The launch of the new business is looming much closer at the end of the year. All the planning we’ve been doing is coming together and now with just 5 months to go there is still a lot of work to be done.
Development on hosted solutions is progressing and the desktop client will hopefully soon reach beta status. This is all part of our automation of our QMS Fulfilment procedure. Once automated, compliance will be even easier. Maybe too easy! ;O) With the ability to scale quality management activities up and down by simply turning them on or off. All with a real time compliance scorecard.
It is a very exciting time for us and we are now actively looking for forward thinking businesses who seek GMP certification who would like to be part of our journey to launch. You will receive special consideration in terms of pricing and project delivery.
Email to firstname.lastname@example.org if you would like to find out more about how your business can become GMP compliant in the shortest time possible and at minimum cost. Guaranteed!
Read this in a business context…
If you break down a system into it’s component parts, maximise the efficiency of each one, then reassemble the components, you will have the most efficient whole system.
TRUE or FALSE?
Auditing is a very subjective task. Professional third party companies and government regulatory bodies provide training and coaching to auditors in an attempt to achieve a consistent level of assessment across their entire team.
When you consider the approval rate of judges handing out prisoner paroles can change from 34% before lunch to 67% after lunch it becomes apparent that it is pretty much impossible for human beings to be “objective”.
What auditors actually focus on is heavily based on their individual training, experience, personal interests and level of understanding, not to mention their survival instincts.
These things are all determined by the “journey” of their lives and their career within the industry. Did they ever have opportunity to work with sterile products? How close were they involved in production operations? Have they ever actually performed a proper risk assessment in an operational business? What about a root cause analysis for a niggling production problem? Were they ever part of a project team to introduce a new production process or to design and build an entirely new facility? Have they worked in an operating QC laboratory? Have they ever personally written a computer program? Have they designed and implemented an automated piece of machinery?
Maybe the auditor had those opportunities and maybe they didn’t. Luck plays a much more significant role in our professional careers and in our lives than we are prepared to admit. Have you ever considered that luck could have something to do with your knowledge, experience, perceptions, assumptions and beliefs?
Some auditors are from a science background but when it comes to design and engineering they have little (and sometimes no) knowledge or experience.
Conversely, auditors from a technology implementation background often do not understand the fundamental science or chemistry they are implementing beyond the physical properties of the materials to be handled.
The audit assessment and report you receive will be heavily influenced by these things, as well as your lunch menu.
This famous and profound essay comes to mind http://en.wikisource.org/wiki/I,_Pencil.
Forgetting about international guidance documents and quality frameworks for a moment, what are the objectives of real people when they conduct an audit?
Objective Number 1 – Don’t embarrass yourself
As an auditor you have been put forward as an expert in your field. Of course you must be, mustn’t you? To be an expert on everything is preposterous, but how can you check on somebody else unless you firstly “know” yourself?
When your knowledge is slight, how do you know what to look for? It’s one thing to see what’s there that shouldn’t be. What about detecting what’s not there that should be? That’s much harder due to “absence blindness”.
Fact is, if you don’t know too much about something you are unable to penetrate the subject very deeply at all.
How to use this information if you are focused on compliance: Before the audit, request the auditor’s CV so you know which knowledge domains are their strengths and which are their weaknesses. Focus any preparation activities on their stronger areas. If you are confident you are okay in areas which you know they are weak in, stand firm and be prepared to call the auditor’s bluff, safe in the knowledge that the auditor is bluffing too. Sound confident in your explanations and be as technical as possible.
How to use this information if you are focused on quality: As much as possible, focus attention and maximize time on those parts of your business within the auditor’s areas of expertise. Use their knowledge and experience in their stronger areas to identify further opportunities for improvement. Ask questions about things that have always bugged you. The auditor will be happy to share their expertise and appreciative of your genuine desire to improve. Next audit, request an auditor with different knowledge and experience to focus on improving those parts of your business. Beware of auditors who recommend adding over the top complexity in your business systems. This could be a sign of reduced knowledge or experience in those areas.
