Meeting AS9100 Clause 6.3 Infrastructure Requirements - Preventive Maintenance

E

Eloy Gomez

#1
b) the requirement is that the organization shall determine, provide and maintain process equipment and (c) supporting services.

We have a preventitive maintenance program in place, some of the items covered in this program are for example: freezers, compressors, grind booths, ovens, CNC machines, table saws, etc...and depending on the type of equipment it depends the extend of the preventitive maintenanced applied and how often.

There are a number of other equipment used to fabricate product not under the umbrella of this program and it gets no daily, weekly or monthly maintenance until it breaks down.

Aside from factors from equipment that may affect product conformity due to temperature, humidity, cleanlinees, etc... what other factors should we look for in determining if this other equipment should also be part of the preventative maintenance program?
 
Elsmar Forum Sponsor
#2
Re: AS9100 6.3 Infrastructure

Hello,
Most important factor to decide the need of preventive maintenanace requirements is probability of failure/break down and related probability of it's effect on production process.

Sure, my friends will come out with more points.
 
A

amariepsu

#3
Re: AS9100 6.3 Infrastructure

We have a pretty good PM program. Most of the information comes from the machine's manual, which usually has a section designated for PM. Anything you feel is appropriate can be added to your schedule as well. We have the schedules attached to a clipboard, and then a calendar where the machinist, or maintenance personnel, signs off after completing the scheduled PM. See attachment for an example. The PM schedule is on the first tab of the spreadsheet.
 

Attachments

Last edited by a moderator:
T

trainerbob

#4
Re: AS9100 6.3 Infrastructure

Even without a specific requirement for preventative maintenance it only makes good sense to look at it. What the standard does require is that we be able to produce a quality product on time. If you have equipment that is involved in producing a quality product on time then logically and reasonably you would want to make sure that equipment continues to function properly so you can continue to satisfy your customers.

One of the best ways to keep our equipment up is to have a good preventative maintenance program. As to what equipment - look at what you need to satisfy your customer and go from there. I try to maintain a good preventative maintenance program on all equipment when possible. If I need it, I need it to run right.
 
#5
Re: AS9100 6.3 Infrastructure

Hi,
I would like to mention that you may consder some measurement mechanism to know how effective is your PM process is .There are many measurement criteria from simple one to many complex.Select appropriate one and unless you are able to measure your process performance,you are not sure whether it is effective.

"What you cannot measure that you cannot improve".:cool:

Try yourself to determine the measurement criteria for your maintenance process.If you face difficulty,your friends are here.
 

howste

Thaumaturge
Super Moderator
#6
Re: AS9100 6.3 Infrastructure

Another relevant requirement in AS9100 has been completely overlooked in the discussion here - clause 7.5.1.3. I don't think you mentioned if you were working to Rev B or Rev C of AS9100, so I'll quote both here:
AS9100 Rev B said:
7.5.1.3 Control of Production Equipment, Tools and Numerical Control (NC) Machine Programs:
Production equipment, tools and programs shall be validated prior to use and maintained and inspected periodically according to documented procedures.
AS9100 Rev C said:
7.5.1.3 Control of Production Equipment, Tools and Software Programs
Production equipment, tools and software programs used to automate and control/monitor product realization processes, shall be validated prior to release for production and shall be maintained.
The revision B requirements are more prescriptive in requiring both periodic maintenance and documented procedures. To me this says that we must establish a periodic frequency for maintaining process equipment, and just waiting until it breaks down does not meet the requirement.

The revision C requirements only state that process equipment must "be maintained." In this case there is no periodic requirement.
 
T

trainerbob

#7
As these standards evolve over time we are beginning to see that the Quality Management Systems are showing their value as Business Management Systems - the way it makes sense to do business. Each rewrite of a standard gets us closer and closer to the way we should operate to improve the bottom line of our business.
 
