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What is Quality Management?

Quality Management ensures that the features, design, functionality etc. of a product/service, and the processes carried out for the production/delivery of the product/service are compliant with quality policies. Quality policies are established by management and quality experts to ensure consistent excellence of the product/service. Quality Management primarily incorporates quality planning, quality control, quality assurance and quality improvement. Poor quality management leads to increased cost and decreased customer satisfaction.

The Challenges

  • Several industries are being heavily regulated. They constantly face the challenge of meeting rising quality standards and comply with rigorous regulatory requirements.
  • As regulations like FDA 21 CFR Part 11, 21 CFR Part 820, 21 CFR Part 210-211, CFR Part 820/QSR, CFR Part 606, ICH Q7A ISO 9000, ISO 13485:2003, GXP (GMP, GLP, GCP) are increasing, companies are faced with ambiguity on which regulations apply, how these impacts internal audit, behavioral risk, operational risk, evidence, policies and procedures.
  • Legacy and homegrown systems, stand-alone applications, paper or spreadsheet based systems used by various organizations to manage product and process quality and compliance fail to address systemic quality problems as they lack a broad enterprise reach.

Our Solution

360factors offers a Quality Management Software platform to automate compliance to various regulations like GXPs, FDA, ACA, MHRA, ISO and Annex 11, and increase quality production. It allows businesses to develop a risk-based method to quality and compliance management, and deliver a common structure with an integrated approach to meet FDA regulations through risk management, document control, auditing as well as recording and reporting.By using an efficient approach to quality and compliance management and organizing a single platform to manage the multiple enterprises, companies can attain improved business performance through more control, implementation and monitoring of critical business procedures. 360factors solutions integrate processes, diminish risks, simplify information streaming, improve operational proficiencies and help accomplish desired quality levels and compliance requirements.

Key Features

360factors provides a single platform to manage the following functions effectively:Quality Management Function

Predict360 ensures seamless integration with your ERP systems.

Try incorporating the following five steps of the Quality Management Process for success at your organization.

FIVE STEPS OF SUCCESSFUL QUALITY MANAGEMENT

Step One: Create a Quality Plan

A quality plan enlists the quality standards, quality policies, requirements and best practices that pertain to a particular product or service. Implementation of this document ensures that the organization meets its quality objectives as well as customer’s expectations and requirements.

Step Two: Align Quality Targets with Quality Policies

Enlist all manufacturing processes that have any bearing on the end product. Assign quality target values to each process in accordance to quality policies; these values signify the number of permitted discrepancies per 1000 opportunities or incidences of the process. Quality targets help achieve ‘zero risk.’

Step Three: Quality Assurance and Quality Control

Quality assurance ensures minimized defects in manufactured products, and the reduction of problems when delivering services or implementing solutions. Quality Control is the testing of samples from the total production output in order to ensure that quality standards and requirements are met.

Step Four: Develop Quality Measurement Techniques

Quality Measurement Techniques involve the assessment of the performance of the product against the level of customer satisfaction. Developing and employing quality measurement techniques ensures continual improvement of processes and increased customer satisfaction due to improved product quality.

Step Five: Quality Improvement

Quality improvement is a continuous cycle of evaluating performance/results followed by taking measures to improve performance; for e.g. evaluation and improvement of specific processes in the production/manufacturing of a product or evaluation and improvements of features, design etc.