QUALITY SYSTEM
FORGINAL medical
+33 473 80 30 89
QSE@forginal.com
“FORGINAL medical has always treated quality as a priority; we are aiming at a market which demands high quality parts, delivered in perfect condition. In that context, the role played by the quality assurance staff is fundamental. Our forged parts are highly technical and there is always something new to learn.”
OUR COMMITMENT TO QUALITY
FORGINAL medical is a pioneer in the medical device subcontracting market, and was one of the first orthopaedic implant manufacturers in France to achieve ISO 13485 certification for medical implants. We have been totally focussed for more than 30 years on achieving zero defects and an impeccable quality of finish for your forged implants.
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Our quality system
Quality, safety and environment policy
FORGINAL medical‘s strategy is set out in a 5-year improvement plan. Each year, the quality policy defines the main areas of work in line with the improvement plan. This policy systematically contains a quality aspect, a safety aspect and an environmental aspect. Progress in relation to the quality policy and the improvement plan is reviewed twice a year by the management.
Quality
PROCESS/TRACEABILITY/TESTS
Quality is ensured throughout the production process in particular by means of a tracking sheet, appropriate batch packaging and permanent labelling.
The tracking sheet follows the production batch, starting with the tooling itself. It details the production stages, the associated parameters and the applicable documents. All the tests carried out during production are recorded on this sheet. It will be kept for 35 years, with all the records for the batch to which it refers.
Each year a team of internal auditors carries out a full audit of the quality system. Actions resulting from previous audits are systematically reviewed and signed off. As well as system audits, environmental and product audits are carried to ensure that the company’s processes are fully effective, in particular with regard to the following points :
- Qualification of staff
- Qualification of production machines
- Continuous improvement system:
- All staff are encouraged to submit suggestions for improvement. Any non-conformity or risk forms the subject of a non-conformity report. These reports are dealt with in working groups.
- We capitalise on all this information, enabling us to remain aware of the main points for attention on our various parts and tools.
- SPC (statistical process control)
FORGINAL medical is ISO 13485 certified for drop forging parts for the medical market. Third-party audits are carried out annually. These audits are used as sources for improvement within the company. Numerous improvements have resulted from such audits. Robustness tests are carried out on our quality system (documentation system, customer and normative requirements, traceability, quality assurance plan, records, staff accreditation, etc.) to ensure continuous improvement.
FORGINAL medical works completely transparently with its customers and is always happy to welcome them for visits or audits. Every year, ten or so customers come and audit us, which helps identify new ways of improving.
FORGINAL medical has a list of subcontractors approved according to precise quality criteria. Depending on the criticality of the supplier, documentation or on-site audits are organised periodically, with an assessment twice a year in order to maintain the supplier’s qualification. If there is any deterioration in quality or logistics, action plans are called for and specific monitoring implemented, or a supplier may even be disqualified.
Safety
Labour policy: improvement of working conditions
FORGINAL medical invests every year to improve working conditions. Psychological and social risks are taken into account as well as the risks of FORGINAL medical‘s staff developing musculo-skeletal disorders. The management of FORGINAL medical always listens to its staff, and undertakes each year to reduce overall the risks to which its teams are exposed.
Staff training is a priority in order to increase the loyalty of the teams and enhance their skills. All newcomers have a period of mentoring. They learn about their duties and any associated risks accompanied by a person who is experienced in the job.
A quarter of the company’s workforce is qualified as workplace first-aiders. The safety policy is based on their feedback and that of the company’s committee for health and safety at work.
Environment
Preparation for iso 14001 certification
FORGINAL medical has started the process for iso 14001 certification in the medium term. environmental protection measures have already been put in place :
- Discharge of penetrant inspection products blocked by an active carbon water treatment system
- Waste water continuously monitored, with recording of the results and more in-depth annual tests
- Sorting of waste (wood, stainless steel, titanium, etc.)
- We have made the environmental choice to work with cardboard boxes and pallets only
- We have rationalised the dimensions of our packages to make them as small as possible
- FORGINAL medical has a settling tank for treating rainwater
All our purchased products comply with REACH requirements. We require our suppliers to comply fully with these requirements, and we check them periodically.