Are you still using paper and spreadsheets to record and track critical information about your business? You're not alone! Document management experts estimate that 90% of corporate data resides on paper or in an unstructured format!
If you are in the Life Sciences Field, if your business specializes in manufacturing related to biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental or biomedical devices, your document trail responds to a variety of complex demands, including document management, investigations/CAPAs, training, audits and supplier management.
Quality management standards help "organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product." Over 1,000,000 companies worldwide have ISO 9000 certification, ensuring that their companies use a quality management approach of eight principles and that they comply with statutory and regulatory requirements.
These eight principles involve issues such as customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, factual approach to decision-making and mutually beneficial supplier relationship.
None of these issues specifically deals with the bottom line, however, so even if you meet ISO 9000 standards, you don't necessarily meet them in the most cost-effective way possible.
What do we know about the life cycle of a record, whether on a piece of paper or electronic? We know that the first stage in the life of a record is input. Following that procedure, you must retrieve records, manage records, revise records, collaborate based on records, track records and retain them.
Analysis of records takes them to another level, sometimes involving small pieces of information in one record correlating to information in many other records to provide critical information to stakeholders, business owners, management, customers, investors, suppliers and regulatory bodies.
Waste and cost occur at the most basic level: retrieval. In a highly efficient paper-based filing system, it takes an average 6 minutes to retrieve and refile a document. If files are at individual desks, however, instead of in a file bank, that 6 minutes stretches to many more. And what if you can't find the record? Now imagine you need a number of files in order to analyze data across them? Multiply that 6 minutes by the number of files you require, and in addition, add the time it takes to locate data within the files and create a mechanism to correlate it for analysis. You can quickly see where all of this goes -- to thousands of dollars a year.
Paper management experts note these statistics:
- Companies spend $20 in labor to file a document, $120 in labor to find a misfiled document, and $220 in labor to reproduce a lost document.
- 5 percent of all documents get lost, 3 percent of the remainder get misfiled.
- Professionals spend 5-15 percent of their time reading information but up to 50 percent looking for it.
- There are over 4 trillion paper documents in the U.S. alone, growing at a rate of 22 percent per year.
Let's think about that for a minute. In a perfect world with no filing errors, no misplaced documents and no lost documents, if you need to retrieve and refile 50 corporate documents in a day, it costs you 5 hours a day and $75 a day at $15/hour for 250 working days per year. That's $18,750/year you could have spent elsewhere.
As computers reduce the need for traditional secretaries leaving professionals to handle their own work, you're possibly paying high level professionals to input or retrieve information when they could give their attention to higher level tasks.
That's just a simplistic, minimal idea of the amount of waste involved in a paper-based system. This quick view doesn't even begin to address using those records for sophisticated analysis of business trends or issues of quality control. It doesn't deal with tracking down bottlenecks in the system or ensuring that you can implement and monitor timely corrective action when you find them. Collaboration both inside and outside an organization has limits due to the difficulty of accessing a common record or dealing with changes and revisions systematically. It's simply not possible to do these tasks effectively in a paper-based system.
And home-grown or paper-based systems add undue risk given the demands of today’s regulators and customers. Accountability and compliance are time-consuming operations in a paper-based environment.
Consider that number: 4 trillion paper documents in the U.S. alone. It's mind-boggling to think about it. Consider the cost of all that paper packed into desks and drawers and the time involved in drawing meaningful, coordinated information from it.
ZenQMS offers a risk free way to immediately improve your quality profile. We offer Cloud and SaaS (Software as a Service) software that provides global information access. ZenQMS immediately connects all your employees and facilitates collaboration with external partners on Audits, CAPAs and more. Our software is as easy to implement as setting up with Gmail, and you can have unlimited users.
No more filing and retrieval headaches, and none of the costs associated with that expensive and wasteful paper-based system. Never go hunting across the office again for an important piece of paper. Make your critical information globally accessible and eminently useful. We are here to help you with any configuration or data migration needs you may have.
Please contact us today to talk about how we can improve your quality management, making it more effective, more accountable and more cost-effective.