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Inspection Report & Review
检查报告和审查

Doc. Nr
文档编号

TI-CN 61
TI-CN61

Rev. Date
修订日期

29.08.2024

Rev. Nr

00

Page

6/6

Purpose:
目的:

This instruction was prepared for the purpose of ETKO staff members to have a better understanding of reporting evaluation results for further processes of review and certification. It outlines briefly for assigned staff members how the process is to be realized in general. The last section of the instruction details some of the important aspects of the certification programs that inspectors keep in mind.
本说明旨在让 ETKO 工作人员更好地了解报告评估结果,以便进一步进行审查和认证。它为指定的工作人员简要概述了如何实现该过程。说明的最后一部分详细介绍了检查员牢记的认证计划的一些重要方面。

Application:
应用:

ETKO staff members assigned for Application, Application Review, Evaluation, Evaluation results review, and certification decision are responsible for following the rules explained in this instruction.
负责申请、申请审查、评估、评估结果审查和认证决定的 ETKO 工作人员负责遵守本说明中解释的规则。

Documents used for reporting purposes:
用于报告目的的文件:

Application Evaluation Checklist: The customer service staff uses this form (GP-CN 02 F 06 Application Evaluation Checklist OBP Program) to initially evaluate the application submitted by the organization.
应用程序评估清单: 客服人员使用此表格(GP-CN 02 F 06 Application Evaluation Checklist OBP Program)对组织提交的申请进行初步评估。

Audit Checklists: For each program, ETKO has one checklist available. This is the inspection report inspector evaluates the application package of the operator and registers evaluation results.
审计清单: 对于每个程序,ETKO 都有一个可用的清单。这是检查报告检查器,用于评估操作员的应用程序包并登记评估结果。

Labeling Release or Assessment Form: According to the scope there are different forms available for the purpose of label approvals (i.e. GP-CN 24 F 26 Claim Application and Approval Form OBP). This form is prepared by the operator and ETKO staff who is responsible for the label assessment approves it.
标签放行或评估表:根据范围,有不同的表格可用于标签审批(即 GP-CN 24 F 26 索赔申请和批准表 OBP)。此表格由操作员准备,负责标签评估的 ETKO 工作人员批准。

Application Package Review form: This form is prepared before the audit based on the application documents provided by the client (i.e. GP-CN 02 F 02 Application Pack Review Form OBP Program). The points that need to be taken care of during the audit are indicated in this form. There are different forms for different scopes. The APR is sent to the client before the audit to inform them regarding whether the audit can be conducted.
申请包审核表:此表是在审核前根据客户提供的申请文件(即 GP-CN 02 F 02 Application Pack Review Form、OBP Program)准备的。此表格中指出了审计期间需要注意的要点。不同的范围有不同的形式。APR 在审计之前发送给客户,以告知他们是否可以进行审计。

OP 01 F 37 Attendance Record: Use this form to register the participants during the opening and closing meetings.
OP 01 F 37 出席记录:使用此表格在开幕式和闭幕式会议期间登记参与者。

Noncompliance Register: The Inspector registers findings into this form (i.e. GP-CN 14 F 02 Noncompliance Register OBP Program) and provides it to the certifier to evaluate for a final decision before notifying the results of the operator.
不合规登记册:检查员将调查结果登记到此表格中(即 GP-CN 14 F 02 不合规登记册 OBP 计划),并将其提供给认证机构进行评估,以便在通知运营商的结果之前做出最终决定。

Review Report: The Certifier prepares this form (i.e. OP-CN 01 F 02 Review Report) based on the inspector’s and file reviewer’s findings. It contains reminders and still not closed NCs, or points of attention.
审核报告:审核员根据检查员和文件审核员的调查结果准备此表格(即 OP-CN 01 F 02 审核报告)。它包含提醒和仍未关闭的 NC 或关注点。

Certification Decision: File reviewer/ Certifier prepares this form (OP-CN 01 F 32-A Certification Decision Form OBP Program) as a final check if the file was completed, and he passes it for certification. If it passes the evaluation certifier issues the certification decision.
认证决定:文件审查员/认证者准备此表格(OP-CN 01 F 32-A 认证决定表 OBP 程序)作为文件是否完成的最终检查,并通过认证。如果通过评估,则验证者将发出认证决定。

OP 03 F 01 Sampling Form: The Inspector takes samples in case required by the certification program according to Risk Assessment. The form must be completed fully including the quantity of the product sampled, place of sampling, seal numbers, witness, and signatures.
OP 03 F 01 取样表:检查员根据风险评估,在认证计划要求的情况下取样。该表格必须完整填写,包括抽样商品的数量、抽样地点、封条编号、见证人和签名。

