Lot Number Assignment for Incoming Purchased Products and Customer Supplied Material

al40

Quite Involved in Discussions
#1
Hey Covers,

What is the best way to assign lot numbers to incoming products purchased and customer supplied material? I've seen it done various ways and was wondering if there was an industry standard?

Thanks,

Al
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Trusted Information Resource
#2
Re: Lot Number Assignment for Incoming Purchased Products and Customer Supplied Mater

Hey Covers,

What is the best way to assign lot numbers to incoming products purchased and customer supplied material? I've seen it done various ways and was wondering if there was an industry standard?

Thanks,

Al
In companies that I have worked for we used one of two ways:

Month day year: 10182006

Cage Code (Government issued): (Cage Code)033391006(Month/Year)

But it is best to see what would work for your company.
 

CarolX

Trusted Information Resource
#3
Re: Lot Number Assignment

The best system I have seen assigns the receving ticket as the lot number - this ties right into the purchasing system. I used this system about 20 years ago and it was awsome! We even modified the receving ticket to serve as an incoming inspection record.
 
Thread starter Similar threads Forum Replies Date
M Material Heat Number / Lot Number ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
S Requirements relating to Serial Number and Lot Number Other US Medical Device Regulations 6
M Component Lot Number Traceability - Class I reusable and "resposable" Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 10
R Why the FDA requests Lot Number in Testing Reports 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
V FDA regulatory requirement on the lot number convention for medical devices US Food and Drug Administration (FDA) 2
K Can I use ANSI/AQL for the Total Number of Containers for the entire Lot? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Pipet tips of the same Lot Number have different expiration dates Quality Manager and Management Related Issues 6
C Statistics equation to determine the number of samples in a lot Statistical Analysis Tools, Techniques and SPC 8
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
P New Part Traceability - Lot number and finished product traceability ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Design of Lot Acceptance Sampling Plan - Zero Acceptance Number Sampling Plans Inspection, Prints (Drawings), Testing, Sampling and Related Topics 27
B Validation of FEA Analyses in Oil&Gas Industries. There are a lot of guidelines for other activities. There is a similar proposal for O&G? Design and Development of Products and Processes 0
H A better Lot/bin system Preventive Action and Continuous Improvement 2
T Lot Release Test and Certificate of Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M ISO 13485: 2016 Lot numbering question ISO 13485:2016 - Medical Device Quality Management Systems 4
shimonv Frequency and sample size for lot release of EtO sterilized products EU Medical Device Regulations 2
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
D Supplied Product on Control Plan - Lot ranging in 40,000 pcs per product FMEA and Control Plans 3
K FDA Lot Code format requirements Other Medical Device and Orthopedic Related Topics 1
R Documenting Expiration Date Extension for a specific lot ISO 13485:2016 - Medical Device Quality Management Systems 12
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
N AS9100 8.5.1 j) - Lot splitting - any loopholes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
I Lot or Batch definition for IVDs Imported Legacy Blogs 0
N IVD Lot Numbers and Expiration Dates - 21 CFR 809.10 Other US Medical Device Regulations 3
J PMA Device - Lot # change in New ERP Software - What are the FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
V 'Representative' Sample of the Lot for a Continuous Process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Change in Lot Release Specifications - Definition of "Substantial Change" EU Medical Device Regulations 14
M Lot Numbers of Plastic Disposables in an LDT (laboratory developed test) ISO 13485:2016 - Medical Device Quality Management Systems 6
M How to Mathemetically Derive the AQL Tables given Lot Sizes AQL - Acceptable Quality Level 8
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
U AQL, Lot Size vs Sampling Plans AQL - Acceptable Quality Level 8
Sam Lazzara Lot Release Testing versus Process Validation Studies Qualification and Validation (including 21 CFR Part 11) 9
H How to calculate the Lot Reject Rate Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A How can a sample can give information about bad products in whole lot? Quality Manager and Management Related Issues 3
L Regulatory Submittal During 3 Lot Sterilization Validation EU Medical Device Regulations 3
P Lot Acceptance Plan that specifies BS 6001 Double Sampling Plans, general inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
N Switch to 100% inspection when lot fails sampling? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
G Calculating the Fraction Defective Confidence Interval for a Lot Statistical Analysis Tools, Techniques and SPC 2
S Samples for a Destructive Test included in a Lot Size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
E How to determine the Lot Size for the OQ Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
Ronen E Matrixx Initiatives Recalls One Lot of Zicam? Extreme Congestion Relief Other Medical Device and Orthopedic Related Topics 0
C Changing the Sample Size of a Lot Statistical Analysis Tools, Techniques and SPC 8
J Expanding the c = 0 Small Lot Squeglia Table Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
R Sampling Plan for Wafer Inspection (Small Lot) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4

Similar threads

Top Bottom