My experience has taught me that most of the manufacturing quality problems can be addressed with proper implementation of quality standards. It is very important for all quality personnel including technicians, inspectors to understand these standards and comply accordingly. Lack of proper procedures in place and urge to comply to standards for the sake of audits, assessments would lead to disorganization within quality function. A most effective way to ensure proper compliance is in embedding the quality assurance culture in daily tasks.
My first step would be to ensure local site QMS and standard operating procedures (SOP) of critical processes are aligned to international & corporate quality standards. These documented procedures shall be developed in order to ensure organization understands the processes, how to execute them in sustainable manner, assign responsibilities and ensure its execution. This is a challenge since international quality management standards like ISO 9001, ISO 13485, IATF 16949 give broad scope of how quality function shall take place in a company. Translating these requirements into site-level quality manual and into operating procedure requires deep understanding of both subjects. Companies with multiple plant locations monitored by a single division often have same generic operating procedures for key functions such as controlling of non conformance products, supply chain management etc. The problem with such documents is although the functions remain similar among all these plants, there will be a lack of detail in elaborating responsibility of each individual. This would often lead to confusion as to what the individual is actually supposed to do at his work. SOP’s customized to individual plants are a great way to eliminate this confusion. This can help an individual to understand his role in the organization and the duties expected of him within the organizational scope.
My second step would be ensuring all key personnel from various functions are aware of these procedures and understand their responsibilities. Most of the auditees i audited throughout years, either have no idea of existing SOPs for their function or do not have easy access to such documents. A quality personnel shall take responsibility in ensuring this doesn’t happen. Formal awareness and visibility of these documents would ensure critical tasks and activities are being addressed and resources are prioritized to support. Once developed and implemented, these processes (and its procedures) should be subject of the QMS audits, to ensure compliance and control. This would be a good start in ensuring good quality assurance program in a company.
How do you prepare for internal and 3rd party audits? Do you make sure the local procedures are updated and are in compliance with latest standards? Let me know in the comments below.
In my next blog, I’ll share my experience working within the Quality Control function and the challenges manufacturing companies face in today’s economy in dealing with quality problems.
Quality Thinking 