Supplier will perform a large part of the validation work for an automation system. It is important that supplier and regulated company can trust each other on that. For that reason long term relationship must be built between supplier and regulated company. Of cause the regulated company keeps the responsibility for the validation, but with the proper precautions and good quality documentation from suppliers can be leveraged.
An instrument to build the trust in the relationship is to perform supplier assessments.
Supplier assessments can be postal questionnaires or formal assessments at the supplier’s premises.
Postal questionnaires are used when suppliers must be selected. A questionnaire is sent to the supplier to get information about:
- Company details
- Experience with relevant systems, applications and industries
- Project team members
- The actual quality system
When a postal assessment is successful and the supplier is a real candidate for the project, a formal assessment at the supplier’s premises takes place. The assessment is done by Subjects Matter Experts and Quality Officers of he regulated company. Subjects for inspection with documented evidence are:
- The quality system
- Employee training records
- A skills or capability matrix of the employees
- The organizational structure of the company
- Good Engineering Practices (GEP) procedures in use
- Available environment and equipment for the project
- Examples of similar projects
Important is the contact with potential team members during the assessment. Reference visits may also be required to get a feeling about the supplier’s quality.
When starting a relationship with a new supplier always start with small project. This will allow you the get to know each other. When there is no fit between the companies the relation can be terminated with large negative effects. Another option to get to know each other is to start a prototype phase before starting the main project.
Supplier quality system
The supplier documented quality system must describe Good Engineering practices and Good Documentation practices. In addition to the quality system a Project and Quality Plan must be written for project specific items. This will reduce a lot of noise in the communication during the project. All project members must be aware of that plan and must live according the plan.
The project will run smooth with supplier with a formal quality culture and has the core business in the Life Science industry. That care must be given to suppliers that work occasionally in the Life Science industry.
Supplier guidance is important throughout the project. Intensive contact during the project is essential. With longer running relationships the guidance may be less intensive, but may never be minimized. Intensive guidance wil reduce the total duration of the project and reduce the total cost.
Good Engineering Practice Procedures and Good Documentation Practices must be monitored throughout the project duration, as well as technical aspects and risk management.
More details about supplier assessments can be found in:
- Gamp 5
- ASTM 2500-7
- ISPE Good Practice Guide Good Engineering Practices
- ICH Q9