Having an ISO / QS
certification gives you the right to LOSE it every 6 months! This is
a rather drastic evaluation, but quite frankly, a realistic one.
Maintaining the rigid quality system standards established by the
international committee dictates periodic re-evaluation of a
company's adherence to those standards.
Simply stated, the
philosophy behind ISO is:
Say what you Do
- Document Standard Operating Procedures (SOPs)
Do what you Say
- Adhere to these SOPs
Prove It -
Document the two previous statements!
Those of us in the
manufacturing sector have become familiar with the requirements of
managing and maintaining our portion of the ISO / QS certification
for our business. ISO standards management for maintenance-related
functions can be accomplished in your Computerized Maintenance
Management System (CMMS) with very little additional work on your
part.
WCI Steel began a
program of computerized management of its assets, maintenance
responsibilities, inventory, labor force, and preventive maintenance
in 1990, selecting
MAPCON® over a host of other products. This report examines the
solutions our CMMS provided in maintaining an ISO/QS-9000/2
certification.
Say what you Do:
An existing table in the
software provided an excellent vehicle for creating and editing the
control processes for our maintenance environment. Standard
Operating Procedures (SOP's) for both Maintenance and Operating can
be developed. The W Y S I W Y G format was compatible with "cut &
paste" features of Windows. We are also able to attach detailed
schematics, diagrams, - even photos to aid in the safe completion of
a repair. Supplementing this is an Import/Export feature that can be
employed with existing files in other systems. Either way, you gain
several significant advantages by managing these records in a
plant-wide, CMMS as opposed to other established processes:
Plant-wide, on-screen
access to Procedures:
Many companies manage
their SOP's via the department secretary / clerk who keeps the
records on their PC or saved to a network drive. The files are
restricted to one or two employees for security purposes. Copies of
the most current revision are made and distributed throughout the
plant or department, and placed in "books" for ready access and
review. Since out-dated information is a definite non-compliance
issue in ISO / QS management, procedures have to be developed to
define the handling of the old copies removed from each book.
Folders, Files, Storage Cabinets - all these steps require
dedicated, labor intensive management to ensure conformity.
A multi-leveled security
system in a CMMS provides the same control features to create / edit
records, plus allows on-screen viewing of the most up-to-date
changes to procedures anywhere in the plant. All this happens within
seconds after the changes are made! No more need to make,
distribute, retrieve and manage copies of your procedures.
By managing SOP's in a
CMMS, there are no out-dated, obsolete issues to address; the most
current revision is the one displayed. Browse screens or
screen-editing security guarantee the integrity of the data.
Not all Procedures
are ISO procedures:
The ability to customize
screens and menus in a CMMS is a valuable tool in the management of
ISO/QS procedures. By creating a new dictionary item in the file,
it’s possible to add a BOOLEAN-formatted field, and place it on the
screen as a "required" entry. You're now able to list all ISO and
non ISO-related procedures via ad-hoc reporting features. Build
yourself a new look-up, and you can sort the records according to
their Y/N ISO "flag". Hands-on users can quickly find appropriate
procedures when needed for review, or as part of an audit.
Job Safety Analysis (JSA)
management:
In most manufacturing
environments, Safety Procedures are defined for virtually every
maintenance function performed. Documentation of these procedures
provides valuable assurance that the job gets done safely and
correctly. In many cases, these procedures are a matter of law, and
routine discussion with employees is part of an effective safety
program.
Whether they're called
JSA's or Safe Maintenance Procedures or Job Tasks, they all
basically outline the step-by-step procedures required to safely and
correctly do the job. These procedures are the basis for many ISO/QS
procedures for maintaining equipment.
As with corporate or
departmental ISO procedures mentioned on the previous page, JSA's
are commonly managed in one location by one or two employees for
security purposes.
The same benefits can be
reaped from a full-functioned CMMS as well; W Y S I W Y G format,
plantwide access via PC's connected to your network, Create / Edit
security, current information. Safety Procedures can be attached to
Equipment records, or to PM routines as well. When Work Orders for
the equipment are generated, you have the ability to print a copy of
the Safety Procedure(s) as part of the job.
Identification of
ISO-critical Equipment:
A basic requirement of
ISO/QS certification is the identification of those pieces of
equipment in your facility that have "a direct impact on the quality
of the product". If employees don't know which pieces of equipment
impact the quality of your product, it's doubtful that you'll be
able to maintain it to provide consistent quality. Once again,
computerized maintenance software provides a solution.
As mentioned earlier,
one of the strengths of some CMMS programs is giving the user the
ability to customize the program to meet their needs. Coupled with a
responsive support service from the developer, user-defined fields
can be added to data entry screens. A required "checkbox" or Y/N
entry enables a company to answer the question "What ISO-Critical
equipment am I responsible for?" The graphic below demonstrates this
problem-solving feature.

"Qualified"
Maintenance:
Once an organization
identifies which equipment is ISO-critical, the next phase of the
process is developed. Who is responsible for maintaining the
equipment, and the skills required to do so need to be addressed.
Human Resources, Craft Codes, and other integrated modules provide
the solution.
Craft Codes are defined
in the program, and Employee records are entered in a Human
Resources file. By defining specific Training programs in an
appropriate table, programs can be attached to individual employee
records - either through Timecard screens, or directly from the
Human Resources table. Entries made via the Timecard system should
automatically update the H/R record to show attendance at Training
sessions. Again, the reporting features throughout your software
provide you with the tools to respond favorably to an audit.
