Lenght of time that the product is "active" - 4.16.1 - Life of product + 1 year

M

Michel Saad

#1
Hi folks,

Can anyone give me a definintion of "lenght of time that the product is active" as stated in 4.16.1

We are having disagreements internally on this point. Where I worked before, it was stated as "duration of the contract + 1 year", but I am not sure that it meets the intent.

Let me know how you deal with this.

Michel
 
Elsmar Forum Sponsor
#2
That is normally a requirement established by your customer; includes production and service requirements. Service requirements can be as long as 10 years.
 
#3
That is normally a requirement established by your customer; includes production and service requirements. Service requirements can be as long as 10 years.
 
M

Michel Saad

#4
Bonjour Lyman,

When you say that the product is active in your portfolio, do you include or exclude revisions. What I mean by that is if the part changed from XXXX rev A to XXXX rev B, do you keep the info of A for 1 extra year or do you keep it until the last of the revisions is no longer active (which could be many many years later)?

Thanks in advance

Michel
 
L

lyman

#5
Great question - I admit I hadn't contemplated it when I responded, although after asked I suspected what our position would be given the raging paranoia we have regarding throwing anything away. I went and confirmed my suspicions with one of our Quality Managers - we're going to keep everything (Rev data included) until such time that we are no longer producing the part. My question to you - would you set up your system such that a decision to destroy the records is based on the type of revision being made, i.e., if your changing your labels or labeling info and it requires a revision you're not going to pitch all the prior rev history incorporating your test results, etc., are you?

As you can see - our system will never require us to make those decisions, however, if we ever have a fire you should be able to spot it from Quebec because we'll have plenty of fuel!!
 
M

Michel Saad

#6
Make sure the fire is in winter and we can send you a couple hundred trucks of snow to help put it out!!

We have a 2 revision system. The parts are more like XXX rev A.1. For minor changes, the .1 will move to .2 while for major changes (fit, form, function, reliability), the letter revision will change. We have some parts at F.12 and they have nothing to do with A.1, so I ask why keep the data around? Obviously, we are going to be smart and not throw away material from a previous revision if it is still useful. I am simply looking for a way to not HAVE TO keep material forever if it has no added value. The issue is, does treating a new revision of product like a new product (even though the part number doesn't change) meet the intent of 4.16 of QS9000?

Regards,

Michel
 
L

lyman

#7
I can only speak for myself as an auditor (maybe Marc or someone else can let you know how they would audit to this requirement) but if I audited my engineering/design groups and their system was set up like yours I would expect that they could provide the appropriate new documentation/samples, etc. as required under Sect. III of PPAP. I would also expect that they could show me a Rev history or some linkage between revs. As long as their records reflect their complete current process then if they had documented to destroy prior revision records after the calendar year requirement was met I wouldn't have an issue with that.
 
L

lyman

#8
Bonjour Michel:

The group I formerly worked for, who were QS9K certified in 1998 (and the one that I now work for - who are busy putting our system together for certification in 2001)are writing our retention documents as follows: records will be retained for families of devices or single devices for as long as the device remains active in our portfolio + one calendar year. If you look at the PPAP Manual, Sect. VI (bold printed text specifically, add Sect. 4.16.1.S of the Semiconductor Supplement, in addition to the requirements under Sect. 4.16 of QS9K I think you can understand how we have come to our decision. (QS9K requirements turned out to be one of the great motivators to cull the portfolio at my last job, I'm hoping it will have the same effect here.)

Regards
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Originally posted by lyman:

...we're going to keep everything (Rev data included) until such time that we are no longer producing the part.
I think this is the key.
 
Thread starter Similar threads Forum Replies Date
S Classification of a product according to MDR EU Medical Device Regulations 0
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
A Software bug fixes after shipping a product EU Medical Device Regulations 3
silentmonkey How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
S California Cleaning Product Right to Know Act - Product Label advice needed Miscellaneous Environmental Standards and EMS Related Discussions 1
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
H PCD remains valid for new product ISO 13485:2016 - Medical Device Quality Management Systems 11
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
E How do you determine if hipot is necessary for a cable product? Manufacturing and Related Processes 8
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
N Authorised Representative details on product label? EU Medical Device Regulations 1
D Importing a general wellness low risk product Other US Medical Device Regulations 3
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 1
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 5
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H Remote product audits in Coivd-19 - IATF 16949 9.2.2.4 IATF 16949 - Automotive Quality Systems Standard 3
B EU MDR Perscription product guidance EU Medical Device Regulations 1
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
B Product Safety Responsibility - Job shop such as a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Miner Quality checks of product QR codes FMEA and Control Plans 2
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
G Handling Unpacked (Additive Chemical) Product For Automotive Applications IATF 16949 - Automotive Quality Systems Standard 3
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
T Modification of a product on the market EU Medical Device Regulations 2
D CE Marked product considered a Drug in India Other Medical Device Regulations World-Wide 0
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
S How do you record your Nonconforming product? Batch production of staged processes Nonconformance and Corrective Action 2

Similar threads

Top Bottom