Objective Number 2 – Make Friends
Leading on from Objective 1 above, and leading into Objective 5 below, it is not in the auditor’s interest for the mood of the audit to become unfriendly. A confrontation may expose weaknesses in the auditor’s knowledge and experience and be quite embarrassing.
How to use this information if you are focused on compliance: Be firm on your approach where you feel you can defend it, even if the auditor’s opinion differs. If the auditor is insistent then politely request the regulatory reference (the regulation and clause number) they are referring to. Maintain eye contact and raise your eyebrows to show non-aggressive, genuine interest. If they are going on their “opinion” they will quickly drop the issue to avoid a confrontation and to keep the audit “friendly”. If they can provide you a specific reference then record it with enthusiasm and move on.
How to use this information if you are focused on quality: It is best to have an open mind and accept that most auditors genuinely believe they are doing “good” in the industry and genuinely wish to use their knowledge and experience to help you do better. If you can accept that then you should also try to accept that the auditor has identified an opportunity for you to examine the assumptions you are making in your business. Perhaps your approach is founded on invalid assumptions? Be mindful of the auditor’s limitations, but trust that they are genuinely motivated.
Objective Number 3 – Cover the Entire Agenda
Auditors have an agenda they need to cover in the allotted time. They try hard to manage the time spent by all parties during the audit to cover all of the agenda items. Their boss won’t know how deeply they reviewed your company and so covering the entire agenda and completing the “job” is much more important than delving deeply into any particular topic.
How to use this information if you are focused on compliance: Request the agenda from the auditor prior to the audit. If possible, try to get the auditor to agree to modify the agenda. You want to review your stronger areas earlier on. During the audit, try to disrupt the auditor’s schedule by having them focus more on your stronger areas. Ask many questions and try to prolong discussions in those areas. This will leave less time for the auditor to superficially review your weaker areas later on. Even better, tell the auditor interesting things about your technology, company, country and culture. Find out their personal interests and have non-work related conversations. By consuming the audit time you reduce the depth of the investigation because the breadth of the scope is fixed.
How to use this information if you are focused on quality: Take a systemic view of the audit. If one particular finding is made in one area, consider your analysis and decision process that led to that outcome. If you can improve in the area found during the audit, where else in your business can you use the same rationale to come to different conclusions? Rather than just apply a band-aid solution here or there, can you make any sweeping changes to improve quality or simplify the way you do things across the board? Effectively you use the opportunity to conduct your own parallel audit. Rather than be defensive, keep an open and inquiring mind. You may identify worthwhile opportunities for improvement by yourself even when the auditor misses them. Also, leveraging the auditor’s authority, you are more likely to get management support to implement your quality improvement changes when you highlight the fact that they were identified during the audit (no need to go on about “who” identified them).
Objective Number 4 – Minimize Follow up Work
Each audit is explicitly scheduled in the auditor’s diary.
The auditor is accompanied by company personnel the entire time, usually including break times and a lot of talking goes on. There is usually not much time for anything else.
Preparing the audit report is often unscheduled and the auditor tries to squeeze it in between audits. With a full agenda, it is not uncommon for a backlog of outstanding audit reports to build up. This is especially problematic in for-profit auditing organisations.
This time pressure can reduce the quality of your audit report. To make matters worse, subsequent audits conducted by the auditor can confuse them as to what was observed or said in which company. A subsequent audit conducted by the auditor with a better company can make your performance appear even worse and add more negative impact to your audit report. Conversely, your report could be improved if the subsequent company’s performance was worse than your own.
How to use this information if you are focused on compliance: Use all of the available time during the audit in discussions with the auditor so they will have no time to write the report. Once you receive the report, carefully write a response which details why any overly negative findings were off the mark and provide clear examples and evidence to support your argument. A response like that calls in to question the auditor’s professionalism and is embarrassing for them, their boss and their organisation. Request the audit report be resubmitted with the findings downgraded based on your argument and supplied evidence. They will try to put it to bed as soon as possible and it is unlikely the auditor will return to check things out. Provided your argument and evidence are good, the path of least resistance is for them to re-submit their watered down audit report.
How to use this information if you are focused on quality: Try to help the auditor spend some time alone at the end of the audit to start on the audit report. You will get a better, more targeted report if they write it up whilst the information is still fresh in their mind. Ask them if they wouldn’t mind just spending 30 minutes to start on the report and focus on the things they believe are most important to you.
