The Need to Update / Revise Work Instructions and Procedures

Randy

Super Moderator
#1
The need to update / revise Work instructions / Procedures

OK boys and girls I'm on the horns of a delima:confused:

Let's surmise (a $2 word here)that we have posted on some small ovens, used to cure circuit boards and the such, emergency work instructions / procedures.

And let's surmise (another 2 bucks here)further, that the personnel who signed these work instructions / procedures no longer work at the establishment.

And we further stipulate (new $2 word) that there have been no changes / revisions required with these work instructions / procedures.

Does anyone see or have an issue with this?
 
Elsmar Forum Sponsor
#2
No problem, as long as they comly with the requirements stated in 4.4.5. There is no requirement to revise the document author when the original author is no longer employed at the company.
 
A

Al Dyer

#3
Randy,

Not knowing the specific structure of your documentation process I will say this:

Work instructions (level III) do not require a signature on the instruction itself. Only that it be approved and current. There are situations where due to turnover or multiple operators the situation can be covered through a training log.

Any employee operating a new machine should be trained in the work instruction with training records held by HR (or whomever).

This way when an auditor askes someone if they have been trained to perform the operation, the employee can say sure, HR has my training records.

Now if the operator is not following the instruction, Well that's for another thread.:)
 

SteelMaiden

Super Moderator
Super Moderator
#4
Greetings!

I think as long as the new operators know what they are doing, are doing it as documented, and can find the documents if asked (training and documentation) Sam and Al are probably right on the money.

But, I have a feeling that there is something here that we are not seeing, cuz it looks like a trick question to me.:eek: :biglaugh:
 

Randy

Super Moderator
#5
Kool:)

What you guys have said is along my line of thinking.

What I have is emergency procedures governing actions to take when the ovens get hot, lose power , or some other thing that would effect the quality of the item being treated but presents no environmental or safety hazard. I'm only worried about the impact of these WI's on the 14K program and not the QMS.

These WI's were initially intended to be a "temp measure" only and as we know the "temp" things have a tendency to become entrenched into our way of business.

Thanks:bigwave:
 
E

energy

#6
How u do dat?

Happy Holidays, Jarhead:agree:

How did you make the jump from people no longer there to "Temp" procedures. :bonk: Maybe Steelmaiden was right, there was more to be learned. Like, maybe she's peeked into your "post":biglaugh:

Like "Energy's got a great new bag":vfunny:
 
Thread starter Similar threads Forum Replies Date
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 14
M If I update a DFMEA do I need to submit to my Customer? FMEA and Control Plans 7
B Class IIb Medical Device using Annex II route - Need to Update ISO 13485 Scope? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Work instructions inaccurate - Need to update and improve documentation system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Need tips to update resume Career and Occupation Discussions 15
P Company Acquisition - What do we need to update with our registrar? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Need Service to update External Documents and Specifications Document Control Systems, Procedures, Forms and Templates 3
K Need to update our training format to ISO 13485:2003. Training - Internal, External, Online and Distance Learning 2
V Need to update to ISO 9001:2000, current registered to ISO 9002 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
N do you need to update PPAP due to a discrepancy APQP and PPAP 1
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 0
U Need Help With API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 6
S In Need of GIDEP Guidance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Do employee training records need to be controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D What evidence to I need to supply as a remote location in relation to manufacturing sites? IATF 16949 - Automotive Quality Systems Standard 10
T Non API products need to comply to API Q1? Oil and Gas Industry Standards and Regulations 3
G Need journal and reference of abnormal bar chart SPC Statistical Analysis Tools, Techniques and SPC 4
MSeibert47 Daily Quality Topics - Need Ideas Please! Food Safety - ISO 22000, HACCP (21 CFR 120) 15
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
D Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
A Need to calculate tolerance Intervals with a set of non-normal data and 3-Parameter Weibull distribution Using Minitab Software 0
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 10
F Need Quality Manager advice. Quality Manager and Management Related Issues 6
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Do CTQs need to be equipment specific? FMEA and Control Plans 8
K Contract Manufacturer Do they need a complaint procedure? Medical Device and FDA Regulations and Standards News 8
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
D Do employee training records need to be centralized? IATF 16949 - Automotive Quality Systems Standard 10
H Need of EU Representative Designation for Turkey? EU Medical Device Regulations 3
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
briteme4 AS9102 First Article Inspection - do I need a second reviewer and signer? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 6
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K Interesting Discussion "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2

Similar threads

Top Bottom