Inspection Detail Plan: The Inspector prepares the plan (i.e. OP-CN 05 F 04 Inspection Detailed Plan OBP Program) and sends it to the client before the audit to verify it and prepare their operation for evaluation.
检查详细计划:检查员准备计划(即 OP-CN 05 F 04 检查详细计划 OBP 计划)并在审计前将其发送给客户进行验证并准备他们的操作进行评估。

File review checklist: File Reviewer and/or certifier evaluates the audit file package and records the findings/comments using this form (i.e. OP-CN 01 F 34-A Inspection File Review Checklist OBP Program), and then sends it to the inspector in case of any corrections and confusions in the audit file package. The inspector is notified by this form to correct and/or provide the missing information.
文件审查清单:文件审查员和/或认证者评估审计文件包并使用此表格(即 OP-CN 01 F 34-A 检查文件审查清单 OBP 程序)记录结果/评论,然后将其发送给检查员,以防审计文件包中出现任何更正和混淆。此表格会通知检查员更正和/或提供缺失的信息。

OP 01 F 16 Control Notes: The Inspector uses this form for taking notes, opening/closing meetings, and results of the inspections. Reviewer / Certifier checks the notes taken by the inspector.
OP 01 F 16 控制说明:检查员使用此表格做笔记、开始/结束会议和检查结果。Reviewer / Certifier 检查检查员的笔记。

Instruction for Inspection Report
检验报告说明

The inspector must submit the inspection reports promptly, providing sufficient time for review and the final certification decision to be made.
检查员必须及时提交检查报告,为审查和做出最终认证决定提供足够的时间。

Upon completion of the inspection, the inspection report is completed showing the results, results are registered in the NCR form to provide review and certification decision. This is important in providing sufficient time for review and the final certification decision to be made.
检查完成后,完成检查报告,显示结果,结果登记在 NCR 表格中,以提供审查和认证决定。这对于提供足够的时间进行审核和做出最终认证决定非常重要。

Nonconformity reports are prepared when any nonconformity is observed. To describe the nonconformity including the reference number of the NCs to be carefully prepared and presented to the client with NCR.
当观察到任何不合格项时,将准备不合格报告。描述不符合项,包括需要仔细准备并与 NCR 一起提交给客户的 NC 的参考编号。

The inspection ended in the closing meeting with the management team of the client, in which the observations and nonconformities were communicated to the client.
检查在与客户管理团队的结束会议中结束,在会议上,观察结果和不符合项被传达给客户。

Following the audit, even if the file is missing documents expected from the customer, it is forwarded to the certification department within the period specified in the TI 65 instruction in order to initiate the file review process and to follow up these missing documents by the certification department.
审核后,即使文件缺少客户期望的文件,也会在 TI 65 指令规定的期限内转发给认证部门,以便启动文件审查流程并由认证部门跟进这些缺失的文件。

Reporting Technics:
报告技术

Inspectors and other staff members reviewing the files make sure assessment results provide actual information for each control point. Justification is made before validation of each point, whereas non- compliant further explanation or evidence to be asked from the operator.
检查员和其他工作人员审查文件,确保评估结果提供每个控制点的实际信息。在验证每一点之前进行理由说明,而不合规的则向操作员索取进一步的解释或证据。

For any type of audit usually inspectors do not have enough time for reporting on site, eventually reporting is finalized after the audits. Inspectors focus on the site more to identify the problems raising nonconformities and collect objective evidence. Therefore, they may have problems finalizing the reports within a short time after the audits. So, the inspector finalizes his report without having a fresh view of the assessments done, even some information might be lost since the audit is done.
对于任何类型的审核,检查员通常都没有足够的时间在现场报告,最终在审核后最终确定报告。检查员更多地关注现场,以识别引起不合格项的问题并收集客观证据。因此,他们可能无法在审计后的短时间内完成报告。因此,检查员在没有对已完成的评估有新视图的情况下完成了他的报告,甚至一些信息也可能在审计完成后丢失。

It is essential to spend time for every control point to understand what the requirement is and then answer the question as appropriate. Answers must provide objective evidence to the file reviewer/certifier in order to proceed for certification.
必须花时间了解每个控制点的要求是什么,然后适当地回答问题。答案必须向文件审阅者/验证者提供客观证据,以便继续进行认证。

Inspector and/or file reviewers must keep in mind when providing answers for each control point satisfying the standard requirements address and explain the following items:
检查员和/或文件审阅者在为每个控制点提供满足标准要求的答案时,必须牢记:解决并解释以下项目:

Condition (What is the problem with this control requirement?) What is the meaning of the control point
条件(此控制要求有什么问题?控制点的含义是什么

Criterion (What policy or best practice can be adopted properly explain this control point?).
标准 (可以采用什么政策或最佳实践来正确解释这个控制点?

