制药业PSCI验厂辅导|对企业内外部评估检查与管理设定绩效目标与纠正措施

Management Systems

Suppliers shall use management systems to maintain business continuity, facilitate continual improvement and compliance with the expectations of these principles. The Management System elements include:

1. COMMITMENT ANDACCOUNTABILITY

Suppliers shall demonstrate commitment to the concepts described in this document by allocating appropriate resources and identifying senior responsible personnel.

2. LEGAL AND CUSTOMER REQUIREMENTS

Suppliers shall identify and comply with applicable laws, regulations, standards and relevant customer requirements.

3. RISK MANAGEMENT

Suppliers shall have mechanisms to determine and manage risks in all areas addressed by these Principles.

4. DOCUMENTATION

Suppliers shall maintain documentation necessary to demonstrate conformance with these Principles and compliance with applicable regulations.

5. TRAINING ANDCOMPETENCY

Suppliers shall have a training program that achieves an appropriate level of knowledge, skills and abilities in management and workers to address the expectations in these Principles.

6. CONTINUAL IMPROVEMENT

Suppliers are expected to continually improve by setting performance objectives, executing implementation plans and taking necessary corrective actions for deficiencies identified by internal or external assessments, inspections, and management reviews.

7. IDENTIFICATION OFCONCERNS

All workers shall be encouraged to report concerns, illegal activities or breaches of these Principles in the workplace without threat of or actual reprisal, intimidation or harassment. Suppliers shall investigate and take corrective action if needed.

8. COMMUNICATION

Suppliers shall have effective systems to communicate these Principles to workers, contractors and suppliers.

管理体系

供应商应借助管理系统来维持业务连续性、促进持续改进并遵守本原则所述要求。管理系统原则包括以下要素：

1. 承诺和责任

供应商应部署适当的资源、任命高级管理人员，切实履行对本原则所述要求的承诺。

2. 法规和客户要求

供应商应明确并遵守适用的相关法律、规章、标准以及相关的客户要求。

3. 风险管理

供应商应该建立相关机制，对本原则涉及的各个领域的风险予以识别和管理。

4. 文档记录

供应商应保留必要的文档记录，以证明其遵循本原则并遵守相关规章制度。

5. 培训和能力

供应商应建立培训制度，使管理层和员工获得实现本原则要求所需的一定水平的知识和技能。

6. 持续改进

供应商应通过设定绩效目标、执行实施计划并且针对内部或外部评估、检查和管理审查中发现的缺陷采取必要的纠正措施，从而实现持续改进。

7. 发现问题

应当鼓励所有员工举报工作场所中的问题、违法活动或违反本原则的行为，同时不会受到报复、恐吓或骚扰的威胁。供应商应展开调查，并在必要时采取纠正措施。

8. 沟通“原则”

供应商应建立有效的系统，向员工、承包商和其供应商沟通本原则内容。