More than 2,500 years ago, the Greek philosopher Heraclitus said, “The only thing that is constant is change.” That’s true in life—and also in product manufacturing. Though change is a regular occurrence, at CPC we methodically and systematically manage it to maintain consistent product quality.
A Quality Management System (QMS) specifies the “one right way” for us to perform our work. Defined policies and procedures detail how we develop, manufacture, distribute and support products and services. We also adhere to industry Quality System Standards (ISO 9001 and 13485).
That said, changes happen in both products and the quality systems that govern them. Customers, suppliers or CPC can initiate change, which then must be approached in a highly controlled manner to achieve the desired results and avoid negative outcomes. That’s “change control.”
Documents define how we work
QMS procedures and documents form the basis for our actions. The Quality Manual defines CPC’s compliance policies related to ISO 9001 & 13485. Standard Operating Procedures (SOPs) articulate QMS processes around new product development, validation, complaint handling and other areas. Work instructions detail the specific steps required to manufacture finished goods, perform preventive maintenance on equipment, or inspect an incoming part. Other forms, records and blueprints fall under QMS, too.
Changes in any of these mission critical documents are entered into robust software that manages the change process through a series of reviews and approvals. The system captures and prompts actions from initiating a change request to obtaining stakeholder feedback to final document approval. A procedure only works, though, when people follow it. We track training to ensure CPC staff is both aware of, and thoroughly trained on, new and changed QMS procedures and documents.
Product changes are usually heavily specification driven
CPC products are the result of complex engineering specifications, material requirements and process controls validated to deliver reliable performance for our customers’ applications. But what if CPC, a customer or supplier changes something?
Maybe a customer wants different materials for cost, availability or performance reasons. Perhaps a supplier deploys a new tool. Modifications to a custom product affect the blueprint or tolerances.
Changes occur for a wide variety of reasons, but each alteration can trigger another, whether intended or unintended. For example, changes to specifications or tolerances could potentially affect a connector’s sealing characteristics or flow rates. Changes to materials could impact the strength of welds or react unfavorably with customer media. To best manage these variables, CPC is diligent and systematic in defining change, assessing risk and impact, proposing actions and then conducting validation and verification testing.
SOPs and work instructions facilitate change on the manufacturing floor
Change gets “real” when it moves from concept to implementation. That’s where SOPs and work instructions come into play. By the time a new material or process is ready to incorporate the change, the associated SOPs are detailed and well documented.
On the manufacturing floor, for example, there must be valid, defined and approved reasons for making changes to equipment or deviating from work instructions. No one wants a wrench thrown into the works, literally or figuratively. Again, well defined processes and systems reduce variability, streamline production and enhance quality.
Methodical about managing change
Change happens and CPC does extensive work up front to understand and plan for its implications. All change control systems generally include the name/department of those originating the change request; a reasonably detailed definition of the change; a risk or impact assessment; evaluation of the change; proposed implementation action(s); and final review and approval. These seemingly simple but critical steps help us deliver consistent, expected and reproducible product results within acceptable parameters.
To end with another, more recent quote: “There is nothing wrong with change...if it is in the right direction” (Winston Churchill). We agree—especially if it’s properly controlled, documented and deployed through rigorous QMS policies and systems.