14 - Document Control and Retention
Detailed consideration should be given at the very outset so that all pertinent records can be retrieved when needed. The availability of necessary documentation (design drawings, meeting notes, written contracts, e-mail and other electronic media) can help identify and locate the products that might reach customers in a defective condition. Documentation control also includes a system for identifying and classifying criticality of documents, protection of the documents, and length of retainment. Effective documentation can be useful in demonstrating to the courts and hires the extreme care the company take to design, manufacture and sell safe products.
What do we look for?
- Complex documents relating to legal compliance or quality testing required
- Long product life cycle
- Products with high reuse / resale potential
- Product supply chain is complex with high need for upstream / downstream traceability
- High geographical spread and potential exposure to mass litigation.
- All product liability relevant documents are retained, including design drawings, prototypes, meeting minutes, written contracts, including change orders, purchase requisitions
- A formal system for identifying and coding the criticality of documents
- Documents are secured from perils (i.e. fires etc) and computer failure.
Risk improvement ideas
- All documents, including hardcopy and electronic are properly protected against all perils such as fire
- All documents are backed up and kept off site.