{"id":151,"date":"2013-10-28T04:15:53","date_gmt":"2013-10-28T04:15:53","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=151"},"modified":"2013-10-28T04:15:53","modified_gmt":"2013-10-28T04:15:53","slug":"iso-9001-iso-13485-clause-6-1-iso-22716-cosmetics-gmp-clause-3-provision-of-resources","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=151","title":{"rendered":"ISO 9001 \/ ISO 13485 clause 6.1 | ISO 22716 Cosmetics GMP clause 3 – Provision of Resources"},"content":{"rendered":"

Organizations shall determine and provide resources needed:<\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0 to implement the quality management system and to maintain its effectiveness<\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0 to meet regulatory and customer needs<\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0 relevant for its size and the diversity of products<\/span><\/p>\n

A good measure of how an organization can meet customer demand is to measure TAKT time. <\/span><\/p>\n

\u201cTakt\u201d is the German word for the baton that an orchestra conductor uses to regulate the speed, beat or timing at which musicians play. So TAKT Time is \u201cBeat Time\u201d, \u201cRate Time\u201d or \u201cHeart Beat\u201d. Lean Six Sigma uses TAKT Time as the rate that a completed product needs to be finished in order to meet customer demand. <\/span><\/p>\n

Calculating TAKT Time:<\/span><\/strong><\/p>\n

TAKT Time = customer demand \/ available time.<\/span><\/p>\n

Eg if a TAKT time of 2 minutes is calculated, this implies that an organization requires to complete a product every two minutes.<\/span><\/p>\n

The next step is to compare your cycle time against TAKT time for each process involved (normally by Bar Chart). If each cycle has a TAKT time of <2 minutes then your organization is capable of meeting customer demand. If TAKT time for a process is >2 minutes then this process is considered a bottleneck and requires review in order to improve efficiencies so that customer demand can be met.<\/span><\/p>\n

Another method in determining whether customer demaind is met is calculating DIFOT (Delivery In Full On Time. Internal KPI\u2019s (eg 95% DIFOT) can be set and reviewed monthly.<\/span><\/p>\n

About CMS:<\/strong><\/span><\/p>\n

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS\/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Organizations shall determine and provide resources needed: \u00b7\u00a0\u00a0\u00a0 to implement the quality management system and to maintain its effectiveness \u00b7\u00a0\u00a0\u00a0 to meet regulatory and customer needs \u00b7\u00a0\u00a0\u00a0 relevant for its size and the diversity of products A good measure of how an organization can meet customer demand is to measure TAKT time. \u201cTakt\u201d is the German word for the baton that an orchestra conductor uses to regulate the speed, beat or timing at which musicians play. So TAKT Time is \u201cBeat Time\u201d, \u201cRate Time\u201d or \u201cHeart Beat\u201d. Lean Six Sigma uses TAKT Time as the rate that a completed product needs to be finished in order to meet customer demand.[…]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-151","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/151","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=151"}],"version-history":[{"count":1,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/151\/revisions"}],"predecessor-version":[{"id":152,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/151\/revisions\/152"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=151"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=151"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}