Para 4.9.d.1 Special Characteristics

K

kevin

#1
#1
I am currently implementing QS in an electronics company which is third / forth tier i.e we are not directly supplying any of the big three. We have no customers identifying charateristics of our product as "Special". It is my intention to define several product paramters as "Key". These are the ones which our main quality improvement activity is being focused (and the main parameters which are important to our customers.
Does this meet this requirement. Thanks in advance for your comments.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
A

Al Dyer

#2
#2
Kevin,

I see no problem with your course if you define the "Key" parameters/characteristics within your control plan.

ASD...

------------------
Al Dyer
Mngt. Rep.
JAE Tech Inc.
[email protected]
 
I

[email protected]

#3
#3
You're action is accptable. The requirement is for you to identify Key or Special Characteristics during quality planning. It does not matter what you call them, so long as you can show how they're controlled.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K D&D for AS9110 - Para 7.1.5 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Informational ANVISA – CONSULTA PÚBLICA Nº 734, DE 22 DE OUTUBRO DE 2019 – Registro de dispositivos médicos para diagnóstico in vitro (in vitro diagnostic medical m Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – Aberta inscrição para evento sobre dispositivos médicos (ANVISA medical devices day event) Medical Device and FDA Regulations and Standards News 0
M Informational Feira Hospitalar – Programação da X Jornada de Ação em Política Industrial e Regulação para Produtos da Saúde (Portuguese only) Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – INSTRUÇÃO NORMATIVA N° 32, DE 12 DE ABRIL DE 2019 – Delegação da inspeção para verificação das Boas Práticas de Fabricação – Delegation of in Medical Device and FDA Regulations and Standards News 0
M Informational EMA – Guidelines for certain medical devices incorporating medicinal products – Orientações para certos medical devices que incorporam medicamentos Medical Device and FDA Regulations and Standards News 0
M Medical Device News ANVISA – Consulta Pública nº 586 de 20/12/2018 – Diretrizes de Garantia da Qualidade para Validação, Monitoramento e Controle de Rotina dos Processos Medical Device and FDA Regulations and Standards News 0
M Medical Device News ANVISA – Consulta Pública nº 585 de 20/12/2018 – Boas Práticas para o Processamento de Produtos utilizados na assistência à saúde Medical Device and FDA Regulations and Standards News 0
L ISO 17025 Para. 5.4.5 - Method (Calibration Procedure) Validation Requirements ISO 17025 related Discussions 2
R Para 4.2.2 b) Referenced Documents - Adequate referencing? Copy and Paste? ISO 13485:2016 - Medical Device Quality Management Systems 5
R Relating Cpk to Sampling Plans - AS9100C Para 8.2.4 & AS9103 Para 4.4 d. Capability, Accuracy and Stability - Processes, Machines, etc. 1
S AC7101-3 - What is the intent of Para 9.0? Temperature Measurement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
S NADCAP AC7114 rev E (audits after June 12, 2011) Para 4.4.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T ISO 13485:2003 Health requirements per para 6.4a ISO 13485:2016 - Medical Device Quality Management Systems 2
S AMS2750 rev D - para 3.2.6.2 - "Signature of the calibration company representative" Various Other Specifications, Standards, and related Requirements 3
B AS9100 & Safety Audit Findings - Para 6.4 Work Environment - Fork lift records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Coury Ferguson Customer Satisfaction - Objective Evidence AS9100, para. 5.2, 7.2.2, 7.2.3, 8.2.1 Records and Data - Quality, Legal and Other Evidence 3
H What is 'Direct Run First Time Quality Result' - IATF Guide, Para 7.4.3.2? IATF 16949 - Automotive Quality Systems Standard 6
R Salaried Employee Training requirements in ISO9001 para 6.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Minimum retention or the date of destruction of a record - ISO 9001-2000 Para. 4.2.4 Records and Data - Quality, Legal and Other Evidence 13
B Measurement Uncertainty (MU) vs. Level of Certainty - ISO17025 para. 5.1.1 ISO 17025 related Discussions 8
M APQP & C/P Manual, Pg33, Para 3 - Control Plans - Clarification please FMEA and Control Plans 5
Sidney Vianna Para nuestros amigos de Mexico - RABQSA in Mexico City ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
J 17025 Para. 5.6.2 - Calibration certificates - Measurement results - Uncertainty ISO 17025 related Discussions 6
J Recommendations on calibration interval (frequency) ISO/IEC 17025:2005 para 5.10.4.4 ISO 17025 related Discussions 5
S Internal laboratory requirements and technician skills - TS 16949 para. 7.6.3.1 General Measurement Device and Calibration Topics 1
A Validation of Processes - How to meet requirement of TS 16949 para. 7.5.2.1? IATF 16949 - Automotive Quality Systems Standard 12
F What do suppliers define as Documents of external origin? TS16949 Para 4.2.3 f) Records and Data - Quality, Legal and Other Evidence 2
R Description of the Interaction of Processes - Para 4.2.2 c) - Seeking Examples ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
T TS 16949 Para. 7.6.3.1 - Internal Laboratory - Defined scope that includes capability IATF 16949 - Automotive Quality Systems Standard 11
D AS9100 Para 7.5.1.3 Maintained according to documented procedures... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
K Business Plan - Quality Objectives and Measureables - TS 16949 Para 5.4.4 IATF 16949 - Automotive Quality Systems Standard 8
V TS 16949 - Para. 8.2.2.1 QMS Audit - How are you meeting this requirement? General Auditing Discussions 14
M Contract Personnel On the Job (OJT) Training - TS 16949 Para. 6.2.2.3 IATF 16949 - Automotive Quality Systems Standard 8
I How can I provide evidence of On-the-job training (OJT)? TS 16949 Para. 6.2.2.3 IATF 16949 - Automotive Quality Systems Standard 13
P QS para 4.6.2.1 and SI para C9: D1-9000 and AS-9100 NOT acceptable? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
G Control total de calidad para Hospitales Hospitals, Clinics & other Health Care Providers 1
T Scope of Registration - Refer to the QSR appendix I para 19 QS-9000 - American Automotive Manufacturers Standard 1
J Qs-9000 para. 4.18 QS-9000 - American Automotive Manufacturers Standard 1
M Para 4.6.3c - What is meant by the last part; ...number and issue of...? QS-9000 - American Automotive Manufacturers Standard 4
Marc AS9000 para 4.10.2.4 - Certification Test Reports for Product Acceptance Various Other Specifications, Standards, and related Requirements 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Special Controls and Standards Other US Medical Device Regulations 0
A Special Characteristic question from Automotive CSR Customer and Company Specific Requirements 9
N Validation of special processes - thread closed Oil and Gas Industry Standards and Regulations 3
John C. Abnet Special Status Notification IATF 16949 - Automotive Quality Systems Standard 1
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 18
A IRIS audit - Discussion about Special Processes General Auditing Discussions 11
S SOP Identification of Special Characteristics IATF 16949 - Automotive Quality Systems Standard 6
B AS9102 - 3D printing a special tool required for assembly (counterfeit risk?) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
Nihls MSA Study Type 2 (special conditions ) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0

Similar threads

Top Bottom