Cause (What led to the problem if the control point was not explained as required?)
原因(如果未按要求解释控制点,是什么导致了问题?

Effect (What is the risk in case not answered sufficiently?)
效果(如果回答不充分,有什么风险?

Recommendation (What should be done?, Raise an issue, NC, Observation?)
建议 (What should be do?, Raise an issue, NC, Observation?)

However, every inspector has a different character which reflects the reporting which may create confusion for the reviewer. In the end, the decision taken may cause severe damage to the operator. Therefore, ETKO takes measures:
但是,每个检查员都有不同的特征来反映报告,这可能会给评论者带来混淆。最后,所做的决定可能会对操作员造成严重损害。因此,ETKO 采取了以下措施:

To reduce improper implementation of the reporting requirements ETKO to take precautions such as rotating different inspectors to verify the same operators’ specific situations in shorter periods. Rotating the inspector may increase the quality of assessment and reporting.
为了减少报告要求的不当执行,ETKO 采取了预防措施,例如轮换不同的检查员,以在更短的时间内验证同一操作员的具体情况。轮换检查员可能会提高评估和报告的质量。

Providing visual evidence such as pictures, samples of a product, or a part of the documentation system when the inspector having difficulty reporting.
当检查员难以报告时,提供视觉证据,例如图片、商品样品或文档系统的一部分。

The checklists might be updated on a regular basis when there are issues related to understanding the control points by the staff members.
当工作人员存在与理解控制点相关的问题时,检查表可能会定期更新。

Control points might be formulated comprehensive way allowing the inspector understanding to provide answers accordingly. When required a better way for questioning or explanatory note might be provided for the inspector's judgments for specific questions.
控制点可以以全面的方式制定,使检查员的理解能够相应地提供答案。如有需要,可为检查员对特定问题的判断提供较佳的提问方式或解释性说明。

High Risk Situations:
高风险情况:

ETKO amend and adapt its certification procedure to address higher risks found in certain situations
ETKO 修改和调整其认证程序,以应对在某些情况下发现的更高风险

specific to the standard’s certification.
特定于标准的认证。

Potential High-Risk Situations and Related Measures Include
潜在的高风险情况和相关措施包括

In case of parallel production of certified and non-certified products present within the same facility, ETKO verifies whether handling and documentation regarding (wet-) processing, storage, and sales is well managed through trained personnel and makes clear distinctions between certified and non- certified products in order to prevent co-mingling or confusion of certified products with other products that do not meet the standards. In cases where products are not visibly distinguishable, operator(s) should apply specified measures to reduce the risk.
如果在同一设施内同时生产认证和非认证产品,ETKO 会验证是否通过训练有素的人员对有关(湿法)加工、储存和销售的处理和文件进行妥善管理,并明确区分认证和非认证产品,以防止认证产品与其他不符合标准的产品混合或混淆。在产品无法明显区分的情况下,运营商应采取特定措施来降低风险。

ETKO checks production sites, stores, and other departments of the production unit where certified products are handled, processed, kept, packed, and dispatched, with good practice for identification, separation, and segregation against the risk of contamination, commingling possible. The precautionary measures must prevent physical co-mingling or confusion of certified products with other products that do not meet the standards. The documentary accounts used must provide clear separation and identification of certified and non-certified products throughout the product handling within the facility.
ETKO 检查处理、加工、保存、包装和发送认证产品的生产地点、商店和生产单位的其他部门,并采用识别、分离和隔离的良好实践,以防止污染风险,并可能混合。预防措施必须防止认证商品与不符合标准的其他商品发生物理混淆或混淆。在工厂内处理商品的整个过程中,所使用的跟单账户必须清楚地区分和识别认证和非认证商品。

Documentary accounts is verified how they are implemented throughout the manufacturing, formulation, storage, and sales of incoming raw material until dispatch as finished product. Documents kept for each step of the processing and handling of certified products must have a clear indication of an ID number, certified status, content of the certified material, and standard reference. All practices implemented should make clear distinctions between certified and non-certified products during the entire processing, handling, and sales operation.
验证跟单账户在原材料的制造、配方、储存和销售过程中的实施方式,直到作为成品发货。为认证商品的加工和处理的每个步骤保留的文件必须清楚地标明 ID 号、认证状态、认证材料的内容和标准参考。在整个加工、处理和销售操作过程中,实施的所有实践都应明确区分认证和非认证商品。

