Seek the system document for “Outsourcing Process Control Procedure”

This post was last edited by CHFY on 2009-6-6 09:44 to provide one for reference! Outsourcing Control Procedure 1. Purpose To establish guidelines for controlling outsourcing processes in order to guide the selection, evaluation, and management of contractors used by the company, ensuring that these outsourcing processes are capable of meeting the company’s specified requirements. 2. Scope of Application Applies to all outsourcing processes of the company. The company’s outsourcing processes include: the painting process for plastic and machined parts, as well as the assembly process of AM2000:2008 dental treatment machines. 3. Responsibilities Procurement Department: Collects, searches for, and provides information on potential qualified contractors; oversees the evaluation and audit process of these contractors. Quality Department: Participates in the audit of contractors, leads the evaluation of their quality assurance capabilities, and is responsible for inspecting and verifying the quality of outsourced products. Technical Department: Participates in the audit of contractors, evaluates their technical capabilities and equipment; provides technical support to contractors when necessary. Production Department: Participates in the audit of contractors, evaluates their production capabilities, including material management and production process management. Representative of Management: Coordinates and plans the evaluation of contractors, compiles the results of these evaluations, and reports them to the general manager. 4. Terms and Definitions Potential Contractor: A supplier who wishes to provide services to the company but has not yet been utilized by the company. Qualified Contractor: A contractor who, after being investigated, evaluated, and selected by the company, possesses the capability to provide satisfactory services to the company. 5. Procedures Evaluation and Selection of Contractors 5.1.1 Principles for Selecting Contractors (a) A history of successful service delivery; sufficient production capacity and compliance with technical requirements ； (b) A good corporate credit rating, including quality management capabilities, services, resource allocation, or relevant system certifications, etc ； (c) Compare with the historical performance of similar services or with the experience of other users. (d) For contractors responsible for the entire system, it is necessary for them to obtain the relevant licenses from the regulatory authorities, and they must ensure compliance with all regulations applicable to the medical industry. 5.1.2 Regular evaluation and assessment of existing contractors (a) In principle, an overall evaluation of existing contractors should be conducted at least once a year. (b) The Purchasing Department is responsible for assessing the quality of the services provided by contractors as well as their level of cooperation, assigning scores based on factors such as timely delivery and pricing; the total score is 40 points, which is recorded in the “Regular Supplier Assessment Form”. (c) The Quality Inspection Department evaluates the contractors based on their quality performance and market feedback, as well as their responses to corrective actions; the total score is 60 points, which is also recorded in the “Regular Supplier Assessment Form”. (d) If the total score for a given year is less than 75 points, the contractor is given a warning along with requirements for improvement; if the score is less than 70 points, cooperation with that contractor is terminated. (e) After the evaluation is completed, the “Regular Supplier Assessment Form” is sent to the Operations Director or the Management Representative for approval. The Purchasing Department must keep this document for tracking purposes. 5.1.3 Evaluation and inclusion of potential contractors (a) The Purchasing Department is responsible for conducting written surveys or organizing on-site inspections to gain a preliminary understanding of potential contractors, and completing the “Supplier Evaluation Record” or “On-Site Supplier Inspection Form”. (b) The Quality Inspection Department checks the quality of the first batch of products produced by the potential contractor, completing the “Supplier Sample Evaluation Form” to ensure that the product quality meets the company’s requirements. (c) If necessary, a quality assurance agreement is signed with the contractor; such an agreement generally includes the following elements: (1) Requirements regarding the contractor’s quality assurance system ； (2) Set requirements for the quality of products processed by contractors and the inspection standards ； (3) Procedures for quality information exchange and dispute resolution 5.2 Control of outsourced processing 5.2.1 The technical department shall prepare the technical documents required for outsourcing, such as product standards and technical requirements. 5.2.2 The contractor must be able to provide evidence that meets the requirements of the quality assurance system; inspections may be conducted at the contractor’s facility from time to time to ensure that the outsourcing process is carried out under the conditions specified in the agreement. 5.3 Verification of outsourced processing 5.3.1 Inspectors shall inspect the products produced through outsourcing in accordance with the \"Product Inspection Guidelines\" and relevant inspection standards, or verify the accompanying inspection reports ； 5.3.2 When it is necessary to verify certain products at the supplier’s site, the procurement contract must specify the verification activities (standards and methods) ； However, customer verification does not exempt our company from its responsibility to provide customers with qualified products. 6. Relevant documents: Product Inspection Instructions 7. Records: Supplier Regular Assessment Form, Supplier Evaluation Records, Supplier On-site Inspection Form, Supplier Sample Evaluation Form 8. Attachments