Skip Lot Inspection - What do we look at and when?

A

Andrews

#1
#1
skip lot

We would like to adopt skip lot inspection for one of our better processes.My question is :
What are the things that should be looked into before going in for skip lot ?
and how should we bring this under the quality system?/

please help
 
Paper to QMS ad
Elsmar Forum Sponsor
R

Rockanna

#3
#3
Skip Lot

Hey, we have developed a skip lot program after we started our certified supplier program. We came up with some criteria to audit our suppliers by; rated them; certified them; and after so many lots were accepted by our inspection department put them on our skip lot program.

If there were any rejects discovered in our manufacturing process, this information was feedback to our inspection department. Depending on the kind of reject discovered, we would make a note in an active electronic file and inspect the next lot received from that supplier. In our skip lot process, we may elect to inspect every 3rd or 4th lot that arrives at our facility. This program works but it takes constant monitoring of your supplier's performance.

We remove supplier's from this program if they continually fail to meet our requirements and they can be removed from our certified supplier list if the sufficient corrective action plans have not been effective on their part.
 
V

Vash Stampede

#4
#4
You can skip lot if there's no history of nonconforming for the particular lot. Or if you have a tracking system, where you could easily track problematic lots.



Hope this helps.
Best regards,
Vash :cool:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Standards Australia - AS1199.3 2003 Skip Lot inspection Criteria and Requirements Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
J Incoming Inspection Skip Lot - Industrial staples Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T ISO 2859-3 - Skip-lot sampling procedures - Unauthorized Inspection Frequency Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A C=0 and Skip Lot Sampling Plan Relationship Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
T Skip Lot Sampling Plans (SkSP) - Oil for Trans Fatty Acid Content Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
P Skip Lot for product or for Supplier ? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
J ANSI/ASQ Z1.4-2003 Sampling with Skip Lot Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Sampling - Skip Lot - 20 ppm - What is your opinion of Skip Lot sampling? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Skip-Lot Testing and the FDA - Reduced Testing Plan for Raw Materials Statistical Analysis Tools, Techniques and SPC 8
M Skip Lot Sampling - How to Perform Skip-Lot and Chain Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
J Can I skip Payment Process audit for TS16949 Internal Audit? IATF 16949 - Automotive Quality Systems Standard 4
V Skip Testing for Uniformity of Dosage Units & Dissolution US Food and Drug Administration (FDA) 2
O PPAP Material and Performance Testing - Possible to skip? APQP and PPAP 3
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
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
D Supplied Product on Control Plan - Lot ranging in 40,000 pcs per product FMEA and Control Plans 3
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
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
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
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
S Requirements relating to Serial Number and Lot Number Other US Medical Device Regulations 6
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 5
M Component Lot Number Traceability - Class I reusable and "resposable" Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 10
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
R Why the FDA requests Lot Number in Testing Reports 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
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
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
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
M Pipet tips of the same Lot Number have different expiration dates Quality Manager and Management Related Issues 6
L Regulatory Submittal During 3 Lot Sterilization Validation EU Medical Device Regulations 1
C Statistics equation to determine the number of samples in a lot Statistical Analysis Tools, Techniques and SPC 8
P Lot Acceptance Plan that specifies BS 6001 Double Sampling Plans, general inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
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

Similar threads

Top Bottom