Many pharmaceutical companies struggle to close change controls. Clients often ask if the problem is caused by too many change requests and what is a reasonable number of open changes.

The issue for most sites is not the number of change requests, but how old they are.

Is there a problem if our site has high change control numbers?

No. High change control numbers may just be an indication that a site is making lots of changes – large site-wide projects, implementing changes in response to a poor audit performance, implementing capital improvements etc. It’s when change controls are not closed out and remain open from month to month without any completed actions, that there is a problem.

Is our site change control system under control?

There are some key factors in maintaining quality systems in a state of control and still ensuring procedures are flexible enough to preserve usability. The following discussion will help you diagnose points of control for your change system that may need strengthening on your site. These principles are focused on change control but may equally be applied to other quality systems.

1. Strong QMS processes

It is impossible to maintain routine control of change control numbers with a poor or weak process. If the procedure is confusing, does not integrate with other quality systems or allows too much procedural latitude, then it will be difficult to prevent ‘blow out’ of change control numbers.

Change control procedures that have a good balance of flexibility, thorough impact assessment and QA/senior management oversight to approve implementation before changes are made, tend to perform much more consistently.

2. Assigning due dates and change owners

It is imperative that basic planning be applied to all change control implementation – this means assigning a due date (expiry date) and a single change owner who is responsible for facilitating the implementation of the changes that are approved to commence.

QA should also track the status of site and department change controls each month (open, closed, expired etc.) and trend over a 12 month period so that there is transparency to senior management on the ‘health’ of the process.

3. Attentive management oversight

Senior management must enforce the requirements of the change control procedure and review monthly metrics so that change owners are accountable for meeting the due date and implementation requirements. Recalcitrant changes may require senior managers to follow up using change management practices to ensure timely closure. If additional time is required or other changes necessary, then these must be communicated and approval sought in a timely manner.

Escalating or continuing expired change controls are a warning to senior management that the change system is not under control and is therefore a high audit risk. The PIC/S Code of GMP requires that a company QMS is robust enough so that any changes are made in a compliant, controlled and coordinated manner.

Often companies that have monthly management review of change control metrics have the best control of their open change requests.

4. Adequate resourcing

Sometimes change control numbers are out of control because there are not enough resources to manage all the changes required at any one time. Chronically under-resourced departments often have a track record of numerous, expired change controls from month to month.

Senior/department management are ultimately responsible for ensuring there are adequate resources for those changes approved to commence. If this is not the case, then senior managers must prioritise those changes approved on site. Alternatively, they may initiate an investigation into root cause or process improvements when resourcing is believed to be at an appropriate level.

How many open change controls is appropriate?

There is no standard, magic number of change controls per:

Site size
Staff numbers
Batch volumes etc.

Some companies set operational time frames for closure based on level of risk or complexity. However, number of open change controls (not expired change controls) should be flexible to meet the requirements of the site at any one time, so long as they are resourced.

So how do you reduce the numbers?

Sites with significant out of control change numbers should determine the root cause of the numbers increase and implement corrective actions – process improvements, better visibility, oversight and accountability, resources etc. For an interim period, additional resources or initiatives may also need to be assigned to close the gap.

Many companies, regardless of size or GMP maturity, sometimes struggle to maintain their change control numbers. However, it is sites that maintain surveillance across key quality system metrics and act early to address increasing trends who avoid prolonged out of control numbers.