BRC標準文
Senior Management Commitment and Continual Improvement
Fundamental Clause
The company's senior management shall demonstrate that they are fully committed to the implementation of the requirements of the Global Standard for
Consumer Products (referred to as The Standard).This shall include provision of adequate resources,effective communication, systems of review, and actions taken to identify and effect opportunities for improvement.
款產品類別
要求
1.1
所有公司的高層管理須確保產品的安全性和質量目標得以建立,記錄,監測,并每年至少評審一次。The
company’s senior management shall ensure that product safety and quality objectives are established,documented, monitored, and reviewed at least annually.1.2
所有評審過程需被文件化并須包括評價以下內容:•內部審核,客戶審核和外部審核
•以往管理評審的記錄,糾正措施和時間框架•客戶業績指標,投訴和反饋•事故,不符合物料和糾正措施•針對過程績效的評估
•針對產品風險評估體系的評審•針對監視和測試結果的評審
•與產品範圍內有關的法律要求或科技信息的進展•資源要求
The senior management review process shall be
documented and shall include an evaluation of: Internal,customer, and external (third party) audits;
previous management review documents, corrective action plans, and timeframes;
customer performance indicators, complaints, and feedback;
incidents, non-conforming materials and corrective actions;
an assessment of process performance;
a review of the product risk assessment system;a review of the results of monitoring and testing;developments in legal requirements or scientific information associated with the products in scope;resource requirements.1.3
所有需將商定的決定和措施有效地通知有關員工,並且在商定的時間期限內執行該措施。須更新記錄,以顯示措施何時完成。
The decisions and actions agreed shall be effectively communicated to appropriate staff and the actions implemented within the agreed timescales. Records should be updated to show when actions have been completed.
1.4
所有公司的高層級管理須提供實施和改進質量管理體系,產品風險評估計畫所需的人力資源和財力資源,并解決產品合法性,安全性和產品質量問題。
The company's senior management shall provide the human and financial resources required to implement and improve the processes of the quality management system, the product risk assessment
plan, and to address legal, product safety, and product quality matters.1.5
所有公司須有清晰的溝通和定期彙報的渠道,使得負有相應責任的員工可以向高層管理彙報本標準的功能和標準的符合情況。此彙報須包括改進的建議。
There shall be clear communication and regular
reporting of the functioning of, and compliance with, the Standard to senior management by the staff responsible.This shall include suggestions for improvement.1.6
所有
公司需具有本標準的當前版本的原件。
The company shall have a current, original copy of the Standard available on site.
1.7
1和2在法律要求的情況下,場所須在相關的政府機關註冊或審批,且須取得相應證明。
Where required by legislation, the site shall be registered with or approved by the appropriate governm
ent agency and evidence of this shall be available.
Risk Management
Fundamental Clause
高層管理承諾和持續改進
公司的高層管理層須能證明其充分承諾實施《全球消費品標準》的要求。這須包括提供充足的資源,有效地溝通,對體系進行評審和採取行動抓住改進的機會。
基本要求
風險管理
基本要求
12
The company shall have a management process in place
to assure product safety, legality and quality, based on
risk assessment principles. Sites must be aware of and
refer to up-to-date legislation, product standards, codes
of practice, and developments in science or technology
that may impact risk concerning their products and
packaging where these exist in the regions of intended
sale.
2.1產品範圍和類別的確定Product Scope and group determination
款產品
類別
要求
2.1.1所有公司須識別它希望包括在認證範圍內的產品範圍,
以及產品將要銷往的國家/州或地區。
The company shall identify the range of products it
wishes to include in the scope of certification and the
countries/states or regions for which the products are to
be made available for sale.
2.1.2所有公司頇根據判斷樹中標示的問題(見第二部份,
3.4),建立和記錄其範圍內的產品類別。
The company shall establish and document the product
group(s) assigned to the products in scope, derived from
application of the questions indicated in the decision tree
(see The Standard Section II, 3.4).
