How adequate training helps control product-maiming contamination
Untrained cleanroom personnel can make or break a product manufacturing operation by introducing contaminants to the process
By Tony Waring
Very few of us are blessed with an inbred understanding of quality — anything that is precisely fit for its intended use.
In reality, achieving quality is indivisible from training. This applies specifically when manufacturing sensitive products because product-specific intrinsic procedures must be followed as well as additional disciplines to control product-maiming contamination.
Understanding and accepting training varies widely from manager to manager. To some, training interferes with the real work of the enterprise while to others it is the engine that drives the performance and profitability of the company which, whether we like it or not, is why we are employed. Sometimes upper management asks for better quality; demands lower costs; requests more volume or suggests that the training budget should be trimmed.
This scenario was played out recently by the manager for performance improvement (also known as the head of training) for one of the largest international corporations in its field. The manager wrote, “Unfortunately, from experience, I suggest that when discussing training you really must cover the politics of the subject because most senior level managers still hold little regard for the subject and consider it an evil necessity. They rarely consider it a business need.”
These comments vividly reminded me of a recent project where the benefits of training had completely escaped the top level managers who were perhaps under too much pressure to remember that good management is the skill of translating good policy into good practice. Therefore, this column is a case-study of Company XYZ whose products are made in cleanrooms but where contamination was not under control. The names have been changed but the facts have not.
The benefits of training
Training is easy to define. It is the process by which we teach specific skills and achieve physical and/or mental efficiency. It produces both tangible and intangible benefits. It may involve better compliance to industrial/state/government regulations or better utilization of plant and equipment and a more effective use of materials.
Company XYZ
Tangible results can be measured and quantified. Company XYZ makes “widgets” which sell at an average [post-downsizing] market-competitive price of $17.45 each. They are produced in cleanrooms using materials sourced from 11 vendors with a total materials cost of $7.50 per unit. Historic yield is 70 percent after reworking, or 700 salable widgets for every batch of 1,000 started. The total manufacturing and materials costs of each salable widget is $14.28 giving a gross margin of $3.17 or 18.2 percent before deducting R&D, marketing and sales costs in addition to overhead and profit contribution.
Company XYZ`s new CEO tells his executive team that the firm is marginally viable at this level, and as his first step, he`s looking for a substantial performance improvement. The Vice President of Sales doesn`t need his calculator to know that, in theory, a price increase goes straight to the bottom line.
The Materials Management Vice President knows a 5 percent cost reduction to bought-in materials will add 37.5 cents, or 2 percent, to the gross margin but she is equally aware that part of the problem with the yield program is due to the failure of outsourced materials.
Meanwhile, the new Production Vice President, knows that the recently introduced training program promises a 30 percent improvement to the gross margin over the next three months. How will it be done?
The objective
The inherited yield means that 300 widgets out of each 1,000 started are being scrapped despite having incurred 100 percent of the costs of a salable version. The objective is to improve yield from 70 percent to not less than 75 percent thereby reducing the net cost of every salable unit by 95 cents (to $13.33) so increasing the unit gross margin by 30 percent to $4.12.
Developing the program
The first step is to recognize that a problem exists. Next, stand back and start thinking of the problem, not as one problem, but as a series of items or processes which may have one or more intrinsic problem(s) which combine into a very unpleasant whole.
Problem solving always benefits from the building block approach and the development of training programs is no different. In our case study, the first step was to accept that a [yield] problem existed and to analyze everything, factor by factor, to see where training would improve performance. The project was broken down into elements from which the following emerged:
Design. The new CAD system had been installed when a re-design was in progress and several members of the design team were not fully trained on the conversion. In addition, there was no requirement for them to be trained in assembly technique and ease of assembly was not a critical item on their agenda.
Training needs: Establish full formal training on the CAD system for all design staff plus practical training in assembly to ensure best design practices.
Specifications. Several people had issued specifications without cross verification. Variations in their approach allowed vendors and internal staff to freely interpret the specs.
Training needs: Establish a new system and train all design and development staff to adopt it. Quality system training and retraining should be mandated for all staff.
Materials. All 11 vendors delivered materials via their own interpretations and standards.
Training needs: Establish better working relationships and training programs with and between vendors and the company.
Contamination control. Cleanrooms present multiple opportunities for inadequate operations. Not only did the cleanroom have areas of turbulence through equipment siting but also cleaning procedures were not properly specified and incorrect materials were in use. Monitoring was done on a random basis.
Cleanroom personnel had developed bad habits in both behavior and gowning not to mention the design team`s lack of training, which had led to contamination-creating components and assembly procedures.
Training needs: Establish fundamental training and re-training to be undertaken of all cleaning, operational and support staff based on new training manuals.
Procedures. Evidence from all other elements suggested weaknesses in the development of existing Standard Operating Procedures (SOPs) highlighted by assembly and operational procedures.
Training needs: Establish new procedures for SOP development and apply technical writing training to managers and staff.
Maintenance. When trying to work through the problems, management had put maintenance — never a high priority — onto a back burner. Meanwhile virtually no maintenance, other than repairing failures, had been done. The plant was audited as being below 60 percent in plant and equipment operational efficiency.
Training needs: Establish new training procedures and train maintenance staff to be familiar with other disciplines.
Quality assurance. In reality, this department performed quality control by checking materials and post-assembly work rather than creating proactive quality attitudes and learn protocols across the company.
Training needs: Complete training in quality systems and learn how to train others in these systems.
Training. One professional trainer had been expected to undertake all training responsibility including administration, course development and instruction. This in an environment where training was treated as an interruption to the real job.
Training needs: Re-allocate the trainer`s duties. The trainer could and should be treated as the in-house training consultant by working with administration and operational management to develop appropriate training programs and associated manuals.
Conclusion
Company XYZ`s training analysis and development program was complete, and the Production Vice President knew that a 5 percent yield improvement could be achieved. In fact, they were really looking for closer to a 15 percent improvement due to other products in the pipeline.
In summary, training is now a central aspect of the business plan, tangible benefits are being realized and there is an air of self-fulfilling confidence.
There are a few organizations where quality and performance can`t be improved, usually because everyone is far too busy. Even if we`re not blessed with it, most people can achieve an understanding of quality but some must still have it thrust upon them.
Tony Waring trained as an engineer but in recent years has specialized in personnel-related contamination control involving cleanroom design and management and, specifically, quality management and training to cGMP-regulated industries as well as to microelectronics, precision manufacturing and service industries. In 1991, he founded Micron Video International (Hampshire, England), which produces, publishes and markets video-based multimedia training to those industries in 85 countries.