It is easy to find tools and techniques for the implementation of QMS – Quality Management Systems. Technical knowledge to solve complex problems are also easily available. Still, companies continue to face all sorts of quality problems, adverse inspection reports, complaints & recalls without realizing the underlying reason. During my working in various roles, I was able to understand such issues and realized that there are some very basic links that are missing or weak. This provided me an insight into the working of the organisations particularly related to QMS

QMS Insights is an endeavor to cascade the vast knowledge and experience that I gained from different organisations across many countries. I want to share insights into how some companies are able to develop mature quality systems and others do not.

I have 36 years experience of working in Quality and Manufacturing functions out of which the last 15 years were spent as a Quality Auditor.

Area Of Expertise

Quality Audits

  • Performing audits of food and pharmaceutical companies, raw material and packing material suppliers of all types in any geographical region, globally. These can be on site audits, desktop audits or Remote Audits – the new type of audits necessitated by the COVID 19.
  • Preparing sites for audits, and certifications. 
  • Training teams on facing audits and preparing trained auditors.

QMS Implementation

  • Implementation of Quality Management Systems based on the company QMS, regulatory requirements.
  • Quality Documentation: Manual, SOPs, Work Instructions and designing and preparation of Quality Records
  • Specific gap analysis against any given standard and making action plans for plugging the gaps

Training

  • Development of training modules related to Quality, Technical Aspects, Quality Mindset, and Culture.
  • Imparting of training – onsite or remotely
  • Identifying training needs and implementation of training programs and calendars

Data Integrity

Creating understanding of the need for Data Integrity. Data Integrity Principles. Developing Data Integrity Action Plans. Specific Data Integrity Audits

Microbiology

Solving microbiological problems related to product Quality.

Other Areas

  • Implementing General and Quality Risk Management programs.
  • Implementing Remediation plans for sites having multiple or repeat problems.
  • Process Improvement projects for Quality Improvement.