Objective Number 5 – Look Out for New Opportunities
Auditing is boring. Sure you get to meet many different kinds of interesting people and see different factories and countries, but at the end of the day it is a lot of travel and time away from home, friends and family. The novelty soon wears off.
What’s more, the same issues come up time and time again in every place you visit. The same approaches are taken and the same mistakes are made. Seasoned auditors usually have a standard drill they go through and they carry out the same routine at every audit.
Sometimes the auditor may find herself auditing a particularly interesting company which seems exciting and enticing. Auditors are like normal people and eventually tire of working long, repetitive hours in a demanding job for an always too low salary. If they come across potential opportunities in other areas which could be more exciting and lucrative their minds fill with “what-if” scenarios and images of financial freedom. Same as anybody else.
How to use this information if you are focused on compliance: If your company has exciting prospects then don’t hide them from the auditor. Don’t make any promises but allow the auditor the opportunity to dream of being a part of your success. This will strongly influence the positiveness of the audit report when it comes out.
How to use this information if you are focused on quality: An experienced auditor may know what else is happening in your region, in the industry in general or even in your knowledge domain. If your company needs to acquire certain resources, such as new knowledge, people or equipment, the auditor may be a good networking contact to help you get it.
Are quality and compliance the same thing?
If you are compliant will you have quality?
If you have quality will you pass an audit?
If you have great quality will the auditor have no comments and tell her boss she has nothing to put in the audit report?
If everyone had great quality, what would happen to the “compliance industry” that relies on them not having it?
If quality is a carrot and compliance is a stick, what would you stop doing if the stick was taken away? Would you stop pursuing the carrot?
If not, then in today’s “risk based world of GMP”, perhaps you can justify to stop doing those things now.
At my previous job I visited a very large mutil-national here in Singapore. The company is ranked among the top 5 or so (by size) globally.
I accompanied a senior colleague and we met with the site Director whom he already knew quite well from years gone by.
The purpose of our visit was to sell GMP Training. What a waste of time…
The site Director took us from the meeting room to show us a very important picture… a pie chart. Whilst we were there offering one thing, it just wasn’t what he needed, as the picture proved…
The problems he has on site are not lack of technical knowledge. His operators don’t need more “training” (which always seems to be the panacea and the first company response whenever there is a GMP non-compliance issue).
His problem was universal and not GMP related at all. What he wanted to know was how to engage the workforce? How to make people care about what they were doing? How to align his staff’s goals with his corporate goals?
Very important questions and easy to get wrong. But easy to get right as well.
Their solution? Well they didn’t have one. The site Director was able to share a story which definitely was not even in the direction of the solution…
The site had requested to corporate to purchase some equipment for the princely sum of about SGD20,000 (chickenfeed for a site of that magnitude) which they had justified would help them significantly. The request was denied.
Not long after, one of the C-level execs visited the site on the company’s private Learjet which probably cost in the vicinity of perhaps SGD3,000 per hour to own and operate.
Should a C-level exec of one of the top 5 global pharmaceutical companies get to ride around the world in a Learjet? Absolutely! If not her then who? The rest of us may as well give up all hope to ever have that opportunity in the future unless somebody has it now.
Should one of the top 5 global pharmaceutical companies support their staff to make them feel valued and trusted and to demonstrate appreciation for their desire to do good? Absolutely! Even if the 20 k made no impact on the product at all, it would have been an excellent investment in “human capital”.
Are companies who pursue cost savings above all else destined to become or to remain the most profitable they can be? No. Whilst management is obsessed with cost saving, profit can only decline. But “absence blindness” means they will never even know about the critical effect of their lack of focus on making money.
Focus is the concentration of energy or attention on something. By definition, you cannot focus on saving money whilst at the same time focus on making money. Nobody ever “saved” their way to prosperity… they “earned” their way.
11 years in the making! The Compliance Appliance provides an easy to use, powerful, scalable, high availability, bullet proof Quality Management System which is fully compliant with every GMP regulation in the entire world. We guarantee it or your money back!!!!
