PCB007 Magazine

PCB-Apr2018

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40 PCB007 MAGAZINE I APRIL 2018 ing including defining responsibilities, escala- tion processes, reaction plans. Corporate Responsibility Expands the leadership responsibilities to in- clude the requirement for an anti-bribery poli- cy, an employee code of conduct, and an ethics escalation policy to address increasing market and governmental expectations for improved integrity in social and environmental matters in the automotive industry. Risk Analysis There are additional requirements for risk analysis recognizing the continual need to an- alyze and respond to risk which consider spe- cific risks associated with the automotive in- dustry. You need to periodically review lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework, and implement action plans to ad- dress them. Plant, Facility and Equipment Planning Preventive maintenance is only the begin- ning. This updated section includes an in- creased focus on risk identification and risk mitigation, e valuating manufacturing feasibility, re- evaluation of changes in pro - cesses, and inclusion of on- site supplier activities. Man y risks can be avoid- ed by applying risk-based thinking during opera- tional planning activities, which includes optimiza- tion of material flow and floor space . Automotive-spe- cific capacity planning evalu- ation is required during manu- facturing feasibility assessments and must consider customer-con- tracted production rates and volumes, not only curr ent order levels. Total Productive Maintenance This section strengthens the requirement for equipment maintenance and overall proactive management of the total productive mainte- nance (TPM). TPM is a system for maintain- ing and improving the integrity of production and quality systems through machines, equip- ment, processes, and employees that add value to the manufacturing process. TPM should be fully integrated within the manufacturing pro- cesses and any necessary support processes. Metrics need to be more than on time comple- tion of PMs and these are inputs into Manage- ment Review. Documented maintenance objectives includ- ing but not limited to: • OEE (overall equipment effectiveness) • MTBF (mean-time-between-failure) • MTTR (mean-time-to-repair) Internal Auditor Competency This section features greatly-enhanced re- quirements to the organization's internal au- ditor competency to ensure a more robust in- ternal audit process. You must go much fur- ther than auditor internal training and need to establish a documented process that considers the competencies required by this clause, take actions to address any deficien- cies, assess the effectiveness of actions taken, and record a list of the approved auditors. Development of Products with Embedded Software This new clause, where applicable, adds require- ments for embedded soft- ware development and software development ca- pability self-assessments. If your company develops em- bedded software, you must have a process for quality assur- ance of products. The software de- velopment process must also be includ- ed within the scope of the internal audit pro- gram; the internal auditor should be able to understand and assess the effectiveness of the software development assessment methodolo- gy chosen by your organization.

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