The role of internal audits in MDSAP audits


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As MDSAP deadlines draw near companies are asking how to prepare for the MDSAP audit. The most basic step for the success of any management system is to say what you do and do what you say. When the system as documented is captured to reflect the “As-Is” of how it is done then implanting the system leads to conformity at all levels.
Auditing Organizations (AOs) that will come to assess the conformity of the system will be using a process-based approach to the audit as also prescribed by ISO 13485 and ISO 19011. As such internal audit teams too should be trained to conduct process-based audits. This will ensure that the organization will be ready and familiar with the way the AO audit will be conducted. Process-based audits also allow a better look at how the system is working to meet objectives. In the aerospace industry PEAR diagrams are used to identify the inputs, resources and controls for each process to better understand the interrelation of them within the process, whether they are sufficient and how they interact with other processes.
In the process audits for MDSAP the AO will first start with an audit of the leadership (top management) to appreciate their commitment to the system as also their awareness of the risks impacting their system and the actions, they are taking to address them. At each level the auditors will be seeking evidence of competence, documentation and data control and monitoring and measurement being done.
Internal audit teams should use a grading system familiar to those used by MDSAP auditors and as prescribed by HTF/SG3/N19:2012. The grading system follows a scale of 1 to 5 with 5 being the most severe. This will enable a realistic look at the state of the system. Auditors will also focus on the design and development and production controls from a risk perspective. They will assess how well the outsourced providers are controlled and what risks were determined in assessing the type and extent of control to be applied.
As with all systems auditors will want to assess that a system exists to identify and deal with non-conformities including implementation of corrective action within the defined time frame. Internal audit personnel can gain a better understanding of MDSAP audits and how to prepare by enrolling in QMII’s suite of course offerings tailored to various levels of the organization. Keep in mind that MDSAP audits are longer in duration as the audit time is based on tasks and not the number of employees.

Should you start using the system only after it is fully documented


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The word quality means different things to different people. To companies it often means delivering a conforming product/service to a customer aka meeting their requirements. To achieve this conformity consistently successful companies, implement quality management systems. Rather than re-invent the wheel, ISO 9001 is often selected as the standard to use to set up a quality management system (QMS) In addition, ISO 9001 training is provided to individuals at all levels within the company.
As companies start to implement the system ISO 9001 training can prove useful. Leadership is trained so they are aware of their role in the system and how they can positively contribute to its success. The personnel are trained so they are aware of their need to contribute and implication is they don’t. The project managers who own the project for implementing a QMS get training on the process to go about implementing the requirements of the standard as also their correct interpretation. Auditors are trained in an ISO 9001 training course designed to also teach the auditing requirements per ISO 19011.
So should personnel then start using the documentation as soon as it is complete or wait for the entire system to be documented and for the official launch date. If the system has been implemented correctly then the documented processes should reflect the way work is currently done and not a fictional process. It should not increase the burden for the users. As users start to use their newly documented processes, they can begin to provide feedback on its accuracy as well as the need for change. Personnel therefore should have to wait until the entire system is documented. Yes, organizations could however set an official launch date from which point forth records will be maintained. As such all data prior to the launch date is not then auditable nor is there a requirement to maintain it.
It should also be kept in mind that not every process needs to be documented as also that the organization can determine the extent to which to document the system. The extent to which to document depends on a number of factors including competency. ISO 9001 training is one way of increasing awareness of the requirements of ISO 9001 as also the system. Training may not always result in competency however.
At QMII a number of ISO 9001 training options are available and our training can be customized to meet the clients’ needs. The training is also available in an instructor-led virtual interactive format.

What are the functional requirements of the ISM code


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The ISM Code was ratified and brought into effect to improve the safety of shipping. With this was ushered in new era for the maritime industry. The ISM code was launched with the intent of getting companies to self-regulate and proactively mange risks. Companies that have embraced the ISM Code and not solely viewed it as a paperwork burden have reaped the benefits of the ISM code. Companies with ISM certification that have a well implemented system are able to proactively manage risks and thus able to save costs from saving the costs on dealing with non-conformities.
To gain ISM certification an organization must demonstrate that they have met the intent of the code and inherent in this is meeting the following functional requirements of the ISM code:

