Maintaining quality can be complex for companies in highly regulated industries. Every part that they and their suppliers manufacture must meet strict compliance and regulatory requirements. As a result, supply chain quality and audit preparedness often rise to the forefront of operational efforts.
Much of the quality process can be managed electronically with a quality management solution, eliminating the need spreadsheets or redundant data entry while improving efficiencies.
The following are some key quality improvements for highly regulated manufacturers that can be realized using an efficient quality management solution:
Aerospace & Defense Industry
• Support of important compliance regulations such as AS9100 and ISO9000
• Complete product genealogy and shop floor control
• Effective Maintenance, Repair and Overhaul (MRO) tracking
• Compliance to DoD requirements for counterfeit parts avoidance, mitigation, and disposition
Commercial Space & Satellite Industry
• Support of mission assurance and regulatory compliance
• Enables root-cause analysis
• Facilitates rapidly evolving operations and innovation
Complex Manufacturing Industry
• Lowers cost through decrease in non-conforming products
• Reduces on-hold MRB material
• Integrates configurable system for multiple plants
• Enables Paperless processes
Medical Device Industry
• Effective document control
• Delivers risk mitigation tools
• Maintains Regulatory Compliance such as ISO:13485
• Complaint handling integrated with closed loop corrective action
• Supports a lean manufacturing approach
• Enables control of critical components & assemblies
• Provides visibility and tracking of the supply chain
• Enables efficient energy production
• Supports nuclear power (NRC standards)
• Encourages environmental health and safety
An efficient quality management solution provides full visibility into the product lifecycle and tracks quality from procurement through manufacturing, assembly, repair and field support activities. Product quality issues can be quickly identified and a CAPA process can be implemented to prevent reoccurrence. Additionally, highly regulated manufacturers can remain audit ready by automating the compliance process and streamlining workflows. With the right software in place, audits can be painless.
It’s important for a company to choose a provider that is well-versed in industry regulatory requirements and has experience helping companies make lasting quality improvements. For almost 30 years, TIP technologies has partnered with manufacturers to solve the complex supply chain management, quality management and shop floor control issues that are an inherent part of the highly regulated manufacturing marketplace. TIP Technologies is the recognized leader in comprehensive commercial off-the-shelf quality solutions, with a proven track record of cost effective implementations that simplify the highly regulated manufacturing environment. Contact us for an industry-specific demo of our TIPQA Quality Management Solution and learn how you can make similar improvements in your organization today.