Change control expertise · READY method
Descriptions that are too vague, impacts discovered at implementation, files piling up overdue and blocking release. We bring rigour back where it all happens: the description, the committee assessment and the management, through to closure.
−22 %open change controls in four months, from 866 to 672
109 out of 120overdue change controls closed in three months
85 %of change controls covered by an audit remark closed, when the commitment was 50%Results measured on two sites: a pharmaceutical chemistry site and a production site coming out of an audit.
A poorly described change is a poorly assessed change.The description carries everything: what isn’t in it will be neither assessed nor anticipated.
Describing a change is a skill. Not everyone can do it: the description must be owned by trained people whose role it is.
Not everyone can describe a change. Identified and coached change owners open the change controls, starting with their first files alongside us.
change ownerscoaching
What is changing, what is affected, who to involve: an opening form and a “change or no change” decision-support tool frame the description from the start.
opening formdecision support
Prepared through pre-reading, the committee answers three questions: what does the change affect (impacts), what must be anticipated during implementation (risks), what will it require (effort). Then it decides go or no go.
committeeimpacts, risks, effort
The assessment sets the type of change (major, minor, or not a change) and a priority from 1 to 4 according to criticality and effort. Each file gets the treatment it deserves, and the most important goes first.
type of changepriority from 1 to 4
Visual management of open items and of each person’s workload plan, in regular check-ins, to unblock files before they become overdue.
visual managementworkload plan
Blocking actions closed before implementation is authorised, synchronisation with release, communication to customers, then effectiveness review and closure.
blocking actionseffectiveness review
After deviations, CAPA and release, change control remained the blocking process. Visual management shared by both entities and system quality assurance.
Three days of workshops to redefine the process, then two pilot areas: a filter before opening, writing rules, a team of experts to assess impacts and weekly visual management.
An audit remark about change controls open for too long. File-by-file follow-up, with each person involved, through to final signature and closure.
Analysis of data extracts and interviews with the people involved to understand your real process, then feedback on the blockers.
Flow, roles and responsibilities, opening form, committee charter: your decisions, made in workshops with the decision-makers.
Opening the first change controls with your change owners, and attending the first committees to challenge decisions.
Visual management launched and run with you, then coaching of your internal lead and remote follow-up to keep the momentum.
The Effective Quality Brigade helps clear a backlog: descriptions, committee preparation, action follow-up.
with the Effective Quality BrigadeIt’s the process that governs any modification to a process, equipment, supplier, document or system that may affect product quality. It ensures that every change is described, assessed, approved, implemented and verified.
Because everything else follows from it: a poorly described change is poorly assessed, its impacts are discovered too late and its actions are poorly sized. Describing a change is a skill, entrusted to trained change owners.
In a multidisciplinary committee, along three lines: impacts (what the change affects), risks (what must be anticipated during implementation) and the effort required. This assessment is used to calibrate the type of change and its priority.
By managing them in two stages: up to approval for execution, then during implementation, with a view of open items, each person’s workload plan and the blocking actions to be closed before implementation.
Yes: the Effective Quality Brigade can reinforce your teams, write descriptions, prepare committees or move actions forward, using the same method.
Tell us about your situation in thirty minutes. We’ll tell you where time is lost in your process.