JOURNAL OF AN AUDITOR

  IATF GLOBAL WAIVERS and MEASURES IN RESPONSE TO THE CORONAVIRUS PANDEMIC (COVID-19)   Revision 1 (9 April 2020) In the first revision, the standard of IATF 16949, in the ‘‘Nonconformity Management’’ changed from 60 calendar days to a maximum of 90 days. In this new revision, they explain the original timings and additional maximum allowances in one graphic. In addition to this, timing requirements changed to a certification decision, they permit more time and flexibility. Revision 2 (27 April 2020) The second revision is about ‘‘IATF 16949 Monitoring’’. With Covid-19 ‘‘3rd Party Audits’’ and ‘‘Nonconformity Management’’ affected dramatically., IATF 16949 defined a new process for the Certification body. According to IATF Requirements, CB assesses, audit, monitor the organizations in order to be continued effectiveness of the client’s Quality Management System remotely. Revision 3 (8 June 2020) In this third revision, there are some updates. -      ...

  MEDICAL DEVICE REGULATION EUROPE What is the difference between Regulation and Directive? What permission is required to get your medical device to be sold in Europe?   There are quite differences between regulation and directive. Firstly, a competent authority has 28 member states in the EU and each one of this member states have it’s own competent authority ,therefore, to publish and to direct are in their responsibility. The rules come from the European Commission as a pioneer. Notified body audit manufacturers to ensure compliance with European Union rules. Secondly, there are 3 directives that are rule. The organizations need to follow this 3 directives in order to manufacture a medical device, to get permission and also to set up the medical device in Europe; a) Active Implantable Medical Device Directive, b) The Medical Device Directive, c) The Directive of in Vitro Diagnostic Medical Devices. Then, in medical devices, categorization is also s...

 TO GET ISO 9001 CERTIFIED:   All of these are reasons to have ISO 9001 certified. My company has ISO 9001 certified because this was the first customer requirement. If the organization cannot prove its QMS, you cannot have a chance to work with them. Also, Implementing ISO 9001 will improve your company's reputation. To market, the company's compliance to ISO 9001 internationally is a must! Having a System always brings quality. When the company products, they should comply with contractual obligations and expectations. Having a system or having ISO 9001 certified will provide a competitive advantage.  On the other hand, ISO 9001 is just a guide on how to build QMS. Here the most essential thing is each department to work integrated. Working integratedly and consciously provides continuity, efficiency, and continuous improvement and helps us measure the effectiveness of the System.  There are many advantages to have ISO 9001 certified. Some of them are: ...

  DOES IMPLEMENTING ISO 9001 HAVE ANY EFFECTS ON ONE'S COMPANY CULTURE? Corporate culture is the norms, beliefs, attitudes that direct the behavior of people working in an institution. E.g.; quality/occupational objectives, quality/occupational policies, organizational structures, company purposes, mission visions leadership experiences and their knowledge, strategic thinking, ethical norms, to increase customer satisfaction, etc.   Changing culture always doesn’t need implementing QMS such as ISO 9001. The organization can change a culture without standardization. Changing culture is not easy for some companies. To ready/open for change depends on current situations and top managers.   Adapting culture should start from the top management and these adapting process should continue to the lowest level employees.   Innovation and change are necessary for a culture to form. This leads to a change in behavior. Change takes place step by step. Achieving and maint...

 THE REQUIREMENTS OF IATF 16949 CLAUSE 7.2.3 According to the IATF 16949 Clause 7.2.3 (Internal auditor competency), there are not any requirements to have internal auditors such as a lead auditor in automotive industries.  In my experience, External auditors are not logical to make the internal process and product audits. Sometimes the organization can want to check itself from external auditors to take objective thoughts. It can help because sometimes internal auditors can be blind or can't see to catch the unconformities.  Also, the organization can receive training from the external auditors. To give motivation and information for the employees, taking training from outside can be effective to increase auditor qualifications.    However, the organization should define an internal audit procedure, checklists, and internal auditors. Every time the organization cannot take supports from the external auditors so every department owner should be able to check the...