2.2合法性和安全性要求
款產品
類別
要求
2.2.1所有公司頇擁有并使用一個可能包括內部和/或外部資源
的系統,來證明對產品銷售所在地區的所有法律,
產品標準,產品安全性問題,科技發展和行業/客戶
的行為準則的瞭解。
The company shall have and use a system, which may
comprise internal and/or external resources, to
demonstrate knowledge of all legislation, product
standards, product safety issues, scientific and technical
developments, and industry/customer codes of practice in
the regions of intended sale relevant to the products in
scope.
2.2.2所有如果公司依賴于由客戶或相關方提供的關於產品安
全性,質量和合法性的信息,頇確認所收到的信息
和有效性并文件化該確認過程。
If the company relies on information concerning product
safety, quality, and legality provided by their customer or
related party, it shall validate the information received
and document the validation process.
2.2.3所有頇有文件化的過程可以將法律和標準等方面的變化
及時納入到公司的程序中,此過程頇在相關變更的
官方實施日期之前完成。
A documented process shall exist for incorporating
changes in legislation, standards, etc. into the company’s
procedures in a timely fashion, which shall be before any
official implementation date of the relevant change.
2.2.4所有適用法律、標準、行為準則和類似文件的副本頇提
供給相關員工。
Copies of applicable legislation, standards, codes of
practice, and similar documents shall be available to
relevant staff.
2.3生產之前的風險評估Risk assessment -prior to production
款產品
類別
要求
2.3.1所有含括每種產品的設計規範頇文件化,簽署日期和獲
得批准。頇包括所有相關信息。
作為指南,它可能包括以下內容,儘管這并非詳盡
的列表:
·成份、尺寸、顏
·材料單
·
組裝圖
·初包裝
·預期貨架存放期
·警告或使用指南
·使用、誤用、使用模式
·生產量
所有對產品設計的更改頇予以記錄并記錄日期。
A design specification covering each product shall be
documented, dated, and authorized. This shall include
all relevant information. As a guide, this may include the
following, although this is not an exhaustive list:
composition, size, color;
bills of materials;
assembly diagrams;
primary packaging;
intended shelf life;
warnings or instructions for use;
use, misuse, usage patterns;
productions volumes.
Any changes to the product design shall be documented
and dated.
公司須具有管理程序根據風險評估的原則來確保產品的安全性、合法性和質量。場所必須清楚并參考產
品銷售所在地區的最新法律、產品標準、行為準則和可能對產品和包裝有關風險產生影響的科學和技術的發展。
2.4產品風險評估的驗證Verification of the Product Risk Assessment
Management System
3.1方針聲明Policy statement
3.2一般性文件要求General Documentation requirement 3.2.1
文件控制
Documentation Control
The company's senior management shall ensure that all documents records, and data critical to the
management of product safety, legality and quality are in place and effectively controlled.
3.2.2記錄的完成和維護
Record Completion and Maintenance
3.2.3
說明書和技術信息檔案
Specification & Technical information dossiers
The company shall ensure that specifications exist for raw materials, components, and bought-in
components including packaging, intermediate/semi-processed, and finished products and any product or service that could affect the integrity of the finished product. A technical folder shall be established for 公司頇確保對於原料、組件和外購件,包括包裝,中間產品/半成品和成品,以及任何可能影響成品完整性的產品或服務有相應的規範。需為每種產品建立技術檔案。
公司的高層管理頇確保具備所有與產品安全性、合法性和質量有關的文件、記錄和數據,并得到有效管理。公司頇保持記錄以證明對產品的安全、合法性和質量實現有效的控制。
3.3組織結構、職責和管理權限
Organizational structure, responsibility, and management authority
The company shall have a clearly defined and
documented organizational structure that ensures the awareness of job function, responsibilities, and reporting relationships of key staff.
