Control of Sterile Barriers made by the supplier

#1
Hello together. Hope all is well. I would like to get advice from you regarding what we have faced as an issue in a close time manner.

Normally, when a sterile pouch is changed with a new one in a product portfolio, first of all, CRS(Component requirement specification) is created to specify the material requirements. And then the initial sampling tests are performed. (Dimensional measurement, supplier seal seam check, etc.) When initial sampling is completed, the process validation is performed in order to specify the internal sealing parameters. The supplier seal, as well as the internal sealed seam, is tested in the scope of the design verification test. There is also QA/RA agreement that the supplier is qualified and also seals are validated according to ISO 11607-2. Therefore when the pouch is purchased and gets to the facility, only Receiving inspection is control the supplier seal according to the AQL level. There is no control point in the production in terms of seal width for the supplier seam. There is only checkpoint regarding internal sealed seams. But we had an issue that some pouches (tyvel reel) did not meet the requirement and it is noticed in the production. (Some seals were almost 4mm; normally it has to be greater than 6 mm.). Now, our quality department request checkpoint to the supplier seams.

How do you feel regarding this situation? Do we have to add checkpoints to the supplier seams even though our QA/RA agreement? (Supplier has to ensure that seal seams are higher than 6mm.). It does not make sense to me to add control points to the supplier seam in production. Maybe Receiving inspection department could increase the sample size but not for the production site. We have already lots of checkpoints and control forms.

Do you have any recommendations on how to solve the issue properly ?

Thanks in advance.
 
Elsmar Forum Sponsor
#2
From my perspective, you do not need to add any control point in the production steps if you have an agreement with the supplier regarding ISO 11607-2. The supplier must be produced sterile bags according to your specifications and regulations. But to avoid the issue in production, you can add additional control points in the receiving inspection side i.e increase the AQL level or add the control point for the supplier seam.
 

chris1price

Trusted Information Resource
#3
As you say, this is a problem with the supplier, not with production. I would discuss it with the supplier first. You say it is checked on receipt according to an AQL, You should review the AQL to ensure it is appropriate now you know there is a potential issue and also look at the sampling regime to ensure it is random across the batch.
 
#4
Thank you guys for your recommendations. As a consequence, I will regret adding control points to the production site in regards to supplier seam if Quality department insists on this idea. I will reach out the supplier and make sure their process is stable and well controlled. And increase the AQL level (so increase the sample size) for the RI. Any further recommendations are appreciated :)
 
Thread starter Similar threads Forum Replies Date
S Environmental Control Standards - Sterile medical device manufacturing environment ISO 13485:2016 - Medical Device Quality Management Systems 3
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
V Opinion on gauge control graphic General Measurement Device and Calibration Topics 5
S ISO 14001 Operational Planning and Control - Proving evidence of communicating environmental requirements to suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V How to control odour outside paintshop ISO 14001:2015 Specific Discussions 1
G FMEA versus control plan IATF 16949 - Automotive Quality Systems Standard 6
K ISO 2859-5 (single run production) control plan issues FMEA and Control Plans 2
E Control Charts ISO 17025 related Discussions 7
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
M X-MR Control Chart Rules (Particularly the MR) Statistical Analysis Tools, Techniques and SPC 3
I Clinical study suppliers (service providers) -- extent of control ISO 13485:2016 - Medical Device Quality Management Systems 4
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
T Control Excel template Document Control Systems, Procedures, Forms and Templates 5
J Document Control of Online Management Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R 8.7 Control of Nonconforming Outputs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
W Document control Document Control Systems, Procedures, Forms and Templates 10
S Control plan - Multiple batches Manufacturing and Related Processes 2
Q Control Plan and the frequency of sampling FMEA and Control Plans 11
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
qualprod Sheets into a spreadsheet document control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Rene Minassian Control of (TMME) Testing and Measurement Equipment Oil and Gas Industry Standards and Regulations 2
C Control Plan APQP and PPAP 7
D Control of Records ISO 13485:2016 - Medical Device Quality Management Systems 7
M Document Control - Applying Suitable Identification to Obsolete Documents ISO 13485:2016 - Medical Device Quality Management Systems 5
L Control of Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
S Control plan for "highly automated processes" FMEA and Control Plans 3
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 6
R SCORING OF MILLER MARITAL LOCUS OF CONTROL SCALE Coffee Break and Water Cooler Discussions 2
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
D 8.5.1.2 Validation and control of special processes requirements for Heat Treat External Processor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Humane Pest Control Food Safety - ISO 22000, HACCP (21 CFR 120) 1
B 8.5.1.1 Control Plan - question audit NC IATF 16949 - Automotive Quality Systems Standard 5
B QM Plan vs Control Plan IATF 16949 - Automotive Quality Systems Standard 3
N AS 13004 Control Plan and AQL FMEA and Control Plans 1
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
qualprod Traceability with no rules to control labels? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Doubt about the correct control chart Statistical Analysis Tools, Techniques and SPC 14
G Change Control for Test Samples Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Z Change color or shape of individual data point in control chart Using Minitab Software 6
Z Setting the Control limits on Minitab Using Minitab Software 4
C Elaborating a control chart with skewed data Manufacturing and Related Processes 4
M Who is performing quality control? IATF 16949 - Automotive Quality Systems Standard 2
S Risk control through Information for safety ISO 14971 - Medical Device Risk Management 12
D Locking Control Limits and SPC Sample Sizes (AIAG/Automotive Requirements) Six Sigma 2
Q Control limits Six Sigma 6
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
T Control of Nonconforming Material AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
G Control of Approved Supplier List (ASL) When Employees Make Purchases Supplier Quality Assurance and other Supplier Issues 6
dpenbert AS9100 7.5.3 - Manual Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6

Similar threads

Top Bottom