Are you really confident about your quality management system?

Good quality management practices (GQMP) is in the top most priority for few of the industries like Pharmaceutical, Life Science and Heath care. You may be confident that your system is perfect but there are few hidden flaws most of the companies failed to notice until it’s too late.

So let’s identify those hidden flaws of your quality management practices so that you can fix and improve them before being late.

Ineffective document management

Effective documentation is the very important part of good quality management practices but till now most of the companies are considering it as granted, following traditional methods like shared drive, email for managing various documents like test methods, product specifications and work procedures. Any pharmaceutical company need to manage 1200-1500 SOP’s with time to time versioning and updations. So the probability of these below mentioned situations are very high:

• Struggling to find required document
• Unsecure system and decentralized
• Your office becoming cluttered with paper and files
• You often loose and misplace documents
• Time/effort/cost consuming

Lack of proper training

After effective documentation, effective training management system is the area where most of the companies are lacking. Regulatory guide lines are changing very rapidly so to in line with current trend you have to train your workforce constantly but in manual system you will face these below mentioned complexities:

• Lack of information and knowledge to the new comers
• Struggling to identify the individual training needs
• Often found that operators or employees are using old SOP’s
• Often found missing step in procedure
• Poor cleaning, untidiness and eating in production areas
• Confusion of the right materials to use
• Failures to follow labelling rules

Poor supplier management

Your suppliers have a direct impact on your company, brand and compliance management. So supplier quality management is very important. Which is again the concern area for most of the Pharma players and face many challenges like:

• Gap between what you want and what your supplier deliver
• Unable to identify potential suppliers
• Growing no of rejections, wastes, rework and returns
• planning delays and production interruptions
• Low visibility and control over quality

Ineffective continuous improvement practices

Yesterday’s quality management system has transformed into today’s risk management system. Today the need to adopt a proactive approach rather than to have a reactive approach. But is found that many organizations sideline or forget to pay more attention towards CAPA which is the backbone for the continuous improvement and face:

• reasing no. of non-conformities
• Lack of interlinking between various QMS processes
• Lack of control and visibility on organizational CAPA practices

Inability to integrate

Within manual quality management system every department/process is a standalone process so unable to provide integration within your various processes hence the chances of something falling through the cracks and creating problems down the road is always high.

For example, document changes may require updating employee training, and any audit will most certainly uncover noncompliance’s that need to be entered into the CAPA system.