品質管理系統中的設計與發展輸入要求

hlperng

產品研發過程中，設計與發展輸入是重要的工作項目，ISO 9001 規定的是一般要求(標準字體)，各個產業依其特性增修特別要求(斜體字體)，包括汽車產業的ISO/TS 16949、醫療器材產業的 ISO 13485、照護服務產業的IWA 1、航太產業的 AS 9100、電信產業的 TL 9000、軌道車輛產業 IRIS 等。由這些增修訂條文可知，大部高科技應用產業，其設計與發展輸入必須重視產品生命週期過程中的可靠度、維護度、與安全性等議題。

所有產業適用：
ISO 9001:2000 and 2008, Quality management systems - Requirements
7.3.2 設計與發展輸入 (Design and development inputs)
Inputs relating product requirements shall be determined and records maintained.  These inputs shall include:
a) 功能與性能要求 (functional and performance requirements)，
b) 適用的法令與規章要求 (applicable statutory and regulatory requirements)，
c) 適用時，根據先前類似設計推導得到的資訊 (where applicable, information derived from previous similar designs)，以及
d) 其他重要的設計與發展要求 (other requirements essential for design and development)。
這些要求必須經過審查確認它們的足夠性，要求必須是完整、清楚、且彼此之間不會互相衝突。(These inputs shall be reviewed for adequacy.  Requirements shall be complete, unambiguous and not in conflict with each other. )

汽車產業：
ISO 16949:2002 and 2009, Quality management - Requirements
7.3.2 Design and development inputs
Inputs relating product requirements shall be determined and records maintained.  These inputs shall include:
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.  
These inputs shall be reviewed for adequacy.  Requirements shall be complete, unambiguous and not in conflict with each other.  

注釋：第 7.2.1.1 節的特殊特性納入本項要求。[NOTE.  Special characteristics (see 7.2.1.1) are included in this requirement.]
7.3.2.1 產品設計輸入組織必須識別、建檔、及審查產品設計之設計輸入要求，包括下列項目：
- 顧客之要求（合約審查）：例如：特殊特性、識別、追溯性、及包裝。
- 資訊之使用：組織應該建立從先前設計專案、競爭對手分析、供應者回饋過程、內部輸入、現場資料、及其他相關來源等來源，展開相關資訊的過程，作為目前與未來類似本性的專案之用。
- 產品要求、壽命、可靠度、耐久度、維護度、時程、及成本的符合性目標。
7.3.2.2 製造過程設計輸入
組織必須識別、建擋、及審查製造過程之設計輸入要求，包括：
- 產品設計輸出資料，
- 生產力、過程能力、及成本的目標，
- 顧客要求，若有的話，以及
- 來自過去發展的經驗。
注釋：製造過程設計，包括使用適合問題規模及可以補償所遭遇到風險的防誤方法。
7.3.2.3 特殊特性
組織必須識別特殊特性，並且
- 包括納入控制計畫書中的所有特殊特性，
- 符合顧客規定的定義與符號，以及
- 識別過程控制文件，包括圖面、FMEA、控制計畫書、作業員指導書，將顧客的特殊特性符號或組織對等的符號或記號，納入影響特殊特性的過程步驟之中。
注釋：特殊特性包括產品特性及過程參數。
7.3.2.1 Product design input
The organization shall identify, document and review the product design input requirements, including the following:
- ustomer requirements (contract review) such as special characteristics (see 7.3.2.3), identification, traceability and packing.
- use of information: the organization shall have a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature.  
- targets for conformity to product requirements, life, reliability, durability, maintainability, timing and cost.  
7.3.2.2 Manufacturing process design input
The organization shall identify, document and review the manufacturing process design input requirements, including:
- product design output data,
- targets for productivity, process capability and cost,
- customers requirements, if any, and
- experience from previous developments.
NOTE.  The manufacturing process design includes the use of error-proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered.  
7.3.2.3 Special characteristics
The organization shall identify special characteristics [see 7.3.3 d)] and  
- include all special characteristics in the control plan,
- comply with customer-specified definitions and symbols, and
- identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer's special characteristic symbol or the organization's equivalent symbol or notation to include those process steps that affect special characteristics..
NOTE.  Special characteristics can include product characteristics and process parameters.



軌道產業：
IRIS 2001, International Railway Industry Standard
7.3.2 Design and development inputs
Inputs relating product requirements shall be determined and records maintained.  These inputs shall include:
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and  
d) other requirements essential for design and development.
The inputs shall be reviewed for adequacy.  Requirements shall be complete, unambiguous and not in conflict with each other.  
組織在將新技術/新產品（為滿足市場需要而作的設計）導入顧客專案之前，必須確保這些技術/產品已經完成確認。
可靠度、可用度、維護度、及安全性/生命週期成本必須當作設計輸入。
產品的壽命期限必須當作設計輸入。
注釋 1：有些特別的顧客會期望最終使用者，能夠蒐集與供應商的需要和需求有關的所有資訊，使供應商能夠擁有完整及可靠的設計輸入。

The organization shall ensure that new technologies / new Products (designed to meet market needs) are validated before introduction into a customer Project.
RAMS / LCC shall be considered as design inputs.
End of life of Products should be considered as design inputs.
NOTE 1.  In particular customers are expected to collect by the end users all the information needed and demanded by the supplier in order to enable the supplier to have complete and reliable design inputs.  


