Bringing Production in house from Contract Manufacturer

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
Trying to SWAG project scope to bring production in house. Its relatively simple process that requires 5 people to assemble, test and, package each device and could be done in a small conference room. Here is what I have on my list that is a new burden in formerly using a contract manufacturer:
  • Add production to our ISO scope/FDA
  • Set aside dedicated area for production control
  • Add tools/equipment to calibration/maintenance schedule
  • Regulated receiving area
  • Receiving inspection methods developed
  • NC segregation area for pre and post production
  • Secure the inventory of raw materials
  • Dedicated/Isolated production area with cleanliness requirements
  • Build process to create work packets and picking parts
  • Detailed production instructions
  • Regulation of production tools and jigs
  • Production data management and control
  • New training requirements
  • Safety review and training
  • Contamination/env controls including PPE, etc.
  • Secure the inventory post production
  • Shipping and logistics processes created with contract warehouse/shipper
  • We do 100% verification of all devices so no production validation required.
What else should be on this list?
 
Elsmar Forum Sponsor

TheMightyWife

Involved In Discussions
#2
To be honest it's quite complex question. What have you got already in place in terms of quality system?
Have you got all procedures required by ISO standard? Full Technical Files in place?
There is a number of tasks that need to be addressed if you are manufacturing yourself, some of them are:
- Calibration of equipment, traceability, agreements with suppliers, controlled work instructions, forms etc...
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
CE mark, ISO 13485:2016 (exc Production and service provisions) Full Tech File. We have a complete 13485 system in place for everything but prod


1.1.1 The following clauses are not applicable:

1.1.1.1 The requirements for installation (21 CFR 820.170, ISO 13845:2012 Section 7.5.1.2.2, ISO 13485:2016 Section 7.5.3) and servicing (21 CFR 820.200, ISO 13485:2012 Section 7.5.1.2.3, ISO 13485:2016 Section 7.5.4) do not apply since these operations are not performed by

1.1.1.2 Sterilization does not apply to any of the facilities since does not produce any sterile products (ISO 13485:2012, section 7.5.1.3, 7.5.2.2, ISO 13485:2016, section 7.5.5 and 7.5.7).

1.1.1.3 The requirements for implantable medical devices (ISO 13485:2012, section 7.5.3.2.2 and 8.2.4.2, ISO 13485:2016, section 7.5.9.2 and implantable specific requirements in clause 8.2.6.


Name omitted
 
Last edited:

TheMightyWife

Involved In Discussions
#4
Admin, I pasted article below, if not allowed, please remove and keep the link.
Interesting article (all the points are raised):
https://advisera.com/13485academy/b...n-and-service-provision-process-in-iso-13485/
Control of production and service provision
Sub clause 7.5.1 contains general requirements for the production and service provision process. It requires the organization to plan, carry out, monitor and control the production and service provision process in order to ensure a product that conforms to specification. Control of the production process is a key for manufacturing a product that is compliant with the specification, and this can be achieved through:

  • Documentation of procedures and methods for the production control – Depending on the complexity of the production process, the organization needs to decide on the necessary amount of documentation to ensure the product conformity. (as I mentioned, controlled Standard Operating Procedures, Work Instructions, Forms: Goods In, actual method of manufacturing, shipping, customer services etc)
  • Qualification of infrastructure – In cases where the infrastructure used in the production process can affect the conformity of the product, the organization needs to define requirements for infrastructure and ensure the production process is carried out as planned.
  • Implementation of monitoring and measuring process parameters and product characteristics – Depending on the nature of the production process, the organization needs to implement monitoring and measuring activities to ensure the production process is carried out as planned and the product is compliant to the specification (sign off sheets for First Off, Last off? Retention policy e.g. 12 months, verification during manufacture).
  • Availability and use of monitoring and measuring equipment – To ensure the credibility of the monitoring and measurement data, the organization needs to provide the monitoring and measuring resources that are fit for the purpose (calibration if required, maintenance documents and their retention).
  • Implementation of defined operations for labelling and packaging – Depending on the type of product, different requirements for labeling and packaging may apply. The organization needs to identify and apply these requirements during the production process (again, procedure and spec, verification that correct labels applied etc).
  • Implementation of product release, delivery and post-delivery activities – Once the product is manufactured, the organization needs to define and perform activities for product release, delivery and post-delivery, if the nature of the product requires it (full traceability from raw material to finish product shipped to customer).
Finally, the clause requires the organization to maintain records for each medical device or lot produced.
Additional requirements for production

Cleanliness of the product. When this requirement is applicable, the organization needs to document requirements for cleanliness and contamination control of the product.

Servicing activities. If servicing activities are required by the customer, the organization needs to document the servicing procedures, reference materials, and reference measurements for performing servicing activities and ensuring the product requirements are met.

Particular requirements for sterile medical devices. If applicable, the organization needs to maintain records on sterilization parameters for each sterilization batch.