The packing material used during all stages of the production to be verified carefully whether the identification of the products in place and packing material used is able to prevent product integrity against any risks.
在生产的所有阶段使用的包装材料都要仔细验证产品的标识和使用的包装材料是否能够防止产品完整性免受任何风险。

Where an operator is certified for a Standard that shares the same scope (e.g. recycled content for OBP and another standard that recognizes recycled content), ETKO ensures that material is not double- counted and that it is tracked appropriately. If the other scope certificate is with another certification body, ETKO seeks information exchange to prevent misuse of certificates.
如果运营商获得了具有相同范围的标准认证(例如 OBP 的回收内容和另一个认可回收内容的标准),ETKO 确保材料不会重复计算,并对其进行适当的跟踪。如果其他范围证书由另一个认证机构提供,则 ETKO 会寻求信息交换以防止滥用证书。

ETKO identifies the risk level of the operations according to Risk Analyses (i.e. TI-CN 47 Risk Assessment Form for OBP Program) in order to take necessary measures as explained in this procedure. Risk analyses are important to practice describing where certain operations have particular high-risk situations specific to product certification.
ETKO 根据风险分析(即 OBP 计划的 TI-CN 47 风险评估表)确定操作的风险级别,以便采取本程序中解释的必要措施。风险分析对于描述某些操作在哪些情况下具有特定于产品认证的特定高风险情况的实践非常重要。

Subcontracted facilities:
分包设施:

A certified operator demands a service from another handler/processor for a specific service including production/handling of a product while the ownership of the product remains with the certified operator. Subcontracting is used by certified operators as a usual practice, which could be very complex in certain situations, to follow the product supply chain. As a requirement of the regulations and private standards product flow from the raw material up to finished products to be inspected to safeguard product integrity. Inspection of every step of processing and handling operations under certification is mandatory. Additionally, operators should be under a certification cycle in order to produce and trade certified products. Therefore, ETKO follows the subcontracted facilities carefully for their specific tasks for certified materials.
认证操作员要求另一个处理商/加工商为特定服务提供服务,包括产品的生产/处理,而产品的所有权仍属于认证操作员。认证运营商将分包作为一种常规做法使用,在某些情况下可能非常复杂,以遵循产品供应链。作为法规和私人标准的要求,产品从原材料流向成品都要接受检查,以保证产品的完整性。必须检查加工的每一步和认证下的处理操作。此外,运营商应遵守认证周期,以便生产和交易认证产品。因此,ETKO 会仔细跟踪分包工厂完成认证材料的具体任务

Specific instructions for OBP program:
OBP 程序的具体说明:

Subcontractors are not obliged to become certified under this program, however it is likely that their production site(s) will be visited during an Audit of the Organization.
分包商没有义务根据该计划获得认证,但在组织审核期间,他们的生产地点可能会被访问。

For OBP-COL-STD, OBP-NEU-STD and OBP-REC-STD, ETKO will perform a risk assessment of Subcontractors, and if any are considered high risk, a sample of them will be inspected.
对于 OBP-COL-STD、OBP-NEU-STD 和 OBP-REC-STD,ETKO 将对分包商进行风险评估,如果任何分包商被视为高风险,将检查他们的样本。

The resulting Subcontractor group considered to present a high risk will be sampled using the square root methodology, rounded upwards to the following integer.
将使用平方根方法对被认为存在高风险的分包商组进行抽样,向上舍入到以下整数。

Once the sample size (how many) to be audited has been determined, the following step is to select the composition of sample that will be audited (which). 25% of the determined sample shall be selected randomly (always rounding upwards to the following integer). The remainder of the sample will be non-random, and specifically chosen to cover the greatest variety of cases. Maximum sample size for subcontractors operations: 6 Subcontractors.
一旦确定了要审计的样本量(多少),下一步就是选择将要审计的样本的成分(哪个)。应随机选择 25% 的确定样本(始终向上舍入到以下整数)。样本的其余部分将是非随机的,并且专门选择以涵盖最大种类的情况。分包商操作的最大样本量:6 个分包商。

For OBP-PRO-STD, subcontractors are not necessary to be physically visited by ETKO. Instead, document control according to the criteria specified in the standard is sufficient.
对于 OBP-PRO-STD,ETKO 无需亲自访问分包商。相反,根据标准中指定的标准进行文档控制就足够了。

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