A product is a sum total of the inputs or the raw materials and the processes that convert it to a finished good. While a manufacturer may be implementing a culture of quality inside its own organization, without the right supplier quality framework, the quality and compliance effort is incomplete.
3 Reasons Why You Need Supplier Qualification
- 1.Supplier qualification is an important tool for risk assessment to identify and mitigate the associated risks with materials, components, and services offered by third parties outside your organization. It is an absolute necessity in most sectors, but more so if you operate in highly regulated sectors like healthcare and life sciences, aerospace, cannabis, to name a few.
- It is a regulatory requirement, specified by ISO 9000, GMP and so on, depending on the industry one operates in. These regulations hold the manufacturer responsible for the quality of the end product. Therefore, it is in the best interest of the companies to ensure the quality of their suppliers to avoid being penalized in case of any non-conformance.
- Any defect or delays in the end product will cost the manufacturer – both financially and operationally. While suppliers are outside your organization, it is critical to realize that their quality directly impacts your quality.
8 Factors to Qualify Suppliers
Quality here is not just the robustness of the product alone, but also encompasses the following nine characteristics:
- Timely delivery
- After-sales service
- Responsibility towards society
Broadly, there are two stages to qualify suppliers:
Pre-qualification – conducted at the early stage, it involves assessing potential suppliers
Re-qualification – involves constantly qualifying active suppliers who are still under contract
Typically, the process of qualifying a supplier involves sending a questionnaire to the supplier. The questionnaire is based on the following:
- Establishing risk analysis rules and assigning a risk class to the supplier, based on the type of product or service they provide. The raw materials themselves are classified as critical to non-critical, with higher weight given to the critical ones
- Establishing qualification criteria and matching supplier’s capabilities against it, setting a score and validity period. This is analyzed and validated with a detailed audit of the supplier’s site.
- Identifying areas of improvement and defining the action needed
- Monitoring and guiding the course of improvement
If the supplier is selected after the pre-qualification stage and a contract signed, the process is repeated to make sure the required quality is maintained.
Supplier Qualification Management
While the need for and impact of supplier qualification is straightforward, it is not an easy task. A manufacturing company typically works with more than one supplier and more than one product from each supplier. To set criteria of qualification for each, to verify each product of each supplier against the criteria, to keep track of improvements, to update the records, to maintain an audit report, to refer to the earlier criteria at the time of requalification, and to present the proof as part of regulatory requirements… It is humanly impossible to achieve this in a manual system. Automation is the only way forward.
A flexible, web-based QMS such as the one from ComplianceQuest can make the task easier to manage efficiently. Built on SalesForce.com’s cloud-based platform, the scalable QMS from CQ comes with a host of features specially designed for the supplier qualification needs of different industries.
Its features include:
Supplier Onboarding and Change Management is highly configurable, fast and cost-effective, improving supplier accountability through intuitive supplier portals.
SCAR – Supplier Corrective Action Requests process intimates suppliers in case of any downward trends so that they can take timely corrective and preventive actions and permanently address challenging issues.
SAR – Supplier Audit/Survey Responses is an audit workflow engine that provides best practice functionality to conduct all types of audits, while recording findings, linking with the SCAR process for timely correction, generating reports, and analyzing trends of supplier audit management performance.
Document Exchange process allows users to securely distribute, track and control access to the latest versions of content such as product drawings, manuals, brochures, certificates of analysis, certificates of compliance, sales collateral, etc., from a browser or within a tablet device. Suppliers are given access to the relevant content from a central and real-time repository of information.
Supplier Rating and Score Card provides robust supplier rating capabilities for setting parameters such as risk levels, product family, class of supplier and so on while benchmarking their performance. Unique scores for each supplier can be generated using quantitative and qualitative attributes for enabling continuous improvement in reducing the cost of quality and improving their performance.
PPAP or Production Part Approval Process helps manage new parts/materials and change requests more effectively by involving the suppliers and providing them a view into the status of their requests, thereby reducing the risk of non-conforming products and delays.
CQ’s Supplier Deviation Request (SDR) enables a closed-loop process to manage short-term supplier deviations for specific parts/materials to reduce data errors and prevent a recall. Suppliers electronically submit their deviation request details along with the reason for the request and corrective actions performed and receive an alert when the user has approved or rejected it for further action.
ASL – Approved Supplier List helps the purchasing team to maintain and update the list of suppliers for ready reckoning.
Collaboration, mobile access, reporting and analytics, and social media enablement are some of the other features of the tool.
ComplianceQuest has experience working across seven industry segments – Aerospace and Defence, Automotive, Cannabis, CPG, Manufacturing, Hi-Tech, E-commerce and Life Science. We are especially equipped to cater to the Life Sciences, Automotive and Manufacturing segments. We also have expertise in regulations specific to various industries such as FDA, IATA, ISO, AS and OHSAS.