  HOW WE CAN RESTART OPERATIONS AFTER A LOCKDOWN ON MANUFACTURING PLANT ACCORDING TO IATF 16949:2016?   IATF 16949: 2016, 8.5.1.4 Verification after shutdown  "The organization shall define and implement the necessary actions to ensure product compliance with requirements after a planned or unplanned production shutdown period"         For a long time, all around the world had to stopped in especially the automotive industry because of the Covid-19. These days, the automotive industry will start to manufacture. That's why I would like to point out in the automotive industry about the standard of the IATF 16949:2016, 8.5.1.4 Item: The Verification After Shutdown due to Covid-19.         First of all, before manufacturing, we have to connect with our customers and we have to take some important pieces of information. Some of them are; When will they start production on their plant? How much your...

PROCESS FAILURE MODE and EFFECTS ANALYSIS AIAG&VDA FMEA HANDBOOK-June 2019-1.Version FMEA handbook is used by the automotive sectors. FMEA studies should have complied when the customer’s requirements. FMEA is divided into 2 types. These are Design FMEA and Process FMEA. The cause of the FMEA’s Handbook publishing: 1.OEM expects high quality, 2.The cost optimization on the processes and the products, 3. The types of different process arise due to high part’s production, 4. The production requirements are with local/legal regulations. The FMEA method can be studied in systematic perspectives, group studies, analytic approaches, and qualitative and quantitative approaches. The goal of FMEA’s studies are; 1. To assess the potential risks in terms of the technical at the products and processes, 2. To analyze the effects and causes of the errors can be occurred from the potential risks, 3. To find and prevent the errors, activities should be documented...

PROSES HATA TÜRÜ ve ETKİLERİ ANALİZİ/PROCESS FAILURE MODE and EFFECTS ANALYSIS AIAG&VDA FMEA HANDBOOK-June 2019-1.Version FMEA çalışmaları otomotiv sektöründe kullanılır. FMEA çalışmaları müşteri özel şartlarına girdiğinde uygulanmak zorundadır. FMEA 2’ye ayrılmaktadır: Tasarım FMEA ve Proses FMEA. FMEA kitabını yayınlamasının ana sebepleri: 1.OEM’nin yüksek kalite beklentisi, 2.Ürünlerde ve proseslerde maliyet optimizasyonu, 3.Yüksek adetli karışık proseslerin artışı, 4.Yönetmeliklerle gelen ürünlerin yükümlülükleri. FMEA Metodu, sistematik bakış açısı ile, ekip çalışması ile, nitel ve nicel yaklaşımlarla ve analitik yaklaşımlarla yapılabilmektedir. FMEA çalışmalarının amaçları ise: 1.Ürün veya proseslerde olabilecek potansiyel risklerin teknik açıdan değerlendirilmesi, 2.Potansiyel risklerden olabilecek hataların nedenlerinin ve etkilerinin analizi, 3.Bu hataları önleyebilmek ve önceden saptayabilmek için yapılacak faaliyetlerin dokümante edilmesi, ...

PSCR: PRODUCT SAFETY & CONFORMITY REPRESENTATIVE Product safety and conformity representative comes from the standard of IATF 16949: 2016 4.4.1.2 item (product safety). The basic goal is to keep and under control, product safety and conformity according to the customer need legal/local regulations, and laws. The critical goal is to ensure its effective implementation. Product Safety & Conformity Representative is assigned by the organization. From start to production to end of the production (THROUGHOUT THE PRODUCT LIFE CYCLE), product safety & conformity representatives responsible for working together and a coordinate bond to the related departments and processes. According to correct and suitable use instructions or during the intended use, if a product is not dangerous for user’s safety, then product safety and conformity representatives can confirm to the market. In an organization, to assign product safety and conformity representative, staffs should get ...