 |
ISO
Documentation - Prioritizing
|
Documentation
doesn't just happen. While it would be nice if the documentation could
magically be updated - in reality this just doesn't happen. Documentation
requires a certain amount of attention and focus. Here are a few tips
to keep your documentation on target and prioritized for your department.
When are documents reviewed?
- Business
Change
- one time to review and update departmental documentation is anytime
something in the process or business changes. Over time there are quite
a few things (maybe subtle) that change, whether we a new software program
is implemented, a vendor or distributor changes for a particular part
of the business or the department changes the roles and responsibilities
of employees within the department. When business changes occur, reviewing
processes and procedures keeps the documentation current with these
business changes.
Bi- Annually - Our quality system requires a regular
review of documentation - every two years. When a document has not
been updated in the past two years, this initiates a red - flag to
review the process and make sure the documentation is correct and
functional for your business. Even if there have not been business
changes, chances are there have been other updates that need to be
reflected in the documentation. Keeping the departmental focus on
reviewing all external and internal documents every two years will
keep the department current with the our policy for regular review
of the documentation.
(Top)
What else triggers reviews
of documentation?
- Audits:
Departmental, Quality and Registrar (BSI).
There are three types of audits and each audit can trigger required
updates to documentation.
The departmental audit
is an ongoing review of the department's process, procedures and business.
The departmental review is an internal review of process, performance
improvement and attention to the goals and business. Departmental
review is conducted informally by the management and the employees
affecting quality. When gaps in performance or process are discovered,
updates to the process and documentation are generated to close the
gap.
The Quality Audit is an internal
audit conducted by the quality audit team. The quality audit team
is comprised of employees from all departments who are assigned areas
to audit within the company. This team visits each area annually and
reviews the department for compliance to the ISO Standard. During
this review there may be noted areas of improvement, some of which
may include the update to documentation and or quality. When quality
audits are conducted corrective and preventive actions are identified.
Many corrective and preventive actions require updates or changes
to existing documentation.
The Registrar (BSI) audit
is semi- annually. In order for us to continue with the existing certification,
the company must prove the quality system is performing to the standard.
Departments are audited by the assigned auditor and areas of improvement
are identified. These items are reviewed during the next audit and
require the department to take action to close the item using the
corrective and preventive action process. Documentation is usually
updated as a part of the corrective action, although some items will
never change process or procedures and do not require documentation
changes. The auditor works with employees and management to identify
areas of improvement during the audit and provides feedback to the
auditees for performance improvement and quality improvement.
- Training
- Departments are required to keep current training for employees affecting
quality. Training can reveal shortcomings in the procedures and help
the department to improve the process or procedure to be more complete
or accurate. Training can also reveal weaknesses in areas that are not
fully identified or documented, requiring that additional process and
procedures are created to improve the quality system. Managers and supervisors
have the responsibility to assure training is being conducted on a regular
basis according to the departmental training plan and the employee performance
improvement training plan. Managing training for the department and
the employee provides opportunities within the department to improve
the quality of the performance and reduce the inefficiencies. Some residual
changes to improvement may include updates to the existing process and
procedures.
- Management
Review - Departments are responsible
for initiating regular review of their business for opportunities to
improve. Many changes in the business may be subtle, like changing how
information is communicated within the department. Other changes require
a refocusing of priorities and a significant change to the way business
is conducted. The opportunity to plan for performance improvement and
managing quality occurs at the departmental level. Management defines
how to improve performance, and quality for their areas. Within this
scope of responsibility management also assures the documentation is
accurate and current for their business and guides employees to assure
the accuracy of the documentation is effective for their areas. Documentation
as a consequence of Management Review is updated to reflect the current
business process and procedures.
(Top)
Corrective
and Preventive Action - When a corrective or preventive action
is initiated within the department or as a result of an audit, documentation
may be part of the solution for resolving the issue. Generally, the
responsible department will identify the root cause and ways to prevent
the problem in the future. The actions the department will take are
documented in the Corrective Action System, whether this is the Quality
System, or the departmental corrective and preventive action process.
When the manager is identifying ways to resolve the item, documentation
may be one of the resolutions to the identified problem.
|