Thread starter Similar threads Forum Replies Date
T Meeting AS9100 Clause 7.4.3 e) Delegation of Verification requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 18
I Meeting AS9100, FAA, Transport Canada, EASA Training Requirements - Vent/Rant Coffee Break and Water Cooler Discussions 2
N Meeting AS9100 Rev C Requirements - Major help wanted AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 27
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
T Management review meeting workflow ISO 13485:2016 - Medical Device Quality Management Systems 9
M Informational EU – Minutes of the 24 July 2019 SCHEER Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) meeting Medical Device and FDA Regulations and Standards News 0
M Informational EU – Meeting minutes – Competent Authorities on Substances of Human Origin Expert Group Medical Device and FDA Regulations and Standards News 0
J Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting ISO 13485:2016 - Medical Device Quality Management Systems 13
M Informational EU – 12th Meeting of the Working Group on Guidelines on benefit – risk assessment of Phthalates in Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019 Medical Device and FDA Regulations and Standards News 2
M Informational 2019 Meeting Materials of the General and Plastic Surgery Devices Panel Medical Device and FDA Regulations and Standards News 0
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
M Informational EU – SCHEER – Minutes of the Working Group meeting on guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devic Medical Device and FDA Regulations and Standards News 1
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0
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 Medical Device News USFSA – 2019 Meeting Materials of the Obstetrics and Gynecology Devices Panel Medical Device and FDA Regulations and Standards News 0
M Informational ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 6
M Medical Device News ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 0
D FDA Pre-Submission Meeting Advice US Food and Drug Administration (FDA) 0
M Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Medical Device and FDA Regulations and Standards News 0
M FDA News FDA announces panel meeting on surgical mesh placed transvaginally to treat pelvic organ prolapse Medical Device and FDA Regulations and Standards News 0
L 510 (K) Pre-Sub meeting - Does it worth? US Food and Drug Administration (FDA) 4
Q ISO planning annual meeting? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T FDA Q-Submission Informational Meeting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Marc IAQG Cleveland, Ohio Meeting - October 16-19, 2017 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
K Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
B IATF 16949 Cl. 4.3.2 - Meeting Customer Specific Requirements IATF 16949 - Automotive Quality Systems Standard 13
Z MRM (Management Review Meeting) Template for ISO 9001:2015 Management Review Meetings and related Processes 3
S Corporate Quality Manager keeping me out of the Management Review Meeting Management Review Meetings and related Processes 28
F Development Meeting with the FDA - Approval Pathway for a Combination Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M ISO 14971:2007 Revision Approved - The Delft ISO TC 210 plenary meeting - Nov 2016 ISO 14971 - Medical Device Risk Management 2
L Auditing Top Management - Meeting Competency Requirements and Questions to Ask General Auditing Discussions 11
J Organizational Knowledge Requirements - Meeting ISO 9001:2015 Clause 7.1.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 60
D What should be included in Management Review Meeting for ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q REACH due dilligence and meeting the ever moving SVHC target RoHS, REACH, ELV, IMDS and Restricted Substances 5
N Incompleted tasks from previous management review meeting Management Review Meetings and related Processes 1
B Meeting the requirements of ISO/TS16949 Clause 6.2.2.3 IATF 16949 - Automotive Quality Systems Standard 4
L CB finding on Management Review Meeting Management Review Meetings and related Processes 32
J Meeting Feasibility Requirement - High number of part quotes IATF 16949 - Automotive Quality Systems Standard 6
M Presentation Material for New Project Kick Off Meeting Manufacturing and Related Processes 2
D Documenting Meetings through Meeting Minutes or a Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Consult "GM APQP" Step1: Key Stakeholders Meeting - GM 1927-18 APQP and PPAP 5
T Question re: Meeting the Requirements of ISO 9001 Clause 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Management Review Meeting Agenda and Minutes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Hershal IAS Public Accreditation Committee Meeting Feb 10, 2014 General Measurement Device and Calibration Topics 2
R Aerospace QPL Suppliers not meeting our AVL requirements. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
D Integrated 9001, 14001, 18001 Management Review Meeting and Minutes Management Review Meetings and related Processes 10
I Content to be included or excluded in Design Control Meeting Minutes ISO 13485:2016 - Medical Device Quality Management Systems 4
drgnrider Corrective Action for not meeting target-RCA obvious ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Similar threads


















































Top Bottom