• A Safety and Environmental Protection Policy – To attain ISM Certification in the form of a Document of Compliance or Safety Management Certificate for the vessel the company must demonstrate that a policy is in place that shows how the company will meet the safety objectives of the code. It must be implemented at both shore and vessel.
• Instructions and procedures to ensure safe operation of ships and protection of the environment in compliance with relevant international and flag State legislation – These are essentially addressed by implemented SMS documentation meeting the requirements of clause 7 of the ISM code.
• Defined levels of authority and lines of communication between, and amongst, shore and shipboard personnel – The key words of between and amongst in this clause should not be missed. For the system to go beyond ISM certification the processes must work interactively to achieve the goals of the company and personnel must be clear on the expectations of them.
• Procedures for reporting accidents and non-conformities with the provisions of this Code – Identifying and addressing non-conformities plays a crucial role in the success of the system. With effective corrective action companies are able to ensure that the non-conformity does not occur again. This requirement is further amplified in clause 9 of the code.
• Procedures to prepare for and respond to emergency situations – ISM certification includes being able to demonstrate that a company can respond to emergencies at any time. To ensure this a designated person ashore is appointed who is available 24 x 7.
• Procedures for internal audits and management reviews – Internal audits and reviews to assess the effectiveness of the system must be conducted. Apart from the internal audits done by the company the Flag Administration conduct ISM certification audits prior issue of the interim SMC/ DOC as also prior the first full term certificate. Thereafter verifications are conducted at periodic intervals.
To learn more about how to implement and assess the effectiveness of implementation through audit enroll for QMII’s ISM Auditor class.

Gain more value from your Internal Audit with these five steps


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ISO 9001 internal auditors play a critical role in the success of the system. ISO 9001 internal auditors provide inputs to Top Management for continual improvement of the system. Internal audits, given the nature, can be more detailed and as such usually go into depth considering the limited scope of the audit. For audits to add value internal auditors should be trained in identifying the adequacy of resources and controls in a process to meet the objectives as defined. The five steps as listed below are inputs to enhancing your internal audit program as also supplementing the ISO 9001 internal auditor training.

Step 1 – Include risk in audit planning and preparation

In scheduling process audits, not all processes need the same amount of time allocated. Processes that are more complex and or have more problems may need more time to assess conformity. Processes which perform well could perhaps have their internal audit requirements met by auditing perhaps once a year. However, critical processes should be audited more often as also processes where customer complaints are received or where frequent issues are identified. There is no requirement per ISO 9001 to audit all processes within the timeframe of a year. Of course, in special industries like the maritime industry there is a requirement for annual audits.

In preparing for the audit the ISO 9001 internal auditor should determine priorities for the audit and select personnel they want to interview, the items they want to sample and quantity, as well as the questions they want to ask. All this will be based upon meeting of the audit objective and may change should there be a risk to meeting the audit objective. In interviewing of personnel auditors should choose a representative sample.

Step 2 – Use custom checklists

Checklists are a great tool for an auditor to go prepared for an audit. However, the purpose of checklists is not to limit the auditor. When standard checklists are used to audit a process over time the same areas of the process get identified while other areas get left out. Auditors may feel compelled to stay within the confines of the checklist unless advised otherwise. Auditees focus on “preparing” the areas of the process limited to the those that the checklist will touch upon.

Getting your ISO 9001 Internal Auditor to prepare checklists each time helps them to think outside the box and to perhaps change the sample and sample size selected. The auditee too now ensures that the entire process is working well and are not limiting themselves to perfecting to the “checklist” areas.

Step 3 – Choose your internal auditors from different departments

QMII recommends choosing and training internal auditors from different departments of the organization. At least 10% of the workforce should be trained as internal auditors. It is a small investment given that the company will now have a large pool of auditors to choose from. Choosing internal auditors from different departments enables cross-pollination of ideas and solutions. It also allows a better understanding of challenges being faced by the departments. Internal auditors from a different department using a custom checklist produce questions that are not normally asked, and the entire process is looked at from a fresh perspective.

Step 4 – Train your auditors in problem solving techniques

Training your ISO 9001 internal auditors in problem solving / root cause analysis is a unique skill that will allow them to see the big picture when conducting audits. Internal auditors when newly trained tend to focus on the minor issue not realizing that the issue may lie elsewhere. Problem-solving training gives them perspective into how the root cause of an issue may lie elsewhere and accordingly gets them to ask different questions and assess a process effectively. It also enables them to identify the problem (non-conformity) well to enable effective corrective action.