電信產業：
TL 9000 R3.0:2001 and R4.0, Quality Management System Requirements Handbook
Inputs relating product requirements shall be determined and records maintained.  These inputs shall include:
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and  
d) other requirements essential for design and development.
The inputs shall be reviewed for adequacy.  Requirements shall be complete, unambiguous and not in conflict with each other.  

7.3.2.C.1 顧客與供應商輸入
組織在發展新產品或更新產品要求時，必須建立與維護擷取及使用顧客與供應者輸入的方法。7.3.2.C.2 設計與發展要求定義與建檔設計與發展要求，這些要求應該包括：
- 品質與可靠度要求
- 營運、組織、與使用者要求
- 安全、環境、與保密要求
- 安裝度、使用度、與維護度要求
- 設計限制與測試要求
- 目標電腦的電腦資源
7.3.2.C.3 要求配當
建立從產品要求配當至產品架構的文檔。7.3.2.C.3 - 注釋：
應該配當的要求案例包括：軟體的反應時間、硬體的散熱、及服務的服務反應時間。
7.3.2.H.1 要求內容
產品要求包括，但不限於下列項目：標稱值與容差、維護度需要、及最終品項的打包要求。
7.3.2.S.1 軟體要求識別
決定、分析、與建檔系統中的軟體元件要求。
7.3.2.S.2 要求配當
組織應該建立從產品要求配當到產品架構的文檔。
7.3.2.C.1 Customer and supplier inputs
The organization shall establish and maintain methods for soliciting and using customer and supplier input during the development of new or revised product requirements.
7.3.2.C.2 Design and development requirements
Define and document the design and development requirements.  These requirements should include:
- Quality and reliability requirements
- Business, organizational, and user requirements
- Safety, environmental, and security requirements
- Installability, usability, and maintainability requirements
- Design constraints and testing requirements
- Computer resources for the target computer
7.3.2.C.3 Requirements Allocation
Document the allocation of the product requirements to the product architecture.  
7.3.2.C.3 - NOTE
Examples of requirements which should be allocated are response time for software, heat dissipation for hardware, and service response time for services.
7.3.2.H.1 Content of Requirements
Include product requirements for, but do not limit to, nominal values and tolerances, maintainability needs, and end-item packaging requirements.
7.3.2.S.1 Identification of Software Requirements
Determine, analyze, and document the software component requirements of the system.  
7.3.2.S.2 Requirement Allocation
The organization shall document the allocation of the product requirements to the product architecture.   

醫療器材產業：
ISO 13485:2003, Medical devices - Quality management systems - Requirements for regulatory purposes
7.3.2 設計與發展輸入
必須決定並維護產品要求相關輸入的紀錄。這些輸入必須包括：
a) 根據意圖使用決定的功能、性能與安全要求，(功能與性能要求)。
b) ... d)
e) 風險管理的輸出。
這些輸入必須審查其足夠性並核可。(這些輸入必須審查其足夠性。)要求必須完整、不模糊、且彼此不能相互衝突。
7.3.2 Design and development inputs
Inputs relating product requirements shall be determined and records maintained.  These inputs shall include:
a) functional, performance and safety requirements, according to the intended use, (functional and performance requirements,)
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development, and  
e) output(s) of risk management.
These inputs shall be reviewed for adequacy and approved. (The inputs shall be reviewed for adequacy.)  Requirements shall be complete, unambiguous and not in conflict with each other.  