And it’s cheap too! But its not a software solution.
Want one? Well, we don’t sell it over the Internet (yet… the good news is it will be available online very soon) because our compliance guarantee is not for a quality solution, but a logistic solution!
Yes, the solution to the root cause of GMP non-compliance which has plagued and retarded the over-regulated Life Science industries for the last two decades requires a logistic solution, not a “quality” solution and more useless “GMP Documents”.
We will reduce your documentation burden by as much as 86%. That’s 86% less documents for 100% compliance.
When you buy from us you do get a nice shiny little black box appliance (actually its matte black) like the one in the picture above, but unfortunately that, alone, will not solve all your problems.
What will solve your problems are business logistic changes like:
- A centralised task scheduling system which harnesses the power of division of labour to improve overall business system efficiency.
- Group calendars for task and production scheduling so everybody who needs to know what’s going on knows it.
- The three fundamental procedures necessary to implement a system of ongoing quality improvement (yes, our QMS has just three Procedures! Hehehehe. Thank you Mr. Shewhart for your 60 year old inherent simplicity).
- A single, catch-all Form that is used for everything (yes, our QMS has one Form! Hahahaha. But we do use automated form guides for pre-printed content).
- A business measurement and reporting system that helps you identify the drivers of business performance improvement (here’s a clue… measuring time and attendance is NOT a driver of business performance… don’t do it).
- 2048 byte RSA encryption and MD5 hash algorithms (ooh, very technical) which assure both the content and the authenticity of your documents. That means digital signatures which exceed the hopelessly misguided 21 CFR Part 11.
- Automated inventory management throughout its entire life cycle with automated replenishment triggers (for both inwards and outwards goods).
- Automated generation of your Batch Manufacturing Instructions and Records.
- Automated Learning Management System which routinely schedules knowledge maintenance tasks for all staff (that’s right, learning is treated as a preventive maintenance activity for people! It’s regular and ongoing and the records produced show understanding and competency, not just attendance).
Basically you get a fully operational, GMP compliant business for the cost of a cup of coffee (well, almost… actually compared to most other “consultants” in our industry we charge about half as much and deliver between four and 10 times the capability to our customers… we know because we used to work with other consultants and, with some of them, it’s pitiful how much customer’s have to pay and how little they get… GMP expertise costs, especially when you can never be wrong and nobody knows what you’re supposed to be doing in the first place! It’s a joke.). So the way we see it, we have a value multiplier between 8 and 20 compared to other “GMP” offerings.
The value is all of that compliance for:
- A one off purchase price.
- No software licence fees.
- Optional support contract.
- Unlimited and free access to future functional upgrades and improvements.
- Membership to our free knowledge sharing network. Share content like plans, procedures, specifications and test protocols and easily integrate them into your system. You’ll save a small fortune compared with developing your own in isolation and have access to industry best practices.
But the most significant value of all is that we make compliance go away. You will never have to worry about it again. It just happens. It becomes a low level administrative part of your business where it belongs so you can focus on what’s really important and why you’re even here in the first place – Sales and Fulfilment. To make more money, now and in the future.
Guaranteed, or your money back!
Never, ever, ever write that. It is a blatant lie, because once you write that the page is no longer blank. Was it your intention not to have it blank? Why lie about it?
Also it is a terrible waste of our limited resources. At some point in a future dystopia , when everything is quickly running out, writing it will be a crime.
We don’t mind slaughtering a few sacred cows. I hope that doesn’t disenfranchise any Hindi readers (although, as I read, the cow is more taboo than sacred).
Of course, here we’re talking about sacred cows in a business context…. ideas, concepts and practices which are simply the way they are and always have been. Nobody questions them.
They are so often “policy constraints”. Management decisions which restrict the business from achieving greater performance. Usually they were introduced a long time ago, based on decisions and assumptions which are no longer valid.
The best way to slaughter a sacred cow is to ask “Why?”, and keep asking it… Sakichi Toyoda’s “5 Whys”!
It’s often surprising to people when they get to the end of the root cause investigation that they find out nobody knows why a certain practice is being followed, or what those 2 letters in front of every batch number actually mean, or why there are so many procedures, instructions, forms, logs, etc. all with duplicated information.