Step 5 – Evaluate both auditors and the audit program regularly

This is an important step that is often overlooked. Nearly all organizations will provide ISO 9001 Internal auditor training to their auditors, but rarely do they evaluate the effectiveness of the auditors or the effectiveness of the audit program. An organization needs to determine if its auditors are being too strict, too lenient, identifying the right non-conformity requirements, selecting the right sample, etc. Additionally, is the audit program as set up based on identified risks working well or do changes need to be made to the audit program. In our experience, companies follow the same audit program year after year. Auditors are rarely evaluated because there are only one or two trained and designated auditors. This step however plays an important role if the internal audit process is to be successful.

 

Authors Note: While the article is written from a perspective of ISO 9001 internal auditors the steps above are applicable to any internal auditing program.

What is ISO 14001 Lifecycle Perspective?


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ISO 14001 Lead Auditor training introduces students to the ISO 14001 standard and its interpretation as well as the skills needed to assess the effectiveness of the environmental management system. ISO 14001 in its 2015 revision introduces the lifecycle perspective. In essence, the standard asks organizations to use a lifecycle perspective when designing/manufacturing their products/services. This means that instead of a cradle to grave concept organizations need to think of a cradle to cradle concept.

Cradle to Grave

ISO 9001 ‘Requirements for Quality Management Systems’ ushered in a new era of process-based management systems that could be used to improve the quality of products/services being delivered to customers as well as when well implemented to increase efficiency and productivity. However, as productivity, efficiency and quality were being improved; the by-products of the system were not addressed. During the 1980s there were some regional efforts to address the impact of organizations on the environment and ISO 14001 was ISO’s effort to lay down the requirements for a management system that addressed the aspects and their associated impacts. Organizations were expected to take action on these impacts to reduce them. Auditors undergoing ISO 14001 Lead Auditor training were now ready to assess the effectiveness of these systems.

In its initial publication and subsequent revision in 2004 ISO 14001 asks organizations to take a ‘cradle to grave’ approach to managing their impacts on the environment. This meant reducing the immediate impact on the environment. However, with time we learned that this does not address the growing landfill issues being faced by countries globally. To address this issue as well as to align with international efforts to address climate change, rapid depletion of the planet resources and encourage sustainable operations the ISO 14001 standard introduced the concept of ‘cradle to cradle’ in its 2015 revision.

Cradle to Cradle

ISO 14001 defined lifecycle as “consecutive and interlinked stages of a product (or service) system, from the raw material acquisition or generation from natural resources to final disposal.” Life cycle stages can include the acquisition of raw materials, design, production, transportation/delivery, use, end-of-life treatment, and final disposal. A great example of a lifecycle perspective in manufacturing is the recycling of Lead-Acid Car Batteries. Nearly 99% of these batteries are recycled/reused. Major battery manufacturers have programs in place to encourage the recycling of car batteries.

While ISO 14001 does not call for a formal life cycle assessment ISO 14044 provides the guidelines for a life cycle assessment should an organization wish to do so. In determining the end of life disposal organizations may choose products that are recyclable, sustainable and even perhaps biodegradable. ISO 14001 lead auditor training provided by QMII, highlights the concepts of a lifecycle perspective and how to incorporate it into your environmental management system.

Conclusion

ISO 14001 Lead Auditor training enables participants to go back and implement environmental management systems that will benefit their organization, the environment, and stakeholders. It also enables participants to conduct value-adding audits of their systems. The intent of the audit is to identify opportunities for improvement. With the skills, ISO 14001 Lead Auditor training by QMII and the knowledge of a life cycle perspective participants are ready to hit the ground running in implementing and auditing environmental management systems.

 

Subchapter M is a positive Regulation from the USCG to improve safety


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Introduction. Industry maturity is essential in the implementation of any regulatory requirements. The reluctance of the industry toward implementation of the Subchapter M requirements is short-sighted.

Based on the analysis of casualties, tragedies and near misses, statutory bodies at the insistence of the executive (Congress as the representative of the citizens) propose regulations for compliance; to ensure the safety of the marine environment. The USCG is a premier internationally respected maritime authority and they have taken a lot of time to come out with Subchapter M, incorporating the best practices and lessons learned from years of implementation and enforcement of the ISM Code (toned down as required for the domestic towing industry in the US). Owners often, especially small businesses, see the initial investment as an expensive inconvenience. They perhaps fail to recognize the long-term benefits of safe operations using a system approach. An incident, accident, loss of life or marine pollution will be far more expensive than the initial investment. Not only to them but to the entire industry on the inland waters.