Identification and traceability. The organization needs to document the procedure for identification and traceability to identify the product throughout product realization. In the case of implantable medical devices, the traceability should include records of component, materials and conditions for the work environment used, if applicable.

Customer property. When a customer has given you any property to use in supplying their needs, you need to control that property from unintended use. You also must have a way of dealing with that property (with customer involvement) should there be a problem with it. Records of products found unsuitable for use shall be maintained.

Preservation of product. For some products, there is a need to properly handle it throughout the process to make sure it does not degrade. This includes during delivery to the customer. These actions will vary widely depending on the product, but could include such things as reducing moisture exposure on metallic parts that could rust. It can also involve using stock in order of receipt (often called first-in-first-out, or FIFO) for stock that can degrade over time.
 
Thread starter Similar threads Forum Replies Date
Ed Panek Bringing Production In house ISO 13485:2016 - Medical Device Quality Management Systems 10
M Bringing blending in-house - Verification or full validation? (Disinfectants) ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna IATF bringing stakeholders together to ensure Transition by the 2018-09-14 deadline IATF 16949 - Automotive Quality Systems Standard 10
Q Bringing Medical Device Prototypes into the US Other US Medical Device Regulations 3
T AS9104/3 is bringing in a requirement for an AA to qualify as AEA based on Audit Days AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
S Bringing a Medical Device Sample from a Foreign Country into the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Q Gap Analysis - Bringing a smaller subsidiary company up to IS0 9001:2008 standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Bringing a Second Office Location into Registration Scope ISO 14001:2015 Specific Discussions 12
C Bringing a CQA Primer Copy for an exam Professional Certifications and Degrees 14
C Bringing Simple Calibrations Back In-House General Measurement Device and Calibration Topics 16
T QMS in place - How to illustrate? Small matter of bringing it into action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Wes Bucey To sue, or not to sue: That is the question until you are the person bringing suit... Coffee Break and Water Cooler Discussions 73
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
J Production Line Test Brasil - High Voltage Dielectric Strenght Test Other Medical Device Regulations World-Wide 5
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
S How do you record your Nonconforming product? Batch production of staged processes Nonconformance and Corrective Action 2
A When there is a 2 year lapse in production, is a full FAI required? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
P Definition of production tooling in IATF16949 clause 8.5.1.6 IATF 16949 - Automotive Quality Systems Standard 4
Moncia Production Planning procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Pre-Production Capability Assesment Reliability Analysis - Predictions, Testing and Standards 5
N Calibration Requirements for Production Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Production of raw materials in university labs? Lean in Manufacturing and Service Industries 11
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
V ISO 9001: 2015 Production drawing Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Determining Calibration Frequency schedule for items used in production Manufacturing and Related Processes 2
T Customer audit demands - that I state in my QM who can shut down production AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
R IATF 16949 Clause 8.5.1.6 a) maintenance and repair facilities - Production tooling management and personnel IATF 16949 - Automotive Quality Systems Standard 4
Q IATF 16949 certification without automotive products in "production" IATF 16949 - Automotive Quality Systems Standard 5
Ed Panek Small Medical Device company - Bring production in-house ISO 13485:2016 - Medical Device Quality Management Systems 1
Mr Skeleton PV (Production Validation) test plan responsibility APQP and PPAP 21
D Valeo 5 Axes and VPS (Production System) Lean in Manufacturing and Service Industries 1
C Medical Device Stability Studies - Non-validated pilot production Other Medical Device Related Standards 1
Ed Panek Moving from Contract Manufacturing to Production In-House ISO 13485:2016 - Medical Device Quality Management Systems 3
andika_untoro What are a good Critical to Quality (CTQ) metrics for a biotech manufacturing production? Lean in Manufacturing and Service Industries 0
L Why is initial production units, lots, or batches, or their equivalents required for Design Validation? US Food and Drug Administration (FDA) 3
chris1price MDR Conformity Assessment for a Class 2a device - Production Quality Assurance EU Medical Device Regulations 2
Ed Panek Observational Audit of Contract Manufacturer Production ISO 13485:2016 - Medical Device Quality Management Systems 5
P AS9102 full FAl or a partial FAI after production inactivity period AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
Sidney Vianna AS9100 News PPAP in the Aerospace Sector - What is it? AS9145 - Requirements for Advanced Product Quality Planning and Production Part Approval Process AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
W AS9120B 8.5.1 Control of Production and Service Provision AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
N In-Process Production Test Stations in PFMEA (Process FMEA) FMEA and Control Plans 18
Q Methods to Calculate Available Production Rate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
T Logic that determines what production testing is needed ISO 13485:2016 - Medical Device Quality Management Systems 2
G Medical Devices: Product/Production Quality EU Medical Device Regulations 2
R Mass production handover check sheet (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 1
H Informational What is PPAP (Production Part Approval Process)? APQP and PPAP 22
C Documenting Cleaning Production Lines in Medical Device Pkg facility ISO 13485:2016 - Medical Device Quality Management Systems 1
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Similar threads


















































Top Bottom