Maintenance in an Outsourced and Regulated Environment
Maintenance was long seen as a Cinderella activity. However, analyses in the process industry as a whole showed that whereas the value of a capital saving on a project could be measured in a once off saving of millions, the cost year on year of ineffective asset maintenance was compounded and could reduce or negate the planned return on the capital invested. So, over recent years, more and more intellectual effort has gone into the maintenance processes.
The first thing to get into the mind is that we are not maintaining assets. We are aiming to maintain a given functionality, sufficient for its purpose, not more and certainly not less. This infers measurement, a topic to which we shall return.
The next fact of life is to recognise is that in common with many industries the maintenance work is being outsourced. Whilst the merits of this can be a highly debatable topic in itself, the main message is that it is not an excuse for the company’s own engineers to abdicate responsibility. Quite the reverse. Indeed, they must be precise as to what they want in order to meet the desired (measured) operational performance and regulatory needs for compliance. Allied to the progressive achievement of cost reductions for the facility owner and acceptable margins for the outsource service provider.
Foundations
So how is all this to be achieved? Like any structure it needs firm foundations, what are the principles on which we should build.
A thorough understanding of the applicable Regulations and their interpretation is an essential. This is not simple and indeed most of the major industries’ players have people whose entire role is to keep up with the burgeoning regulations and their interpretation. Not that we disagree with the intent of the regulation. For example, they are there to ensure our safety from explosion, long-term health issues and efficacy when we are prescribed drugs in a personal fight against an illness. Like today’s hot topic of air travel security, I do not mind intensive searches applied to all, as it makes us all safer and from the regulators point of view, just one incident is regarded as their lapse.
Pharmaceutical Regulations are based on the impact of the asset functionality on the consumed drug. The solution to this problem is the progressive assessment of what the intended functionality is followed by a rigorous review of its design, the system manufacture, and installation and testing. All these steps being thoroughly documented and open to review by many auditors, both internal and external to the parties directly concerned.
Next you must have a maintenance team. A team, which must allow open discussion. No one should be afraid of his or her suggestion attracting ridicule or aggressive confrontation. Openness is easier said than done in what are multi-discipline and increasingly multi-organisational teams.
Finally, there must be measurement. Measurements can initially be very crude and then progressively made more meaningful as the team’s understanding grows and performance develops. Measurement also implies information. Information has a key role in achieving business goals of compliance, profit, and survival, which are the objective(s) of the considerable effort involved.
Team Building
Having taken part in “open and frank” discussion sessions until the early hours and in “outward bound schools”, I know that there are many ways that are said to breakdown barriers and build teams. Some may result in more of the breakdown than those involved with the maintenance process would wish to hear. However, the work is for a specialist and one should find a good specialist consultant, examine their records with similar clients to you and then work with him or her.
Overall, any team building process must include the organisation from the top. Most of these training methodologies have a language of their own and shorthand descriptors of “missionary” or “mover/shaker”, need to be understood by all and seen for what they are, intended as constructive and not a snide, back of hand, remark.
The consultant will have a methodology that they have developed. All course programmes are unique because your current team and where you would like to take them are unique. The route between the starting point and the initial destination (sorry folks, once you have got near the first goal, your medium-term targets will have moved!) will use components of the consultant’s toolbox, perhaps in varying sequences. And it will not be quick. Most teams will have a core of people who have been involved for years. Their working rules could have been very prescriptive or even very vague, but usually demanded conformance and not requiring individual, spontaneous change. Now suddenly the rules of the game are all changed. We all know that with people this is not a rapid process. There will be surprises, some wallflowers will become a rose and there will be casualties. Be prepared to despatch them with sympathy and generosity or risk the team’s reactions being negative, even hostile, and so causing the consultant’s fees and your team players time so far to be wasted.
Measurement and Methodology
The adage “if you cannot measure it, you cannot improve it” is simple and broadly true. Whereas you may feel performance is now better, how do you get the doubters to agree? There can be many measures. Equipment availability, product throughput, product in or out of spec. operator hours per product batch, maintainers costs, etc. Deciding which are right could form good team exercises in the later stages of their development. Also, the interpretation of the measures related to time periods. The development of measurements of Key Performance Indicators (KPIs) over time will become a role of management.
Successful measures should be simple to collect, be easily understood and show a trend reasonably quickly. However, the disappointment is that “quickly” may well be a minimum of six months and often much longer. Although measures can be collected by any time period from a minute to a month, they are frequently distorted by exceptions, so one needs time to even out these exceptions, if each statistical report is not to be covered in caveats, a feature that tends to strengthen the doubters of the whole process of process development in the maintenance arena. The high-level measures, such as cost of maintenance per £1m of installed capital can only come into their own when two complete years’ figures have been graphed.
