Change Control in the Regulated Industries

In my last post, I described change control process in general and I mentioned that in the regulated industries, manufactures are required to use a change control procedures I am going to describe this change control procedure in this post.

A change control procedure is usually one of standard operating procedures (SOP's). It usually includes a change control form. Some companies also use change request forms for suggested changes. This procedure usually includes the following components:

Identification

The identification of the changed device, assembly, component, labeling, packaging, software, process, procedure, manufacturing material, and any other related item or document. The change control form has blank spaces for recording this data.

Effective Date

The effective date of the change which is usually a completion date, or an action to be performed when a specific event occurs, such as "implement the change when the new part is installed, validated, and operational." The blank on the change control form for recording the effective date should not be left empty.

Responsibility

The change procedure should state which department or designee is responsible for each function to be performed.

Revision Number

The change procedure should describe the way the revision level is to be incremented. It is common practice to use sequential numbers for revisions.

Communication

The change procedure should describe the communication of changes to all affected parties such as production, purchasing, contractors, suppliers, etc. As appropriate, the document might include activities that apply to internal operations. Examples are employee training, rework, or disposition of in-process assemblies, use of revised drawings and/or procedures, and disposition of old documents.

Updating Documentation

The change procedure should cover updating of primary and secondary documentation such as instruction manuals. Usually there are no problems with updating or revising primary documentation -- in fact, that is a major reason the given change order is being processed. In contrast, it is rather easy to forget that related secondary documents such as component drawings, instruction manuals or packaging require revision if affected by a given change. The use of a good change control form can alleviate this problem.

Documentation Distribution

Revised documentation should be distributed to persons responsible for the operations affected by the change and old documents removed and filed or discarded, as appropriate. After updated documents have been approved, these documents have to be made available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents have to be promptly removed from all points of use or otherwise prevented from unintended use.

Remedial Actions

Certain changes may require remedial action. Changes of this nature should be addressed in the change control procedure.

Regulatory Submissions

There may be changes may that require a regulatory submission. The change control procedure should specify if regulatory submissions should be considered when making a change.

Business Factors

The change procedure should also cover other factors such as financial impact, modification of sales literature, update of products in commercial distribution, etc.

Quality Assurance Review

The change procedure should cover if the quality assurance review is required for the change.

This change control procedure is also used for document control.

Changes to documents have to be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval of these documents unless there is a specific designation that states otherwise. These approved changes have to be communicated to the appropriate personnel in a timely manner. A company has to maintain records of changes to documents.

Change control for documents should include:

• identification of the affected documents;
• a description of the change;
• revision number
• the signature of the approving individual(s);
• the approval date;
• the date when the change becomes effective.

In a case of the regulatory agencies inspection, the change control procedure is usually audited.

Change Control

Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.

The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change.

Change control is used in a wide variety of products and systems. For Information Technology (IT), it is a major aspect of the broader discipline of change management. Typical examples from the computer and network environments are patches to software products, installation of new operating systems, upgrades to network routing tables, or changes to the electrical power systems supporting such infrastructure.

Change control process can be described as the sequence of of six steps: record/classify, assess, plan, build/test, implement, close/gain acceptance.

Record/classify

A user initiates a change by making a formal request for something to be changed. The change control team then records and categorizes that request. This categorization would include estimates of importance, impact, and complexity.

Assess

Change control team makes an assessment typically by answering a set of questions concerning risk, both to the business and to the process, and follow this by making a judgment on who should carry out the change. If the change requires more than one type of assessment, the head of the change control team will consolidate them. Everyone with a stake in the change then meet to determine whether there is a business or technical justification for the change. The change is then sent to the delivery team for planning.

Plan

Management will assign the change to a specific delivery team, usually one with the specific role of carrying out this particular type of change. The team's first job is to plan the change in detail as well as construct a regression plan in case the change needs to be backed out.

Build/test

If all stakeholders agree with the plan, the delivery team will build the solution, which will then be tested. They will then seek approval and request a time and date to carry out the implementation phase.

Implement

All stakeholders must agree to a time, date and cost of the implementation of the change. Following the implementation, it is usual to carry out a post-implementation review which would take place at another stakeholders meeting.

Close/gain acceptance

When the user agrees that the change was implemented correctly, the change can be closed.

Change Control in a Regulatory Environment

In a Good Manufacturing Practice (GMP) or ISO 9001 regulated environment, change control activities and procedures apply to software, labeling and packaging, device manufacturing processes, production equipment, manufacturing materials, and all associated documentation such as quality system procedures, standard operating procedures, quality acceptance procedures, data forms, and product-specific documentation. Change control is also applied to any production aids such as photographs and models or samples of assemblies and finished devices.

Any regulated industry has a compilation of documents containing the procedures and specifications for a finished product. It includes specifications and all other documentation required to procure components and produce, label, test, package, install, and service a finished product. Manufacturers are to prepare, control changes to, and maintain these documents using change control procedure which is in fact the document control procedure.