Appreciating Risks in the Context of the Maritime Environment. [1]This regulation may initially seem to many like another ‘policing’ activity by statutory bodies. When driving a car, people don’t wear a seatbelt to avoid being caught by the police. It is to keep the passengers in the car safe. The industry too must implement the Sub M regulations in the spirit of ensuring safety, mitigating risks in the context of the maritime environment and systematizing their operations. It is all about the PBMS (process-based management system) approach.

ROI (Return on Investment). Even without pollution or injuries estimated costs for the towing and barge industry are greater than $3 million. The cost of a closed waterway can amount to millions of dollars per day.[2] The NTSB concluded the probable cause of the grounding of the MODU Kulluk was, inadequate assessment of the risk for the planned tow of the Kulluk and implementation of a tow plan insufficient to mitigate that risk. As part of the Kulluk[3] team responsible for recommending safety measures, following the USCG & NTSB report them core reason for the incident is not surprising.  After all, “A bad system will let down a good person every time”.

Correct Implementation. This non-implementation of maritime safety regulations typically leads to tragedies. Every organization endeavors to produce a conforming product/service. Inspection before releasing the product to customer results in either clearing or rejecting the product or service. This dependence on inspection is a cost raiser. After all, rejection means delays and off-hire in the maritime industry. The intent should be to improve the auditing of the procedures comprising the management system so that processes result in a conforming product/service. The USCG has come out with the Subchapter M to provide that framework to create the management system, monitor it, inspect and audit it; thereby ensuring safety and in effect prevent loss in every way, including the loss of a vessel to a casualty. The industry must understand this aspect of the intended.

Learning from Tragedies. The tragic sinking of the Titanic a century ago is still teaching us lessons that we often neglect in implementing in the international maritime industry. I bring this international example as it has a lesson for the domestic industry. The SOLAS convention which was the outcome of the tragedy, investigations, and introspection by the maritime industry, further led to MARPOL, the ISM Code and later the STCW convention. The implementation of all these was dependent on the Flag States, then the issue came up, about the Flag States doing their job. Ships had the SMC[4] and other trading certificates; the maritime companies maintained some standards by them maintaining a DOC[5]. However, Flag States had no check. So, more regulations now, to bring the Flag States under the preview of the IMO with the IMSAS Audits to the III Code. More regulations are not the answer but are essential when implementers are reluctant to implement in the spirit of the regulation.

Lessons from the Sinking of the Herald of Free Enterprise. The example of the Titanic is essential as Sub Chapter M is implemented. The ISM Code is a good safety initiative to be implemented. The learning in its clauses has been at the cost of precious seafarers’ blood. One of the primary lead-ups to the ISM Code was the sinking of the Herald of Free Enterprise, a British RoRo[6] car passenger ferry on 7 March 1987 killing 193 passengers in near calm seas, when the vessel put to sea with the bow door open. A public inquiry into the sinking lead by Lord Justice Sheen castigated the ship’s owners when Lord Sheen “identified disease of sloppiness and negligence at every level of the corporation’s hierarchy”. This was almost the first time that instead of blaming just those at sea, those ashore were held responsible. It was this need for the operators and owners of seagoing vessels to have a management system with well-designed procedures that were to be resourced and monitored that necessitated the ISM[7] Code.

Role of TPOs. It is this ISM Code then which has been studied by the USCG and converted into the Sub Chapter M with all their expertise and wisdom. USCG is following the pattern of monitoring based on ROs[8] for international shipping by decentralizing and approving TPOs[9] for monitoring and controlling the implementation of Sub M. The purpose and objectives of these TPOs is not to interpret the Sub M to the convenience of the industry, but to implement the USCG intend to ensure safety.