醫療照護服務產業：
IWA 1, Quaity Management Systems - Guidelines for process improvement in health service organizations
7.3.2 Design and development inputs
Inputs relating product requirements shall be determined and records maintained.  These inputs shall include:
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.
These inputs shall be reviewed for adequacy.  Requirements shall be complete, unambiguous and not in conflict with each other.
7.3.2 Design and Development input and output
The organization should identify process inputs that affect the design and development of products and facilitate effective and efficient process performance in order to satisfy the needs and expectations of customers, and those of other interest parties.  These external needs and expectations, coupled with those internal to the organization, should be suitable for translation into requirements for the design and development processes.  
Examples are as follows:
a) external inputs such as
   - customer or marketplace needs and exptectations,
   - needs and expectation of other interested parties,
   - supplier's contributions,
   - user input to achieve robust design and development,
   - changes in relevant statutory and regulatory requirements,
   - international or national standards, and
   - industry codes of practices;
b) internal inputs such as
   - policies and objectives,
   - needs and expectations of people in the organization, including those receiving the output of the process,
   - technological developments,
   - competence requirements for people performing design and development,
   - feedback information from past experience,
   - records and data on existing processes and products, and
   - outputs from other processes;
c) inputs that identify those characteristics of processes or products that are crucial to safe and proper functioning and maintenance, such as:
   - operation, installation and application,
   - storage, handling and delivery,
   - physical parameters and the enviroment, and
   - requirements for disposal of the products.  
Product-related inputs based on an appreciation of needs and expectations of end users, as well as those of hte direct customer, can be important.  Such inputs should be formulated in a way that permits the product to be verified and validated effectively and efficiently.  
The outpu should include information to enable verification and validation to planned requirements.  Examples of the output of design and development include
   - data demonstrating the comparison of process inputs to process outputs,
   - product specifications, including acceptance criteria,
   - process specifications,
   - material specificaitons,
   - testing specifications,
   - user and customer information,
   - purchase requirements, and
   - reports of qualification tests.  
Design and development outputs should be reviewed against inputs to provide objective evidence that outputs have effectively and efficiently met the requirements for the process and product.  
NOTE.  Design in health service may include the creation or revision of care and service programs, guidelines, care paths, patient / client treatment parameters, research and treatment protocols, training materials, as well as customization or modification of devices and other products or procedures.  
7.3.2.1 Facility and equipment planning
The organization should use a multi-disciplinary approach for developing facility and equipment plans.  Plans should address patient/client privacy and safety, the need for sterilization and the prevention of infection as appropriate.  Facility layouts should minimize travel and handling.  The organization should ensure the ability of staff to monitor patient/client load.  
NOTE.  Consideration should be given to determination of the optimum size of facilities and equipment during the planning phase in order to achieve efficient operations.  
The organization should prepare contingency plans to resonably protect employees and customers in the event of emergency, such as utility interruption, key equipment failure, or extreme weather activity.  Plans should also address security and sound privacy.  
What to look for:
When an organization designs (does medical research and the outcome is a new pathway, protocol, or procedure) the requirements of element 7.3 apply.  When the organization develops a different way to implement a pathway, protocol, or procedure then the element 7.3 applies.  If the organization strictly applies known technolgy, protocols, pathway, or procedures then it may exclude element 7.3 of ISO 9001.  See the explanation above about a surgeon learning a new procedure.  
Facility plans should be documented.  Applicable documents include for floor plans, RASIC or RASCI chart (which define roles and responsibilities), work or job instructions, Failure Mode and Effects Analysis (FMEA) forms, visual controls, meeting minutes, ergonomic studies, preventive maintenance plans and records, equipment manuals supplied from the manufacturere or supplier, internal audit records, characteristic matrices, emergency preparedness drill plans and records.  Facility planning should include multidisciplinary teams to review and recommed work flow, floor plans, equipment necessary, and other related issues before physical implementation of the plans begins.  
Facility layouts should support efficient/effictive patient care sequences with minimal traveling and handling.  
Guidance/example(s):
The organization should determine if design and development apply.  If not, the justification should be documented to assure the customer/ patient/client understands.  When the design and development element is appropriate, there should be precedures about how design is oe be reviewed and approved prior to implementation.  Records of design reviews, verification, and validation should be available.  
The organization plans should address the following:
1. Safety - Buildings, grounds, equipment and support systems should not pose a hazard to employees, patient/clients, or visitors,
2. Security - Property, patient/clients, visitors and data should be protected from harm or loss, including disasers,
3. Hazardous Materials - Handling, storage, transportation, and use of radioactive or other hazardous materials should be managed for safety and proper disposal.  4. Emergencies - Responsibility and authority is defined for all persons involved in emergency activities due to disasters.
5. Fire Safety - Property, employees, patient/clients and visitors should be protected from fire and smoke.  Routine drills are held to assure proper response.  
6. Medical Equipment - Equipment should be selected, maintained, calibrated, and used such that it reduces risks and improves patient/client safety.  
7. Utility Systems - Elecrical, water, telephone, sewer and other utlities should be maintained such that they are capable to respond to disasters or there is a back-up plan to assure patient/client safety.  



航太產業：
AS 9100
7.3.2 設計與發展輸入 (Design and development inputs)
Inputs relating product requirements shall be determined and records maintained.  These inputs shall include:
a) 功能與性能要求 (functional and performance requirements)，
b) 適用的法令與規章要求 (applicable statutory and regulatory requirements)，
c) 適用時，根據先前類似設計推導得到的資訊 (where applicable, information derived from previous similar designs)，以及
d) 其他重要的設計與發展要求 (other requirements essential for design and development)。
這些要求必須經過審查確認它們的足夠性，要求必須是完整、清楚、且彼此之間不會互相衝突。(These inputs shall be reviewed for adequacy.  Requirements shall be complete, unambiguous and not in conflict with each other. )