Managing Critical
Spares:
Its not enough to know
which equipment is critical, who will maintain it, and what skills
are required. Reality tells us that nothing lasts forever, and parts
eventually wear out. Keeping the equipment on-line means having
critical spare parts available in the event a breakdown occurs. When
this happens, you must ensure that "shortcuts" aren't taken that
will compromise your ability to keep the unit performing efficiently
to maintain product quality.
Inventory tables,
coupled with a Vendor database, provide maintenance organizations
with the tools to ensure they have the right part when needed. Part
status ratings called CR(Critical) or CS (Critical Spare) enable
maintenance groups to manage items in more than one location in the
plant. Or, you can create a single stockroom called "CRITICAL_SPARES"
and group all essential or long lead-time parts there. Reporting
could then reflect your ability to make essential repairs to
critical equipment in a timely fashion.
Do what you Say:
Now that you've
identified WHAT you do, your focus will be turned to the WHO, HOW,
and WHEN aspect of ISO/QS management, or the "Do what you Say" step.
Preventive Maintenance
is the minimum amount of resources required to maintain optimum
equipment performance. Changing the oil and filter in the family SUV
every week - although certainly a benefit for the engine - is hardly
preventive maintenance. The same applies to your gear reducers,
motors, cranes, conveyors and process lines. Every hour spent
maintaining equipment affects profitability. On the other hand,
spending too few hours on maintenance affects your equipment
negatively, and seriously impacts its ability to maintain quality.
That's where Preventive Maintenance (PM) pays off.
The pinnacle of any CMMS
is its PM system. Every other module in the package only serves to
support the PM system. Once the What, Who & How have been
determined, the When becomes the job of the PM module. PM procedures
detail the minimum steps required by the equipment manufacturer to
maintain equipment up-time. The automotive industry's 3 months or
3,000-mile oil change interval is based on "normal" operation.
Likewise, manufacturer's minimum standards for your equipment should
be adjusted accordingly.
QUESTION: When
does a company consider its PM system to be finished?
ANSWER: Never!
Remember the saying -
If you keep on
Doing what you're Doing ,
You'll keep on
Getting what you're Getting.
Once PM procedures have
been developed & tested, it's time to turn the process over to the
PC. Having established the "Date Last Done" for all your equipment
PM's, the computer assumes the responsibility of keeping track of
the next time each maintenance function - or PM - is due. It does
this by issuing a Work Order created from the information on the PM.
Short-circuit this step, and you will certainly jeopardize your
Certification, and lose the "Do What You Say" piece of the process!
Work Orders are
generated from the PM procedures you've written, and assigned to the
appropriate Craft personnel (or defined Crews) for execution. Once
the work has been completed, the work orders are closed, with
supporting comments and details noted. As an organization's work
orders migrate from "reactive" to "proactive", their equipment
up-time increases, and costs ultimately decrease.
As mentioned earlier in
this report, JSA's or Safety Procedures can be attached to a PM that
further detail the maintenance work required to safely keep the
equipment running. Having a system that allows the user to draw
information from several sources - without the need to duplicate in
each - is certainly an asset provided by some CMMS packages. This
report started out discussing the ability to create / manage SOP's
in available tables. These records can be easily attached to a PM
procedure without re-typing the information! Further, if changes are
made to the parent document, they will be reflected automatically
the next time a PM they are attached to is generated.
Prove It!:
Developing and managing
all of this information takes the combined efforts of several groups
within an organization. First, a System Manager oversees the
operation of the program and is responsible for the training,
implementation and maintenance of the software. Next, departmental
staff must build the Human Resource information and related Training
programs. The maintenance group must identify and develop the
Equipment and Inventory information essential for successful
management. Finally, a well-informed maintenance crew whose job it
is to keep the equipment running is a must. Each step of these
processes begins to create the documentation that satisfies the
"Prove It" phase of ISO/QS-9000. Reports can be generated that
answer the questions needed to verify compliance.
Since ISO/QS compliance
involves Equipment, Inventory, Training, Maintenance & PM records,
we decided to create a single menu where anyone involved in an audit
could obtain information that demonstrates compliance. It's not
uncommon for an auditor to ask for evidence of Equipment
Identification, Critical Inventory, Employee Training or PM
Compliance records from the person being interviewed. At WCI Steel,
we have created a single menu in our software devoted to the "Prove
It" phase of ISO/QS management. Anyone involved in the audit process
knows how to access this menu. It contains reports or "evidence" of
compliance to the "Do What You Say" phase. The ISO/QS-9000 Reports
Menu in use at WCI Steel is shown on the below:

From this single menu,
the department or individual being interviewed can answer questions
like:
- What equipment is
defined as ISO-critical in this Department?
- Can you show me how
your crew is doing on their PM requirements?
- How may times - and
when - have you completed PM work on Eqp.# xxxxxxxx?
- What are your
Critical Spares?
- Which employees
have been trained in Training program yyyyyyyy?
- What
Quality-related SOPs exist in this department?
- Can you show me a
copy of all the PMs for Eqp. # zzzzzzzz?
- Do you have any
open PM Work Orders for the Millwrights?
Inquiries such as those
listed above involve Equipment, Inventory, Human Resources, Work
Orders and PMs. By consolidating all the reports to one menu, users
don't have to know the layout of every report menu in the software,
or determine if certain information is available from one section of
the program instead of another. Our software allows us to create not
only the reports that we need, but our own menus to display them
from as well.