Vladimir Seredyuk, QA Director, conducted an internal training related to recent updates of GCT SOPs, which come into effect July 2017.
GCT Quality Assurance (QA) system comprises internal standard operating procedures (SOPs) and working instructions which are continuously monitored, maintained and improved. The Quality in our procedures and services provided is ensured by:
- The strict implementation of our Standard Operating Procedures (SOPs);
- Continuous training of personnel including assessment and compliance controls;
- Internal audits at regular intervals and audits conducted from our clients;
- Implementation of a CAPA system with root cause analysis and close follow up as a way towards improvement and effectiveness of the Quality assurance system.
Standard Operating Procedures (SOPs) are documented for all tasks.
When are SOPs updated?
QA Director or QA Manager initiates the review current SOPs every 2 years based on the anniversary of the date issued. CEO and General Director approves SOPs or requests corrections and provides respective comments to the QA Director or to the designated person.
How is the staff made aware of SOPs and publications?
After each update QA team sends out the effective version of SOPs to all GCT employees by e-mail with copies stored at GCT servers.
Is there any special SOP training in place?
The SOPs training is performed for:
- New employees according to the individualized training plan;
- Previously trained personnel in case of SOP update with significant changes or new SOP development.
The SOP training for SOP authors and reviewers is not mandatory.
Are your SOPs written in English?
GCT corporate language is English. Therefore, all documents, including SOPs are in English.
Are SOPs global or country-specific?
SOPs are global and country-specific.
Do you have a procedure describing the process of management of quality documents?
There is a special procedure of managing SOPs and a special SOP, describing it.
To document SOP deviation there is SOP «SOPs Preparation, Issue and Revision» which regulates this process, each SOP deviation is documented using Standard Forms «SOP Deviation Form» and «SOP Deviation Log».
Do you have a system to control and track SOPs (i.e. numbering, management approvals, distribution, effective dates, archival of older versions, etc.)?
LMS is used to control and track SOPs.
Do you have a Vendor Management SOP?
GCT suppliers and subcontractors are also assessed and approved based on the special SOP «Vendor Selection and Audit».
GCT team is ready to provide copies of applicable SOPs related to quality system upon special request.