Organization and Quality systems Approximately how many employees do you have? Site total …………………….. R&D …………………….. QA/QC …………………….. Production …………………….. Does the company have a policy on HSE (Health, Safety, Yes No N/A □ □ □ & Environment)? Do you have a Quality Management (QM) System in Yes No N/A □ □ □ place? Is the QM or HSE system certified? Yes No N/A □ □ □ Please specify the type of certificate; ISO 900x/ GMP/ Other ………………. Certificate expiry date: ……………….. ISO1400x/ Other ………………. Certificate expiry date: ……………….. Do you have an independent QA/QC department? Yes No N/A □ □ □ Do you have a change control system? Yes No N/A □ □ □ Is there a procedure to notify customers of change? Yes No N/A □ □ □ Do you have procedure on how to handle customer Yes No N/A □ □ □ complaints? Do you have a deviation system or a corrective and Yes No N/A □ □ □ preventative action (CAPA) programme? Do you have approved manufacturing instructions? (e.g. Yes No N/A □ □ □ batch records) Do you have documented procedures for equipment and Yes No N/A □ □ □ facility cleaning? Do you have an employee training programme? Yes No N/A □ □ □ Analytical Capability
Organization and Quality systems Approximately how many employees do you have? Site total …………………….. R&D …………………….. QA/QC …………………….. Production …………………….. Does the company have a policy on HSE (Health, Safety, & Environment)? Yes □ No □ N/A □ Do you have a Quality Management (QM) System in place? Yes □ No □ N/A □ Is the QM or HSE system certified? Please specify the type of certificate; ISO 900x/ GMP/ Other ………………. ISO1400x/ Other ………………. Yes □ No □ N/A □ Certificate expiry date: ……………….. Certificate expiry date: ……………….. Do you have an independent QA/QC department? Yes □ No □ N/A □ Do you have a change control system? Yes □ No □ N/A □ Is there a procedure to notify customers of change? Yes □ No □ N/A □ Do you have procedure on how to handle customer complaints? Yes □ No □ N/A □ Do you have a deviation system or a corrective and preventative action (CAPA) programme? Yes □ No □ N/A □ Do you have approved manufacturing instructions? (e.g. batch records) Yes □ No □ N/A □ Do you have documented procedures for equipment and facility cleaning? Yes □ No □ N/A □ Do you have an employee training programme? Yes □ No □ N/A □ Analytical Capability
Supplier%20Qualification%20Questionnaire.docx