This simple P-D-C-A, Plan-Do-Check-Act cycle is the magic in ensuring the TSMS[10]  or the MS as per USCG direction, works to ensure safety on board and for the others. A good plan based on company policy wisely converted into measurable objectives to drive the procedures, work instructions and the personnel on board and ensure leading to good implementation. The competence of the crews and top management motivated to understand this is essential for them and others who ply in our waters. The Check Stage should be all-encompassing with primarily getting inputs from objective auditing, enabling better decision making by the leadership based on objective inputs. The check stage is mainly the audits, but it should consider any other inputs as failed inspections, near misses, industry inputs and new emerging risks. This stage also includes reports from the USCG and so on. This stage is vital and requires good training of auditors[11]. Auditors and management who understand that “the only bad nonconformity is the one which is not known to the organization.”[12] The Act stage is often very neglected, where top management leaves the review to their second-tier management. If they are committed to the management system (TSMS), it is essential that the leadership conduct a management review at regular intervals, soon after a mishap and any time they are in doubt about the state of the system functioning. At each stage of the PDCA cycle risk must be considered.

The TPOs will be cleared by the USCG as per USCG procedures. A lot is dependent on them, as they will implement the Subchapter M requirements on behalf of the USCG. The Statutory USCG requirements are created to provide, the required oversight, to maintain stakeholder focus, to protect the interests of the customer when tow boats & services are certified. USCG has outsourced this to TPOs who should perform to expectations, be well resourced, have the infrastructure and create the environment for compliance in the spirit of the regulations. The TPOs should maintain organizational knowledge levels as also maintain competent personnel and take accountability for the effectiveness of the TSMS.

Options for Compliance to Sub M. The USCG has provided options to the towing industry to choose from to ensure compliance. In Option A -the “Coast Guard Option” per (46 CFR 136.130(a)(1)) offers the best for small towing companies who own just two or three vessels. This option requires annual visitation by the CG for the inspections. In Option B wherein the “TSMS” Option (137.130) would be the more logical choice, for larger operators, for convenience, and for the cost. It requires, either Internal (first-party) surveys to be overseen by a TPO or external (TPO) surveys, where the TPO conducts independent verifications to assess compliance at the appropriate times in the cycle. The USCG Certificate of Inspection (COI)[13] is valid for five years and requires a valid TSMS issued by a TPO.

Whichever option is selected by the company they have to see the value of their system. If it is a paper exercise, of course, it will not bring the results. The fear that this will increase paperwork is misplaced. The TSMS does mean a little more of system implementation and so a little increased paperwork is to be expected. Companies should not go overboard with paperwork. Refrain from over documenting your system or using a template that does not reflect how they operate. Increased operating & compliance costs are not necessary. There will perhaps be some initial costs to comply however, the cost of operating safely is much lower than the cost of an accident. Another fear owner may have could be the interference in their business. However, increased safety on the inland waterways benefits all including, boat owners and other leisure craft operators, crew members, the environment and the economy (ensuring waterways not shut down).

Conclusion. In summing up, based on my experience and involvement as also work with USCG, I can say this is a very well-intended, well-meant initiative to help the towing industry. The real joys will come from the correct implementation. Subchapter M is not only about compliance. It is about building a safety culture. It encourages the industry to streamline and reduce the paperwork that supports compliance/conformity, by greater use of technology, by identifying common areas and integrating documentation requirements as also motivating the workforce to use and improve the system. To use the reporting and monitoring systems, to build a culture of risk assessment / risk-based thinking and to explore measures to reduce the cost of compliance as also to improve monitoring and develop performance indicators. The early risk appreciation from data driving risks and NC[14]s driving Correction[15] and CA[16] will itself pay for the investment by providing confirming vessels as product and service of the industry.

 

 

[1] For the Context of the Organization guidelines refer to Clause 4 (4.1,4.2 & 4.3) read with Clause 6.1 of the Standard ISO 9001:2015.

[2] Transportation Statistics Annual Report 2017.

[3] https://maddenmaritime.files.wordpress.com/2016/10/tsac-1401-recommendations-kulluk-grounding.pdf

[4] Safety Management Certificate per the ISM Code.

[5] Document of Compliance as Per ISM Code.

[6] Roll-on roll-off.

[7] International Safety Management Code.

[8] RO: Recognized Organization representing a Flag State as per role defined in SOLAS.

[9] Third Party Administrators.

[10] Towing Safety Management System.

[11] https://www.qmii.com/iso-9001-training/

[12] Quote original by Dr. IJ Arora President and CEO QMII. www.QMII.com

[13] Coast Guard Certificate of Inspection.

[14] Non-Conformity.

[15] Correction is a quality term describing the immediate actions taken to address a NC.

[16] Corrective Action. CA is based on RCA-root cause analysis.