Quality System Consulting

Helping to Increase Your Productivity, Profitability and Employee Knowledge

Ainslie provides you with an individual with interpersonal skills, the ability to help generate clear concise documentation and give direct, hands on coaching of employees. These are some of the reasons for utilizing Ainslie. Below is an overview of our cost effective activities which will reduce the time your full time people spend to achieve your objectives.

Planning & Implementation

Review current systems for AEROSPACE, FDA QSR/GMP compliance, ISO Quality System Standards, and EU Directives to identify any gaps in coverage.
Develop a customized, detailed, goal oriented, task list, schedule, and plan.
Provide on-site guidance and evaluate procedures and work flow as the plan develops.

Documentation Preparation

Write a Quality Manual that will be accepted by your registrar
Document your company’s intra and inter departmental processes
Document your company’s work operations
Design and index records as evidence of procedure performance

Assessment Preparation

Assist in choosing an appropriate registration partner if requested
Conduct mock assessment to determine whether your program is third party/registrar ready
Assist with pre-assessment and third party audits
Prepare employees for regulatory inspections
Teach employees to correct problems found during pre-assessment and registration audits

Facility Surveys & Audits

Review company program documentation prior to release.
Perform internal quality system audits to identify non-conformances.
Provide Guidance on modifying system documentation and performance.

Regulatory Requirements

Train employees in appropriate administration of the Corrective Action Process (Root Cause Corrective Action)
Teach effective Preventive Action process (Continual Improvement)
Advise companies on proper management of internal and external complaints
Coordinate and monitor product and process Verification and Validation
Analyze patent content and technology

Give your company the edge. Contact quality management consultant Alan Broadwin at (914)948-1498, for expert business advice.