And there is that most important measure of all – cost! It is always important to the accountants and should be part of the annual performance criteria for every manager, as money is not unlimited.
We have been involved through the methods outlined below in creating an outsourced contractual environment where every maintenance activity is defined in its work content to the contractor and to the customer through a Service Level Agreement (SLA). Then when frequencies are changed, the result is a seemingly incongruous, infinitely variable fixed price contract.
More focussed data needs to be based on the methodology adopted to plan maintenance. Reliability Centred Maintenance (RCM) is a major methodology in this area. It was developed in the late ‘60’s and ‘70’s to tackle reliability problems in the commercial aircraft business. Here again as with the pharmaceutical industry, the public’s safety; regulations to achieve that goal and the operational economics are intimately intertwined.
The basic question of the application of RCM is “what function(s) does the system/equipment perform”. This can be dealt with holistically and for each subset of components. Remember it was said earlier that we do not maintain assets, but functions. The understanding of the regulations makes it clear that some functions are vital for safety, (an issue to all engineers), business needs to produce enough product at the right cost and process needs to produce the correct quality of product and keep regulators off the company’s back.
Safety is a paramount issue to all engineers and involves a clear understanding of the risks involved. Often and tragically the envelop of this understanding is extended by an accident, e.g., Pipe Alpha in the North Sea oilfields and in the pharmaceutical context, Thalidomide. The business need also needs an assessment of risk as well as a possible change of culture. The philosophy of avoiding the stigma of a breakdown is engrained on many maintenance cultures. It was perhaps the Americans who coined the phrase, “if it isn’t broke, don’t fix it”. Yet the bicycle shed culture means that unimportant items stopping in an unscheduled manner destroys hard won reputations and traditional wisdom says that such must be avoided at all costs. Not so. If the extraction fan in the gent’s loo breaks it is cheaper to buy a new one and it can still be done that day.
As far as the regulations are concerned, the UK rail industry is shackled by the fear of another fatality and the whole pharmaceutical industry lives in dread of a Regulatory Citation. There are websites devoted to proclaiming them. It also seems that the threshold of acceptance keeps rising as the worst performers are pushed out or up to the average performance and the average are spurred to emulate the best. Still as we say, the prize is our family’s safety, and it is our challenge as engineers.
We are a long way from the “no blame” culture paramount in the sphere of airline safety.
Information
It is now commonly accepted that discreet products, your car, and complex process facilities have a cradle to grave lifecycle and their information processes in terms of data creation and what is needed follows and varies with that lifecycle.
Too often there remain discontinuities on what is created during a project with an owner’s project manager using one set of contractors and the owner’s operations manager’s needs when using another set of outsourced contractors. There is a loss of data integrity, especially in the area of “as built” compared with “as designed” in this traditional environment. The oil industry has gone a long way in bridging this gap by contracting the original main contractor to design, build and then operate the facility and be paid for the delivered product to agreed production schedules. This is not so much and abdication of maintenance responsibility - but divorce!
However, the very work that led to this revolution was the recognition that Exploration, Development, Production and Marketing were all approximately equal in terms of their demands on the corporate resource. The second key point was that the oil company's core business, in which they had to excel in to survive, was Exploration and Marketing. Thus, the result a sensible integration of the design, construction, and operational responsibilities, so that there is every advantage in ensuring the retention and availability of the information collected throughout the facilities life. Our research has shown that the most demanding information needs are those of the CDM (Construction, Design & Management) regulations needed when the time to decommission and dismantle arrives.
The pharmaceutical industry is not alone when faced with collecting, storing securely, and retrieving vast amounts if detailed information on every operational action that the regulator may regard as important.
- Was the line operating within the correct limits for the product at 12:32 on 19 January last?
- Were the instruments that recorded this “fact”, within their valid maintenance period?
- When they were last maintained, were the calibration instruments with their valid period?
- Was the operative who did the work correctly trained?
- Was his/her trainer, trained?
- Was the calibration instrument calibrator licensed?
A paper chase indeed and yet the escape of electronic collection is fraught. Arguably it is just technically achievable, but therefore still expensive. But like the “paperless” office of dreams, total avoidance of paper is difficult and leads one into the area of electronic records and electronic signatures (ER/ES) that could even tax the authentication and non-repudiation technologies of the military. Fortunately, there changes underway from purely prescriptive control to risk-based assessments.
Norman Harris is an independent consultant specialising in Information Management Strategies. Former Chair of the Pharmaceutical Committee and Past Chair of the Process Division of the Institution of Mechanical Engineers.