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At Procurabl our focus is on delivering efficiencies for our clients. While cost and time matter, quality is something that we are very particular about. In this article, we share how can you, ensure that you always receive good quality products, first time, every time.

The majority of the time, poor quality is the result of poor production management. Whether it's due to a manufacturer's cost-cutting, a lack of training at their plant, or a lack of a defined QC/QA plan, the clients suffers a loss most of the time. Manufacturers who implement quality control processes are significantly less likely to incur product recalls or put customers in danger as a result of poor workmanship.

Following are the few steps which buyers should take to ensure the quality of components being manufactured at partners’ facilities.

Defining Quality Assurance and Quality control plan

A quality management plan includes quality assurance. It refers to all of the processes in a quality plan that ensure that the product is ready for the manufacturing process. In other words, QA ensures that the quality requirements you set will be met as the products are manufactured. The inspection phase of quality assurance is known as quality control. It's a set of tests used to ensure that a product is safe, durable and effective after it's been mass-produced.

Defining quality acceptance criteria (QAC)

Quality Acceptance criteria are a collection of specified requirements that must be completed in order for a task to be considered finished. Because they define the scope and standards that must be fulfilled by the contract manufacturer. These criteria must be communicated to all stakeholders before validating the project scope or SOW. It is recommended to set clauses for rejection and non-conformance while drafting the contract. Any changes to the QAC need to follow a hierarchy of change management and be documented in the project's file. Effective and timely communication is the key to maintaining the key requirements in check for all stakeholders. Following are the key highlights of an effective QAC:

  • Acceptance criteria should be measurable.

  • Acceptance criteria should take the end user's perspective into account.

  • Criteria should be clear and concise without any ambiguity.

  • Acceptance criteria must be understood by all

QC Provision in Contract

The contract should specify all duties and manufacturing operations for each organization, as well as the proper contact person. Requirements for quality reports and sampling plans should be specified in advance. If a third party contract testing lab is involved, all relevant roles and responsibilities should be defined. The contract should explicitly state what data will be shared along with the outline of change management activities.

Processes such as corrective and preventive actions (CAPA) and deviations management need to be defined with a reasonable timeline within the project schedule. There should be a clause in contracts requiring contract manufacturers to seek validation if they want to use a different facility or collaborate with a different subcontractor. In the contract, set response times upfront. When communicating with contract manufacturers, quality organizations rarely receive a response within 24 hours.

This delay can cause problems for the function, particularly during product investigations or other issues. Hence it is recommended to set up communication requirements upfront–at the time the contract is signed–to prevent delays and quality issues. In addition to these provisions, there should be mentioned penalty clauses to compensate for damage for quality rejections and late deliveries. Also, set a time limit to perform an inspection after receiving the parts to claim the warranty. Finally, the contract should involve terms and conditions of record accessibility and auditing plans.

Tracking Progress

Buyers can set up the checkpoints and non-conformance metrics in the project schedule to ensure the work being done at the contract manufacturers is up to the mark. Quality audits and checks can be effective when there is effective data recording of pre-production, in production, and pre-delivery inspection at the facility. Meet with your contract manufacturer's quality equivalents on a regular basis. Use this opportunity to brainstorm solutions to current problems and debate ways to improve.

Inbound Inspection

Inbound inspection, also known as receiving inspection, verifies the quantity and quality of purchased raw materials, parts, or components against predetermined acceptance criteria. If the quality is not satisfactory as per the set QAC, utilize the warranty time limit specified in the contract to inform the supplier. As per the scenario and the product category the issue can be resolved through rework, replacement or penalty settlement. Quality claims should be aligned to the signed contract to proceed with the resolution.

Contract manufacturing arrangements relationships are complicated. Cost-cutting through contract manufacturing is possible without sacrificing quality. At Procurabl we manage everything with proper planning, documentation, supervision and collaboration. Check out how we manage quality assurance here, and contact us to know more.

Ninad Kashid

Jan 2, 2023


How to ensure quality in Contract Manufacturing

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