Fai­lure avoi­dance and cost re­duc­tion through ef­fi­cient CAPA ma­na­ge­ment

When ex­por­ting me­dical tech­no­logy pro­ducts to the USA, the re­qui­re­ments of the FDA (Food & Drug Ami­nis­tra­tion) must be met. One of their re­qui­re­ments is the use of an ef­fec­tive Cor­rec­tive Ac­tion / Pre­ven­tive Ac­tion system (CAPA).

Ap­pro­xi­ma­tely 30% of the con­tes­te­d ­dis­crepen­cies re­sul­ting from FDA in­spec­tions can be at­tri­buted to ­poor im­ple­men­ta­tion of CAPA sys­tems, or to the ab­sence of such sys­tems.

Risk ma­na­ge­ment is an in­dis­pensable part of en­tre­pre­neu­rial ma­na­ge­ment in any busi­ness.

Use the sys­te­matic FMEA ap­proach to ana­lyze sys­tems and risks in order to avoid need­less costs and lia­bi­li­ties.

Pro­ject Ma­na­ge­ment in com­pliance with APQP as an ac­tive ele­ment across all phases of the pro­duct life cycle.

Learn about the be­ne­fits that the use of APQP (Ad­vanced Pro­duct Qua­lity Plan­ning) will bring to your pro­duct de­ve­lop­ment and plan­ning pro­cesses.

View Com­plaints as an op­por­tu­nity and use them as such.

To­gether with you we would like to ex­plore the broader is­sues of the often un­plea­sant topic of com­plaints

Pro­perly ma­nage the com­plaints pro­cess and the costs as­so­ciated with gua­ran­ties and war­ran­ties.