SBS - The best value in QMS software

General Production Procedure - Does anyone have a sample? Clause 7.5.1

Stijloor

Stijloor

Staff member
Super Moderator
#11
#11
Re: 7.5.1 Production Procedure-Does anyone have a sample?

pammesue said:
So this is what our quality manual says on the subject.




Production and Service Provision (Service Provision N/A):

7.5.1 Control of Production:

Planning considers, as applicable,

a. The establishment of process controls and development of control plans where key characteristics have been identified,
b. The identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of realization,
c. The designs, manufacture, and use of appropriate tooling and gauging for manufacturing and acceptance.
d. Special processes.

XXXXX plans and carries out production under controlled conditions. Controlled conditions include, as applicable:

a. The availability of information that describes the characteristics of the product.
b. The availability of work instructions, as necessary.
c. The use of suitable equipment.
d. The availability and use of monitoring and measuring devices.
e. The implementation of monitoring and measurement.
f. The implementation of release, delivery and post-delivery activities

7.5.1.1 Control of Service Operations: (N/A)
Click to expand...
Pammy,

You're OK. Trust me...:)

Stijloor.
 
Elsmar Forum Sponsor
P

pammesue

#12
#12
Re: 7.5.1 Production Procedure-Does anyone have a sample?

Well Good...thanks so much for your input. I was about to panic and make myself alot of work lol.

pammy
 
Stijloor

Stijloor

Staff member
Super Moderator
#13
#13
Re: 7.5.1 Production Procedure-Does anyone have a sample?

pammesue said:
Well Good...thanks so much for your input. I was about to panic and make myself alot of work lol.

pammy
Click to expand...
No problem! We're here to help and save people time and effort.

Please do come back to ask questions and help others.

Stijloor.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Production Operators Performing GP12 (General Motors Containment) Customer and Company Specific Requirements 2
A Flowcharts in General and Flowcharts for 7.5.1 Production and Shipping Process Maps, Process Mapping and Turtle Diagrams 9
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
D Preventive Maintenance vs. General Cleaning ISO 13485:2016 - Medical Device Quality Management Systems 2
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
F General Data Protection Regulation (GDRP) CE Marking (Conformité Européene) / CB Scheme 6
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Importing a general wellness low risk product Other US Medical Device Regulations 3
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
G Problem Resolution Report Monitoring - Customer complaint or PRR as general motors use Customer Complaints 12
P Is there a counterpart to the General Safety and Performance Regulations for the USA? Other US Medical Device Regulations 2
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
M Informational WHO – Report by the Director-General – Standardization of medical devices nomenclature Medical Device and FDA Regulations and Standards News 0
J General Motors SSE Launch Algorithm - SCMS's Service Industry Specific Topics 0
D Incoming (Receiving) Inspection - General form for incoming part inspection Document Control Systems, Procedures, Forms and Templates 17
M Informational 2019 Meeting Materials of the General and Plastic Surgery Devices Panel Medical Device and FDA Regulations and Standards News 0
M FDA Guidance - general wellness products - wearables Other Medical Device Related Standards 3
MrTetris GDPR - General Data Protection Regulation - Only applicable to EU data? Other ISO and International Standards and European Regulations 6
M Informational The USFDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019 Medical Device and FDA Regulations and Standards News 0
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Marc Definition GSPR - General Safety and Performance Requirements Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M Annex I - General Safety and Performance Requirements. Precise identity - how provided EU Medical Device Regulations 6
E What is the general time line to prepare for IATF Letter of Conformance? IATF 16949 - Automotive Quality Systems Standard 1
S General Awareness Training for AS9100 Rev.D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B IVD or a general product test kit (if such a thing exists) EU Medical Device Regulations 0
L GDPR scope - "Personal data" definition - General Data Protection Regulation EU Medical Device Regulations 5
S GDPR (General Data Protection Regulation) - My company is ISMS certified IEC 27001 - Information Security Management Systems (ISMS) 3
S Business development and support - Getting business general liability insurance Career and Occupation Discussions 5
DietCokeofEvil What is the general consensus on Caliper tolerances? General Measurement Device and Calibration Topics 1
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 14
Y Change Control - General Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D General questions about Medical Device MOPs and MOPPs IEC 60601 - Medical Electrical Equipment Safety Standards Series 31
Albert G. What are general examples of audit findings with ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H ISO 9001:2015 Cl. 9.3.1 - General Director doesn't participate in Management Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T GDPR - General Data Protection Regulation (EU and UK 2018) Other ISO and International Standards and European Regulations 7
S AS9100D Transitional Audit General Question Checklist AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Dates on Labels acceptable to the USA - GS1 General Specification 3.4.4 Other US Medical Device Regulations 3
K Thoughts on the impact of the General Data Protection Regulation? Medical Information Technology, Medical Software and Health Informatics 5
Pmarszal Clarification for 21 CFR Part 11.100 - General Requirements Other US Medical Device Regulations 14
T Difference betwee General vs. Follow-up Inspections US Food and Drug Administration (FDA) 3
L Wrist Actigraph Device - IEC 60601-1 general questions IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C When is a device considered "sold to the general public?" Canada Medical Device Regulations 2
C Iran - Who is holder of an Iranian registration in general? Other Medical Device Regulations World-Wide 2
V General Full Factorial - Optimal Design Six Sigma 2
R General ISO/TS16949:2009 Implementation Primer Needed IATF 16949 - Automotive Quality Systems Standard 2
W DIN ISO 1101 - Show me the General Dimensioning Tolerance Value Other ISO and International Standards and European Regulations 3
Marc General Motors - 3D Scanning the Competition World News 2

Similar threads

Top Bottom