Competences

100 % quality, one result: Long-term cooperation.

At FAMAC® it is a standard procedure to approach every development systematically. Our certified quality management system offers you safety in every respect. This way, a cooperative partnership becomes a mutual, long-term success.

You can count on us to meet agreed quality targets.

Implementation of a quality management pursuant to ISO 13485:2016. Pöppelmann FAMAC® also carries out an inspection using 3D coordinates as well as multi-sensor measurement technology. Our quality assurance also includes the identification of opening and extraction forces and special tests for certification by an independent institute.

Implementation of a quality management system.

Implementation of a quality management system.

Inspection of agreed features during production.

Inspection of agreed features during production.

Optical and tactile measurement.

Optical and tactile measurement.

Special tests: Certification of childproof closures by an independent institute.

Special tests: Certification of childproof closures by an independent institute.

Identification of opening and extraction forces.

Identification of opening and extraction forces.

<p><span style="color:#084686"><strong><span class="margintop10">Implementation of a quality management system.</span></strong></span></p>
<p><span class="margintop10"><strong><span style="color:#084686">Inspection of agreed features</span></strong> during production.</span></p>
<p><strong><span style="color:#084686"><span class="margintop10">Optical and tactile measurement.</span></span></strong></p>
<p><span class="margintop10"><strong><span style="color:#084686">Special tests:</span></strong> Certification of childproof closures by an independent institute.</span></p>
<p><span class="margintop10">Identification of <strong><span style="color:#084686">opening and extraction forces.</span></strong></span></p>

Certified safety in every respect:

BRC Global Standard

For packaging and packaging materials (Issue 5, High Hygiene)

ISO 13485

Quality management system for the design and manufacture of medical devices

ISO 50001

Systematic
energy management

SEDEX Ethik Standards

Transparency in social and ethical processes within the framework of the supply chain

The advantages of our quality management at a glance:

  • Efficient. Materials undergo goods receiving inspection using thermal analysis (DSC).
  • Economical. Tactile and optical measurement using 3D measuring technology.
  • Flexible. Three-dimensional measurement using GOM.
  • Documented. In-process monitoring.
  • Certified. BRC Global Standard, ISO 13485:2016, DIN EN ISO 50001:2011, SEDEX Ethik Standards.

From development to serial production: the continuous quality management system.

The highest demands on technology and quality are met from the very beginning of component development right up to the release of the implemented and final mould. In four steps, all industrialised stages of the manufacturing process are examined, documented and qualified. The demands on the component are laid down in the specification document and implemented using the appropriate mould concept.

This step checks if the mould was produced in accordance with DQ requirements, once it's completed. Inspection plans are simultaneously coordinated with the costumer (Installation Qualification).

This phase serves to determine a safe process window. "DOE tests" ("Design of Experiments") are used to determine and document process parameters and their impact on the component. As part of this "Operational Qualification", both the performance and machine capabilities of the mould are examined.

This qualification step makes the process and the parameters of its influence as well-known as possible. The process capability of the component is determined and assessed. Once the PQ (Performance Qualification) completes, a go-ahead is given for serial production.

Qualitaetssicherung
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Contact

Do you have any questions? The FAMAC® team will be happy to answer them.

On-site

Our sales representatives can come straight to your premises. Make an appointment now.

+49 4442 982-3900

Monday through Thursday: 8:00 – 17:00 p.m.
Friday: 8:00 – 15:30 p.m.

By e-mail

Twenty-four hours a day. We will get back to you as soon as possible.

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