People usually have a huge emotional investment in the way things are and generally resist change. Their reasons to resist are well justified in their own minds but, at the same time, they will change if they can see the reasons to change are well justified. The plus of changing must be big enough and the minus of changing small enough to outweigh the plus and minus of staying the same. People are not stupid.
The biggest problem is that when you go to work every day and are surrounded by sacred cow’s eventually they just blend in to the background and you don’t even see them anymore. They just are. Hard to improve when you can’t detect opportunities for improvement.
When we visit a company we have the advantage of seeing those cows for the first time and they are very obvious to us.
So, we slaughter them first and ask questions afterwards.
That gets people thinking anew about the direction of the solution to the underlying problem.
Well, our first project is underway! Hooooraaaaay!
The project is with a small but very progressive Traditional Chinese Medicine (TCM) manufacturer here in Singapore. They make capsules and tablets and have over 80 products.
We have guaranteed them GMP compliance within 8 weeks. One week down, seven to go. If we don’t achieve it we have to give them 50% of our fees back.
We are reorganising their entire operations around a Central Scheduler resource that will manage the logistical operations within their fulfilment departments (warehouse, production, QC). By using this powerful and proven “division of labour” approach we free up the other fulfilment resources to concentrate on fulfilment.
Using the Central Scheduler is a subordination step (step 3 in the 5 focusing steps of TOC). Currently they have a market constraint and we hope to address that next after this predominantly GMP Compliance project is finished. At least fulfilment will be poised should the constraint ever move back inside the business and we just need to put in an s-DBR solution to exploit the internal constraint at that time.
So it’s early days yet. We’ve done some training on the new approach (actually the 60 year old approach) and people seem to understand it well enough. It’s a lot easier to digest when you eliminate all of the misinformation, duplication and confusion written (on purpose?) into the GMPs.
This is an excerpt from an article on Money Morning Australia, the authors of my favourite daily newsletter of all things contrarian (well, mainly financial but plenty of other interesting notions too).
….You wouldn’t believe the amount of red-tape and regulation in the financial services industry. It seems as though everything we write or say has to come with a disclaimer.
The red-tape for stockbrokers is even worse. The regulations are so bad that it’s hard to get a broker to give you an opinion on a stock. And we don’t blame them. If a stock tip goes bad, they’re worried the client will sue them.
So it didn’t surprise us to see the report in Wednesday’s Age that:
‘[A]n internal report at Macquarie Private Wealth, which found more than 80 per cent of the division’s private client advisors were in breach of compliance standards.’
The report doesn’t state the severity of the compliance breaches. But our bet is most of them are minor rather than serious errors.
But the finance industry isn’t the only one drowning in red tape.
The drug industry is another. The approval process for new drugs is measured in years rather than months or weeks.
All along the route, the government agency needs more proof the drug works. Meanwhile, hundreds and even thousands of people die or get sick.
But even when a government agency approves the drug it has to come with all kind of warnings about possible side effects. In other words, before you take the drug, make sure you’re really sick because this drug could cause all manner of harm!
Of course, the argument is that the government is just worried about you. It wants to protect you. It doesn’t want you to lose money. And it doesn’t want you getting sicker than you already are by taking a drug.
But, there is one industry where the government isn’t quite so worried about your health. In fact, in this one specific industry, the government would rather you didn’t find out about the risks.
Because if you believe the advertising, there aren’t any risks. There’s only excitement, experience and training. Sounds great, right? So, what is this wonderful industry?
It is the Australian military. Or as they prefer to call it, the Australian Defence Force (ADF).
A Military Sampler
You’ve probably seen the ads for the ADF on TV…learn a trade…travel the world…get new skills…and potentially get a bullet through the head.
Oh that’s right, the ads don’t mention the last point, even though the primary (and arguably, sole) purpose for an army, navy and air force is to send young men off to kill or be killed.
But killing young men (your sons, fathers, brothers or husbands) isn’t good enough for today’s politicians. They want to kill your daughters, mothers, sisters and wives too.