In my next post, I will describe the change control procedure as it applies to documentation in a regulated industry.

Engineering Change Process

Let's look at the engineering change process and how Engineering Change Order (ECO) is used in this process.

The stages of the engineering change process are:

1. Issue identification & scoping:

Someone identifies a problem or issue and determines that it may require a change. The scope of the issue and its possible impact are estimated.

2. ECR creation:

An engineering change request (ECR) is created to examine the necessity and feasibility of the change, to identify parts, components and documentation that might be affected, to estimate costs and to list the resources required to implement the change.

3. ECR review:

The ECR is circulated for review and discussion among key stakeholders and is modified as needed.

4. ECO creation:

Once the ECR is approved, an engineering change order (ECO) is generated, which lists the items, assemblies and documentation being changed and includes any updated drawings, CAD files, standard operating procedures (SOPs) or manufacturing work instructions (MWIs) required to make a decision about the change.

5. ECO review: The ECO is then circulated to a change review board made up of all stakeholders (including external partners when appropriate) who need to approve the change.

6. ECN circulation:

Once the ECO has been approved, an engineering change notification/notice (ECN) is sent to affected individuals to let them know that the ECO has been approved and the change should now be implemented.

7. Change implementation:

Those responsible for implementation use the information in the ECO and ECN to make the requested change. While an engineering change order is used for changes that are executed by engineering, other types of change orders may be used by other departments. These include the:

• Manufacturing change order (MCO) — A change order describing modifications to the manufacturing process or equipment.

• Document change order (DCO) — A change order detailing modifications to documents, specifications or SOPs.

ECO benefits

While you may groan at the prospect of pulling together another set of documentation, an ECO is a critical part of keeping product development on track and making sure product information is accurate. A good ECO contains the full description, analysis, cost and impact of a change, and a good ECO process ensures that all stakeholders have bought in to the change. Having an organized method of handling product changes reduces potential design, manufacturing and inventory errors, minimizes development delays and makes it easy to get input from different departments, key suppliers and contract manufacturers.

Following good ECO practices also makes it easy to document a full history of what changes have been made to a product and when they occurred. In industries with regulatory requirements, like the medical device industry, having a full history of every change to a product is mandatory. Depending on the industry, change orders and even the change process itself may be audited by a regulatory body. Keeping a record of product changes will also help you debug any problems that occur after your product launches. The task of identifying and fixing the root cause of any problem is easier when you have a complete product change history.

Without a clear ECO process in place, making a change to a product can set off a chain of costly, time-consuming and avoidable events. Take a part switch that happens late in the development process. Engineering may tell manufacturing to be aware of the new part, but if that information is never conveyed to the purchasing department, the old part will be ordered. When the components arrive, manufacturing will not be able to assemble the product, and its launch will be delayed until the new part is obtained (most likely with some rush charges incurred along the way).

Engineering change orders make it possible to accurately identify, address and implement product changes while keeping all key stakeholders in the loop and maintaining a historical record of your product. Without them, miscommunications occur that lead to delays, incorrect purchase orders and improper product builds.

Companies need to be able to adapt quickly in today’s constantly changing environment, and often that means making changes to their products. Engineers make modifications during development and production with the intent of adding functionality, improving manufacturing performance or addressing the availability of a particular part.

To make sure proposed changes are appropriately reviewed, a solid process is critical, especially if members of your product team are scattered across multiple locations (for instance, design engineers in Boston, the manufacturing team in St. Louis and component manufacturers all over the world). At the heart of a solid change process is the engineering change order.

Engineering Change Orders: Paper-Based vs. Electronic Documentation Systems

	Managing Paper ECO	Managing Electronic ECO
Cycle Time	·         ECO is generally reviewed one person at a time. ·         If multiple copies are distributed, edits must be consolidated and reviewed again. ·         Paper ECO can be misplaced ECO review can be a long process (weeks).	·         ECO can be reviewed by many people  at  once. ·         All edits are made to a single version, so no consolidation is needed. ·         ECO is always available online.ECO review is significantly shorter process (days).
Signature Process	·         Early approvers won’t be aware of edits, necessitating additional rounds of review. ·         Official approval disappears if the ECO file is lost. ·         Harder to maintain clean, complete history of changes.	·         All approvers sign off on the same set of documentation. ·         Electronic signature is 21 CFR part 11 compliant, a requirement for the medical device industry. ·         Automatic maintenance of clean history for audits.
Issue Resolution	·         Individuals need to be tracked down to resolve problems. ·         May need to wait for change control review board meeting to connect with other approvers.	·         People’s comments can be viewed, so hold-ups can be quickly resolved ·         Can easily see who hasn’t signed and request approval electronically.
Package Format	·         Large paper file of documents and drawings must be printed. ·         Tedious and labor-intensive to pull together information from many locations.	·         Electronic documentation is environmentally friendly. ·         Easy to create and access ECO when managed in the same system as underlying product information.