How do pharmaceutical companies audit suppliers?

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Supplier audit is the performance evaluation and annual quality system audit of existing suppliers, and it is an important content in the process of supplier management. It is based on the investigation and analysis of the supply market and the preliminary screening of potential suppliers. Supplier quality system audit is an important aspect of supplier audit. Because quality management occupies a special and important position in enterprise management, general companies often list supplier quality system audit separately. Of course, it can also be used as a part of supplier audit together with supplier audit according to the situation.

According to the maturity of different material suppliers, supplier audit can be arranged before, during and after supplier certification, with the purpose of confirming and screening the best suppliers, optimizing supplier structure and improving competitive advantage.

Level of supplier audit

As far as the control level of procurement and supply is concerned, supplier audit can be limited to product level, process level, quality assurance system level, and even the overall management system level of suppliers (company level).

(1) product hierarchy. Mainly to confirm and improve the quality of suppliers' products. The implementation method includes product or sample approval inspection before formal supply and incoming material quality inspection during supply.

(2) Process level. This level of audit is mainly aimed at those products whose quality strongly depends on the production process. In order to ensure the reliability of supply quality, it is often necessary to go deep into the supplier's production site, understand its technological process, and confirm that its technological level, quality control system and corresponding equipment and facilities can meet the product quality requirements. This level of audit includes the review of the process and the confirmation and adjustment of the supplier's on-site process due to the unstable quality in the supply process.

(3) the level of quality assurance system. This is an audit of the supplier's entire quality system and process with reference to ISO9000 standard or other quality system standards.

(4) at the company level. Company-level audit is the highest level of supplier audit, which not only examines the supplier's quality system, but also reviews the management processes of major enterprises such as supplier management level, financial and cost control, planned manufacturing system, information system and design engineering capability.

In fact, for ordinary commercial suppliers, buyers are generally limited to product level and process level audit, but if buyers want to choose partners, the situation is different, especially for those international large companies with strict management and advanced technology, who usually use quality assurance system and company level audit to control the supply chain management system.

Supplier audit method

The main methods of supplier audit can be divided into subjective judgment and objective judgment. The so-called subjective judgment method refers to the judgment of suppliers based on personal impression and experience, which lacks scientific standards and has a very general and vague basis; Objective judgment method refers to the quantitative evaluation and recognition of suppliers according to pre-established standards or guidelines, including investigation method, on-site scoring evaluation method, supplier performance evaluation method, supplier comprehensive audit method, total cost method and so on.

(1) survey method. Survey method refers to the method of preparing some standard survey forms in advance, sending them to different suppliers to fill in, and comparing them after recycling. This method is often used in bidding, price search and preliminary understanding of supply situation.

(2) On-site scoring appraisal method. On-site scoring evaluation method is a method of preparing some questions and formatting them in advance, and then organizing professionals from different departments to check and confirm at the supplier site.

(3) Supplier performance evaluation. Supplier performance evaluation refers to the tracking, evaluation and examination of the supply situation, quality and price of existing suppliers that have already supplied.

(4) Comprehensive evaluation of suppliers. The comprehensive audit of suppliers is a comprehensive audit organized at the company level of suppliers, including quality, engineering, planning, procurement and other professionals. Usually, questionnaire survey and on-site audit are combined.

(5) Overall cost method. Total cost method is a method to reduce the overall cost of suppliers to a new level, thus reducing the purchase price. It needs the full cooperation of suppliers. The buyer organizes a strong comprehensive expert team to conduct a comprehensive and detailed analysis of the suppliers' finance and costs, find out the methods to reduce costs, and ask the suppliers to implement and improve them. The improved benefits will be shared by both parties.

Supplier audit procedure

1) Market research, collecting supplier information.

Supplier audit is based on the investigation and analysis of the supply market. Investigating the supply market and collecting information and data of suppliers are the premise of audit. Only by mastering the detailed information of suppliers can we make an objective and fair audit of suppliers. In the stage of market research, the information of suppliers is mainly collected from the market distribution of suppliers, the quality and price of purchased goods, the production scale of suppliers and so on.

2) Determine the main indicators of supplier audit.

Different suppliers have different audit indicators. We should formulate specific audit indicators for the audited suppliers according to the actual situation of suppliers and the characteristics of goods purchased by our unit.

3) Establish a supplier audit team.

The audit of suppliers should set up corresponding audit teams according to different procurement projects. For some standard products and projects with relatively low amount, the purchasing personnel can form an audit team by themselves. This way is the simplest, fastest and most convenient; For non-standard products and large-value projects, cross-functional groups or commodity groups can be set up to perform audit tasks. The so-called cross-functional group refers to a temporary supplier audit organization composed of purchasing department, quality department, material management department, engineering R&D department, supervisor or finance department according to the nature of the purchased goods.

4) Comprehensive score

The final step of supplier audit is to comprehensively score suppliers. For each audit project, weigh the importance of each other and give different scores. After the audit team determines the audit content and weight of the supply, it can prepare the supplier qualification score table according to the supplier's questionnaire feedback and field survey data.

Contents of supplier audit

Due to the differences of suppliers' own conditions (each has its own advantages and disadvantages), there must be objective scoring items as the basis for selecting qualified suppliers. Therefore, the supplier audit should formulate detailed audit contents, which usually include the following items.

(1) supplier operation status. It mainly includes the supplier's business history, qualification of the person in charge, registered capital, number of employees, completion records and performance, major customers and financial status.

(2) The production capacity of suppliers. It mainly includes whether the supplier's production equipment is advanced, whether the production capacity is fully utilized, the space distance of the factory building, and whether the manpower for production operation is sufficient.

(3) technical ability. It mainly includes whether the supplier's technology is developed by itself or imported from abroad, whether it cooperates with internationally renowned technology development institutions, technical evaluation of existing products or trial-produced products, product development cycle, number of technicians and education level, etc.

(4) management system. It mainly includes whether the production process is smooth and reasonable, how the output efficiency is, whether the material control is computerized, whether the production plan changes frequently, and whether the purchasing operation provides a good basis for cost calculation.

(5) Quality management. It mainly includes the quality management principles and policies, the implementation of the quality management system, whether there is a quality management system manual, whether there is a quality assurance operation plan, whether there is an annual quality inspection target, whether there is an evaluation level of political institutions, and whether it has passed the ISO9000 certification.