The following report appeared in the Age two weeks ago:
‘The military will offer women temporary “try before you buy it” deals to encourage them to take on full combat roles, and replace some exacting physical requirements with more practical tests for both sexes.’
There are two disturbing aspects to the report. First, it was written by a female journalist – Misha Schubert. We would have hoped that rather than a warm and cuddly story about women’s rights taking another step forward, the article would have pleaded with women to not fall for the government’s dirty trick.
The other aspect is the use of the phrase ‘try before you buy it’.
It’s as though joining the military is like test driving a car, trying on a pair of jeans, or sampling the food at a restaurant.
But we’re not sure they’re the same. Just how do you try military combat? How would it work?
Well, let’s see: how do you like that mortar fire that’s just blown your leg off?
And what do you think of the hollow-point bullet that’s just blown your insides to the outsides?
What’s that you say? You’re not keen, never mind, thanks for trying anyway, here’s a coffin for you.
‘Terrific’ News for Women
But that’s not all. Even the Australian sex discrimination commissioner, Elizabeth Broderick is in favour of putting women in the firing line. As she told the ABC:
‘And I think…it is terrific that women will be allowed into every single role across Australia’s Defence Force…
‘Where are we going to start? We’re going to start in recruitment. So the – when we looked at it, the most successful program to recruit women into the ADF was the gap year. So the gap year was kind of scaled back for a variety of reasons. What we’ve said is those principles of “try before you buy” so that as a woman I can just – I have a minimum 12 months service, rather than sign up for 14 years at age 18…’
‘Terrific’ isn’t exactly the word we’d use.
Now look, let us make something clear. We’re not saying that the armed forces is man’s work and that women shouldn’t be allowed. What we’re saying is that governments and politicians have a lust for power and that leads to a lust for war.
As Ralph Raico writes in ‘Great Wars and Great Leaders: A Libertarian Rebuttal':
‘The King of Prussia, Frederick II (“the Great”), confessed that he had seized the province of Silesia from the Empress Maria Theresa in 1740 because, as a newcomer to the throne, he had to make a name for himself. This initiated a war with Austria that developed into a world-wide war (in North America, the French and Indian War), and went on to 1763. Of course, many tens of thousands died in that series of wars.’
This lust causes leaders to think that it’s OK to send young men (and now young women) off to war. And to make sure that no-one disagrees, they invoke the memory of past wars, dead soldiers and old soldiers.
Somehow remembering a previous pointless war justifies sending more young Aussies off to fight in a new pointless war.
And if anyone dares speak out against it, you’re labelled as denigrating the memory of the Diggers who have died.
No, that’s not quite true. We just don’t like power crazed maniacs (politicians) sending youngsters off to fight in pointless wars.
And the fact that the advertising for military service doesn’t mention any of the risks shows you just how deceitful these people are: ‘Don’t make that investment…and don’t take that drug…but hey, here’s a gun, go and shoot someone, and with any luck you’ll make it back alive…’
So perhaps in the spirit of fairness, so that the military has to make the same risk disclosures as the financial and drug industries, maybe military advertising should include something about the risks of joining the army, navy or air force.
Maybe the ads could recount the military blunders at Gallipoli, and warnings to the recruits about the potential ineptness of the officer class, who may not be as smart as they let on.
We really would like to see that happen. But it won’t. Because it would be a disaster for their recruitment campaign. Only those with a death wish would sign up.
Smarter Than Men
That said, perhaps we don’t have to worry about the fate of women who join the ADF. Because despite all the marketing efforts so far, it seems few women have fallen for the trap. As the Age article by Misha Schubert noted:
‘Despite months of intensive publicity over the year since Defence announced it would open frontline roles to women, the military says only three have so far expressed interest – all of them as naval mine clearance diver officers.
‘No army women have sought combat positions and the air force has not had any responses to its call for applicants. They navy is about to issue a call for formal applications from women, who can start from January.’
Hats off to Aussie women for ignoring this deadly advertising campaign.
Many women have claimed for years that they are smarter than men. We don’t know if that’s true or not, but based on these results it’s certainly seems like it has a ring of truth.
What we do
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We are based in Singapore but love travelling so feel free to invite us over for a chat.