing entries contributing to extended Product Release times.
- Extended manufacturing and product release cycle times negatively impacting supply chain and profitability.
- Client attempted internal effort for over 9 months with limited success, needed direction and guidance.
- Needed a redesigned Batch Record to prepare for migration to Electronic Batch Record.
Key Issues and Internal Barriers
- Past efforts to streamline and simplify Batch Records have not produced the expected and necessary results.
- Resource, workload, time constraints, and priorities of other initiatives.
- Lack of methodology and inability to get agreement between QA and manufacturing on what constituted ‘good documentation practices’.
- Difficulty training new personnel quickly on documentation.
Client Strategic Objectives
- Improve content, clarify work instructions, reduce Batch Record errors, make the documents user friendly, increase ‘right first time’ quality, and reduce Batch Record review and Product Release cycle times.
- Develop and implement consistent documentation rules and industry best practices.
Key Program Components
- Develop Guidance document to define documentation rules, best practices, and eliminate barriers between QA and manufacturing.
- Redesign a Batch Record that ‘fits’ the actual process.
- Reduce procedural errors and potential for errors.
- Eliminate redundant and unnecessary data requirements, and forms.
- Reduce Batch Record review and Product Release cycle times.
- Reduce deviations and investigations.
- Improve and reduce time to train new personnel.
Results and Improvements
- Developed guidance and facilitated QA and manufacturing agreement to establish rules and consistent documentation practices across operations.
- Reduced number of Batch Record pages by 15% and eliminated 40% of the redundant supplemental forms.
- Reduced 22% of the data entries even after adding 10% additional data entries to address compliance issues.
- Error rates and review cycle times reduced.
- Eliminated redundant information, included clear, consistent identification of specifications to meet process requirements.
As a result of Malcom’s redesign initiative, the client expanded the new redesign and guidelines to the remaining business units and products.
Primary measurable results:
