Effective communication, organization, documentation, and education of business processes for timely project completion.
Communication
Compile a database of the available project information by communicating with management, stakeholders, and other subject matter experts.
Organization
The database is analyzed, reviewed, filtered, categorized, and synchronized to match requirements.
Results
- Obsolete information removed
- Missing data identified
- Task list clarified
- Secure, reliable, scalable database
Documentation
- Business process documentation and training guidelines
- Database support
- Compliance with applicable regulations
Results
- Business process overview
- Roles and responsibilities
- Organizational structure
- Version control and tracking system
- Training curriculum
Documentation Management
The system should include:
- Format
- Terminology
- Preparation
- Review
- Approval
- Issuance
- Implementation
- Distribution
- Revision
- Archiving
- Security
Categories
For example:
- Corporate Policies
- Operational Procedures
- Work Instructions
- Organization Charts
- Forms
- Templates
- Agreements
Education
ISO 13485
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills, and experience. The organization shall document the processes for establishing competence, providing needed training, and ensuring awareness of personnel.
The organization shall:
- determine the necessary competence for personnel performing work affecting product quality;
- provide training or take other actions to achieve or maintain the necessary competence;
- evaluate the effectiveness of the actions taken;
- ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;
- maintain appropriate records of education, training, skills, and experience.