Application Note – SOP N.1 – The correct SOP

The correct SOP

SOPs are typically created using Microsoft Word, printed out, and stored in three-ring binders.

The binders are then routed physically from one approver to the next. 

Once approved, the content of the binder is photocopied so every affected department will have one binder handy.

The possible negative aspects of a SOP

The most common negative aspects are: 

(a) Inefficiency

(b) Poor Communication

(c) Lack of Training

(d) Ineffective Documentation

(e) Poor Revision Control

(f) Poor Collaboration

(g) Lack of Visibility

(a) Inefficiency

The process of routing, reviewing, and approving a SOP can be slow and inefficient.  This is especially true if an organization generates hundreds of SOPs and the people who need to review and approve them are in different location. It is likely the SOPs may get lost while being routed, either buried in someone’s messy desk or computer “in” box. Search of SOPs would entail sorting through voluminous paper work. Updating SOPs would be equally slow.

(b) Poor Communication

In a manual system, quality processes are not connected, making it hard for people who operate those processes to communicate. To speed up the approval of a SOP, the originator needs to make phone calls, send e-mail messages or remind approvers in person, and that is just one SOP! Multiply the number of phone, e-mail, and personal reminders a dozen times for an employee responsible for a dozen SOPs.

SOPs are likely to be updated, but people affected by the changes may not be notified in a timely manner.

(c) Lack of Training

Employees may be using new SOPs, but they may be doing it poorly without the appropriate training.

(d) Ineffective Documentation

Effective implementation of SOPs has a direct impact on product quality, and that is why it is critical for organizations to capture and up-to-date information in SOPs.

It is sometimes difficult to rely on employees to always remember to document any changes in an SOP, including who made the change, why, and when.

(e) Poor Revision Control 

After SOPs have been revised and approved, old documents may re-surface on the shop floor. Another problem is that employees may use documents that have not been approved simply because they are able to grab that binder sitting on someone’s desk. In both cases, using uncontrolled SOPs could lead to nonconformity.

(f) Poor collaboration

Creating and updating SOPs usually require collaboration. Collaboration is relatively easy when employees are based in the same facility and with the same schedules. Collaboration is quite difficult among employees with varied schedules and responsibility and who are based in different facilities.

(g) Lack of Visibility

Paper-based processes are not connected, making it difficult for management to monitor the effectiveness of  SOPs and make timely decisions.

Conclusions

For FDA-regulated and ISO-certified companies, SOPs are more than just a tool of operation. SOPs directly affect product quality, and therefore, compliance. Development of effective SOPs and implementing them properly require commitment from the entire organization. Choosing the right software solution that will facilitate and improve SOP management should be a part of this commitment. Once established, an efficient and effective SOP management system will serve as a foundation for an organization’s sustainable compliance and long-term success in the market.

Reference

SOP Management as a Compliance Tool in FDA and ISO Environment – 2006 MasterControl Inc. 

White Paper. Page 4 and 5. www.mastercontrol.com