3.4內部審核
Internal Audit
The company shall audit the management system to 公司頇有清晰定義的和文件化得組織結構以確保關鍵員工瞭解工作職責、責任和報告關係。
公司頇審核管理體系已確保其符合性和恰當性。
3.4.2所有內審計畫頇由能勝任的審核員進行,審核員頇獨立
於被審核的操作領域。審核員不頇審核自己的工作
。
Internal audits shall be carried out by competent
auditors, who shall be independent of the area of
operation being assessed. Auditors shall not audit their
own work.
3.4.3所有糾正措施頇得到負責該措施的人員的正式同意,並
在適合和商定的時間框架內執行。
Corrective actions shall be formally agreed by the person
responsible for the action and implemented within
appropriate and agreed timescales.
3.4.4所有所有策劃的內部審核和相關糾正措施的記錄頇保
留,並且符合的和不符合項都需記錄下來。所有的
糾正措施頇被驗證以確保圓滿完成。
A record of all programmed internal audits and
associated corrective actions shall be maintained with
both conformity and nonconformity with the
requirements documented. All corrective actions shall be
verified to ensure satisfactory completion.
3.5採購、供應商核准和行為績效監控Purchasing, Supplier Approval and performance Review
The company shall control all purchasing processes which are critical to product safety, legality, and quality to ensure that procured products and services conform to defined requirements. In this context suppliers shall include subcontractors and home workers.
款產品
類別
要求
3.5.1所有公司頇有書面的供應商批准程序,包括提供影響產
品安全性、合法性或質量的產品、材料和服務的批
准的供應商列表。
頇建立此程序,包括進行持續評估的明確件和所
要求的績效表現標準。
The site shall have a documented supplier-approval
procedure, including a list of approved suppliers for
products, materials, and services impacting product
safety, legality, or quality.
Procedures shall be established which include clear
criteria for ongoing assessment and the standards of
performance required.
3.5.2所有公司頇在規定的“詴用”期限內根據已定義的件
評審新供應商的表現,此後基於規定的頻度來確定
後續供應商表現的監控級別。
The company shall review the performance of new
suppliers against defined criteria within a specified
"trial" period and thereafter at a specified frequency to
decide the level of ongoing supplier performance
monitoring.
3.5.3所有程序頇識別是否可以接收在緊急情況下或非正常情
況下使用未獲批准的供應商。如果可以,此程序頇
規定如何記錄和處理例外,以維持產品的安全性、
合法性和質量。
The procedure shall identify whether the use of
unapproved suppliers is acceptable under any emergency
or unusual situations. If this is the case, the procedure
shall define how exceptions are recorded and how they
are handled to maintain safety, legality, and quality of
the products.
3.6客戶財產Customer supplied property
The company shall exercise care customer property
(including intellectual property) while it is under the
company's control or is being used by the company.
款產品
類別
要求
3.6.1所有公司頇識別、驗證、保護和防護客戶財產,包括軟
件、知識產權和產品。如果客戶的任何財產發生丟
include中文失,損失或發現不適於使用的情況,頇向客戶報告
并保存記錄。
The company shall identify, verify, protect and safeguard
customer property including software, intellectual
property, tooling, fixtures, test equipment and products.
If any customer property is lost, damaged or otherwise
found to be unsuitable for use, this shall be reported to
the customer and records maintained.
3.7糾正和預防措施Corrective and Preventive Action
基本要求Fundamental Clause
The company's senior management shall ensure that
procedures exist to record, investigate, analyze, and
correct the cause of nonconforming products or
failure to meet standards, specifications, and
procedures which are critical to product safety,
legality, and quality.
款產品
類別
要求
公司的高層管理頇確保具備程序以記錄、調查、分析和糾正不符合的原因或者那些未能滿足對產品安全、合法性和質量至關重要的標準、規範和程序的不符合的原因。
公司頇控制對產品的合法性、安全性和質量至關重要的所有採購過程,以確保採購的產品和服務符合規定的要求。在此段內容中,供應商頇包括分包商和自由職業者。
當客戶的財產(包括知識產權)置於公司的控制之下時或被公司使用時,公司頇對顧客財產予以保護。
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